Ledderhose and Dupuytren's detailed radiotherapy interview

To be rewritten by patient due to change in condition

Patient series - Patient 5 Introduction

Initial Background Questions:

Please state your age, gender, country of origin and where you live (if different to origin) and how long you have had the condition?

I am a 49 year old female and I live in Virginia USA (I am from North Carolina) I first noticed nodules sometime in 2012.

Do you have it in both feet or any hands? 

I have it in both hands and both feet.

Please detail any family history or common risk factors which apply to you: 

My father has Dupuytren’s, as does my brother, two uncles and an aunt. (On my father’s side) I am the only one with Ledderhose. I have the progressive form of Dupuytren’s Diathesis.

Please list any treatments you have had, the time since you had them, the progress (or lack of) after treatment and any side effects:

I have had surgery on my left hand and left foot. It has come back with a vengeance on my left hand. I have horrible scar tissue on my left foot where I had surgery in June of this year.

Please detail any other information from your past which you think may be relevant and not covered in the monthly questions:

N/A

Monthly Questions:

1.    In the last month have you noticed any changes in the pain or size of the nodules? Or have any new nodules have developed? 

I find new nodules every day in my hands and the ones in my feet get bigger every time I feel of them.

2.    Please list a) The maximum pain b) the average pain c) the minimum pain you experienced this month and anything that improved or worsened the pain. 

It is unbearable to walk at all any more.

3.    In the last month what medication or treatments have you had, please describe in as much detail as possible including whether prescribed or home treatment, if applicable where the treatment was administered, by whom, cost (if happy to share) and how this has impacted the condition 

I can not take oral anti inflammatory medicines, so my doctor  has put me on a cream. I just started it so I’m not sure how it is going to work in the long term.

4.    Please describe how the condition has impacted you on a daily basis in the last month and any new steps (not treatments) that you have taken to try and alleviate this impact. 

I stay off my feet as much as possible. There’s really not much else I can do, or that I know of doing.

5.    Please describe the level of exercise that you have been able to achieve this month and any specific diets you have used if you think they have impacted the condition.

 n/a

6.    Please list any other information that you think would be useful.

I wished I knew of some…

Laser treatment Plantar fibroma patient from USA

Today I have an interview with a plantar fibroma patient from the USA, she has undergone laser therapy and shares her results so far....

1) Do you have Dupuytren’s and /or Plantar fibromatosis?

Just Plantar Fibromatosis

2) How old were you when you first noticed the fibroma?

67

3) Where are you from and do you consider yourself to have any of the common risk factors?

I was born in Butler, PA., USA of Scotch, Irish, German decent.

I have none of the known risk factors.

4) What treatment options were you initially offered?

I was referred to a foot surgeon who told me that there was very little successful treatment for this condition. He told me that neither he nor his patients were satisfied with the outcome of surgery or cortisone injections. 

He was working in conjunction with the University of Arizona researching the use of laser in the treatment of neuroma and was having some success. He thought that fibromas might also respond to laser treatment and asked if I would be interested in giving it a try. Faced with the other treatment options that seemed to not work, I chose to undergo the laser treatment he suggested.

5) How was the laser treatment?

The treatment was for a fibroma on my right arch which looked remarkably like the photo you posted of yours.  I received 14 laser treatments between July 27, 2013 and February 14, 2014.  Each treatment lasted approximately 14 minutes and only about 2 minutes involved moderate pain.  The first 10 treatments were one week apart.  The final 4 were approx.. 1 month apart.  In mid-October (part way through the laser treatment) we decided to include Verapamil Gel Therapy as part of my treatment plan.

At this point I was part way through the laser treatments and it seemed like it was working.  When Dr. Bocian suggested and explained the addition of verapamil gel, I trusted his opinion that this was a reasonable course of action for me.  

I had developed 3 very small nodules on my left foot, but they were not bothering me in any way so they have not been treated with the laser.

I used the gel 2 times per day on both feet and Dr. Bocian would apply it to my right arch fibroma immediately preceding the laser.  So the Verapamil was used 7 times with the laser on my right foot.  I continued to use the Verapamil gel on both feet 2 times per day for 9 months from October through June.  This concluded my treatment.

Today the nodules on my left foot remain small and asymptomatic, and the laser treated fibroma on my right foot cannot be seen and can barely be felt.  The pain is gone.  Occasionally I experience a very mild discomfort (where the restructured tissue of the fibroma is) with weather changes (we have no idea why this would be) or if I wear shoes with a high or padded arch.  The discomfort disappears when I change shoes or the storm front passes. I currently walking 7,000 – 8,000 steps a day and I attend 3 aerobic fitness classes a week.  All in all, I am very happy with the outcome of my treatment from Dr. Bocian.

As a side note – The laser treatments have not been approved to treat fibroma, so my health insurance covered none of the expenses.  The cost of the Verapamil Gel was $790.00.   I filed a request with my health insurance carrier to cover the Verapamil Gel and was denied.  I filed an appeal, since they did cover the use of Verapamil for other ailments.  There was much sarcastic laughter around our house the day I got the letter from them stating that they were going to reimburse me 22 cents for the sterile water used in the compounding of the gel !

Ledderhose patient treated with RFA and blood platelet injections

Today I have an interview with a patient from the USA, I came into contact with her through one of the many different forums / groups and she has had some treatments that sounded interesting. She was kind enough to answer my questions and provide a few pictures of before and after pictures. 

1) Where are you from?

I reside in North Dakota and part time California.

2) Do you have Ledderhose and/or Dupuytren's? 

Ledderhose

3) Do you have a family history of this condition? 

Unknown, my Dad had 16 brothers and sisters many I did not know.

4) How did you find the medical awareness of these conditions? 

I first noticed a lump but was very busy at the time, before I knew it it felt like I was walking on a golf ball. I went to Dr. Sabot at Mission hospital in Laguna Beach ca. He told me I had a plantar fibroma and by now I had a small one coming on the other foot also. But the one on my right foot was two large masses.

5) What treatment options were you offered?

Radio frequency ablation. I also had a bunion fixed on one foot which was the difficult part. The ablation was pretty much painless after and I definitely noticed a reduced and soften in both fibromas. I needed to return to the operating room to have the screw out which I was allergic too, he recommended the area of my large fibroma be treated again with blood platelet injection to decrease and soften it even more. 

6) What condition were you in when you were looking to get treatment? (Pain wise) 

I was about 7 out of 10 sometimes worse than others.

7) What is RFA? Please could you describe the treatment process you underwent with RFA and blood platelet injections? 

The definition for radio frequency ablation is as follows. Radiofrequency ablation involves the use of heat to destroy fibroid tissue. It is a laparoscopic procedure involving small incisions.

Ultrasound is used enabling the surgeon to see the fibroids clearly.

A long needle-like device is then inserted into a fibroid. When it is in the middle of the fibroid, heat is delivered until the entire fibroid is destroyed. The process is repeated until all of the fibroids have been ablated.

Each treated fibroid will shrink in size by about 40 percent within three months of treatment.

8) How successful would you say the treatment has been? 

3 years post op and I feel I had good results. However, Now I have a new one coming on the foot that had the large fibroma but it is going off to the side. He feels I should do Tenex on it. I am not convinced and I am doing research and getting more opinions. I think it was pretty successful  however and the blood platelet injections did push it along to soften more. 

9) What other treatment options are you looking into now and what are your thoughts on them? 

I have not found anything my insurance will cover. I am therefore considering paying out of pocket for something. I am not sure what however, nothing gets my hopes up. I am getting more opinions in California as North Dakota DRs just want to cut!

I am an aesthetician and have some pretty cool equipment so I have decided to use some of it on my fibroma and see what results I can get. Currently I am using cold hammer therapy with blue light. It really helps reduce inflammation and is soothing. I'm going to do it 3 times a day for 60 days and see if I notice anything.

Before rfa blood platelet injections:

After three years, now you can see one coming off to the side.

Interview: Ledderhose surgery patient from Ohio

Today I have a patient interview with a Surgery patient from the States. 

1) Where are you from? 

I am from Ohio USA

2) Do you have Ledderhose and Dupuytren's?, How long have you had them? 

I am a 49 year old woman and I have both Ledderhose and Dupuytren's. I have Ledderhose on both feet. I have had Ledderhose since I was an infant. My Mother first noticed the nodule on my left foot when I was less than a year old. She doesn't remember more specifically how old I was. So in answer to the question I have had Ledderhose for 48 years. It wasn't until much later that I noticed the nodule on the right foot. I have only had that one for about 8 years. I have only had Dupuytren's for about 6 years.

3) Do you have a family history of this condition? 

As far as I can find I have Absolutely NO family history.

4) How did you find the medical awareness of these conditions? 

Most of what I know about both conditions I have learned on the internet. The surgeon that removed the first nodule is the one that told me what it was called. I didn't get much information from him but I was only 16 and don't really remember much detail from the experience.

5) You had surgery, were you made aware of the risks of having this?

Yes, I have had surgery twice on the left foot. I was only told that it could come back. I was not told much else.

6) What condition were you in when you had the surgery? 

Looking back, I wasn't in bad condition at all. Knowing what I know now I would not have had the surgery then. The condition was stabilized and it had not grown for years. I was involved in things in high school that was most likely putting more stress on the foot and causing it to hurt more. 

7) Could you please describe the surgery process and recovery? 

The first time I had surgery (both surgeries were on the left foot) the incision was only about an inch long (twice the length of the nodule) and went across the width of the foot. They only removed the nodule and the surgery only took about 40 minutes. The time on crutches after the surgery was about 2 weeks. The second surgery was was about 5 years later and the foot had become very painful. Mostly because of the scar tissue from the first surgery but I also had a new nodule. The incision for that surgery was lengthwise of the foot and was approximately 5 inches in length and slightly curved in an "S" shape. They removed the new nodule that was about the same size as the first one. They also removed scar tissue about 1 1/2 x 1 x 1/4 inches. The surgery took about 70 minutes and had the same recovery period of 2 weeks on crutches.

8) How successful would you say the surgery has been? 

I am convinced that the first surgery only made things worse. I am also glad I had the second because I am sure if the nodule grew much more I would not have been able to be on my feet much at all. The second surgery didn't result in the large scar tissue formation like the first. Although in the 26 years since the second surgery I have another nodule and it is twice the size of the ones removed. 

9) What other treatment options are you looking into?

I am very interested in the Radiotherapy that has been discussed. I would like to know more about it and where it is offered in the United States. 

9) Is there anything else you would like to share with the patient community?

Picture on the left is the left foot. This is the one I have had two surgeries on. This nodule is about  26 years old. Picture on the right is the right foot. No surgeries. Nodule is about 8 years old.

Picture on the left is left hand. Not as noticeable since the nodules aren't as large as the foot but you can see that I have a pit of some sort. 

The picture on the right is also the left hand but the hand is turned sideways so you can see a bit more of how large the area is. The first nodule in the hand was noticed 5 years ago. Thankfully the right hand seems to be free of any nodules at this time.

Interview with RT and Hyaluronidase patient from USA

The following is an interview with a patient that has recently had Hyaluronidase injections with Dr Davis, see my interview with him here. 

1) Do you have Ledderhose disease, Dupuytren’s disease or both?

I have both

2) Do you have a family history of the disease or have any increased risk from other risk factors such as excessive alcohol consumption, smoking, diabetes etc.?

My father possibly has Dupuytren's, not officially diagnosed and not active. I do not drink, smoke, have diabetes or any other risk factors other than partial European heritage. 

3) How long had you had Ledderhose before considering each of your treatments?

The Dupuytren's started in my 20's (I think it started after carrying heavy buckets), I developed nodules which remained inactive for 20 or so years. Next I had frozen shoulder (which is also possibly linked) in one shoulder then the other when I was about 40 or so. My dup began to be active 5-8 years after that. After consulting orthopedic doctors who recommended doing nothing until the contraction was really advanced I researched and decided to have NA done. Which I did and was pleased with the results but wasn't splinting at night, so after about a 1-2 year time my hands (right in particular) to begin contracting again. The next procedure was not due to the advancement of the disease but because I got a sliver in the largest nodule on my right hand which got infected. I had to have surgery in order to stop the infection however the surgeon did not remove the Dupuytren tissue that went into my fingers because of the risk of the infection spreading into my fingers. So I had a partial removal of the diseased tissue, this was in Jan 2013. Since then I have 2 new nodules in other parts of that hand and the one up against my ring finger is enlarging. My left hand is contracting, but fairly slowly as I began to splint at night.

My Ledderhose started in 2011 when I began to notice a "thickening sensation" in the balls of my feet when I got up in the morning. And not wanted to deal with it I ignored it, ha that worked well. Anyway after a few months I began researching and decided to have RA in Germany which I did in Sept and Dec. Prof S increased the size of my target area because I did have something in the ball of my right foot which he thought could be a fibroma. I didn't have my hands radiated the first trip because I didn't think they were active at the time, but the second trip they were itching so I did have one treatment on my hands as well, but didn't go back for the second because of the advanced state of my hands the odds were not in my favour for much effect. My feet began to really hurt during the last 2 days of my second treatment. I began to not be able to walk much at all, which continued after getting home until I had the Hyaluronidase injection.

4) What sort of pain were you in before you had each of the treatments? 

I was never in much pain with Dupuytren's--other than a feeling of discomfort that my hand was out of alignment, just an occasional aching or rarely a sharp pain. Mostly itching when it is active. With my feet there was pain but not intense until after the 2nd round of radiation. Then my feet just hurt and I could only be on them for a few hours at a time and had to sit often. If I went shopping I used a wheelchair etc. and used it in my house just to relieve some of the pain. It got so bad that I wondered if it was more than just Ledderhose, especially because I do have some apparent fibromas in the balls of my feet which is not the norm.

5) I have not heard from a patient that has had the Hyaluronidase injections, please could you explain the procedure? 

I had an MRI before I decided to go to Dr. Davis so that I could try to assess if more was going on than the Ledderhose. But after I got to Dr. Davis' office he used a portable sonogram to check what was going on and he said it helped him to assess it better than the MRI because he could move my foot and watch to see how the nodules responded. He did not pressure me at all and almost didn't give me the hyaluronaidse because it just seemed my symptoms were so severe and different than other Ledderhose. My nodules never did get very big about the size of a large semi-squished grape. I opted for the injection and am so glad I did. The first time he spent quite a lot of time with me really examining my feet and then discussing orthotics and also a topical ointment. He then did a nerve block on my feet then a local anesthesia and then injected the Vitrase brand of Hyaluronaidse using the ultrasound to guide it exactly where he wanted it. The next day after the nerve block wore off it was almost like I had my "old" feet back. I was to go back in 3 weeks for the orthotics and also for another injection, which I did. This time I opted out of the nerve block (that was the most uncomfortable part to me) and the injection was not bad at all. The orthotics are to try to make me walk differently on the balls of my feet so the fibromas there will hopefully get some relief. I also just started using the topical because he is not comfortable injecting the areas in the balls of my feet because of the potential tissue damage there.

6) How did the Radiotherapy go? 

I think I answered this above. I really didn't notice any other side-effects except the pain after the 2nd treatment in my feet--no burning or redness or anything like that. The nodules in the arches of my feet stopped growing after this. Whether or not I had the all the other nodules in my feet at this time is questionable to me--I'm just not sure. My hands only had one treatment and they were already too far along to do much good.

7) How did the Hyaluronidase treatment go?  

I have no negative things to say about the Hyaluronidase treatment, the worst part as I stated above was the nerve block and having my feet asleep for the trip home and overnight. There was very little pain with the injections themselves and the results so far have been amazing --probably 80% better pain level than before.

8) How long ago was the Hyaluronidase treatment? 

My first injection was 4 weeks ago and the 2nd 1 week ago.

9) Would you say that the treatments have been worth it? And would you recommend any of them to people that have Ledderhose? 

I think these treatments are more than worth it. I cannot attest to the long-term results but I am thrilled thus far. I would have started with this without a doubt over RA. It has given me my walking life back , Hyaluronidase has been used for cosmetic procedures for years--If I have to do it again in 2-3 years I will, however that is not the norm according to Dr. Davis testimony he does not get patients who return and he has been doing this for over 20 years.

10) Do you have anything else you would like to say to Ledderhose patients?

I had given up and resigned myself to a wheelchair…this has given me hope, don't give up.

---------------------------------------------------------------------------------------------------------

This treatment appears to have very good results and I hope that continues for this patient and for any others that decide to have it. I would say that the time from the treat to now is clearly not enough time for the lumps to grow back.

From my interview with Dr Davis I know he claims to get very good results but given the lack of published medical data and the statement below recurrence is something that concerns me.

(Originally pointed out by Wolfgang on IDS forum)

For Dupuytren's contracture McCarthy wrote in 1992 "We reviewed ten hands in nine patients who had enzymatic fasciotomy for Dupuytren's contracture, with an average follow-up of 6.5 years. While all patients were initially satisfied with the results, the disease recurred quite rapidly to pre-operative levels in seven patients over the subsequent two to three years" http://www.ncbi.nlm.nih.gov/pubmed/1624874 

It will be interesting to see how things go in future years and to follow up with some patients that had this 5 or so years ago to see how they are doing now. 

The above patient is Penny on the IDS forum.

Update to Dr Davis Interview

Not that long ago now I did an interview with Dr Eddie Davis on the use of Hyaluronidase, this is an enzyme that specifically acts to reduce scar tissue in a similar fashion to collagenase. It appears that this has drawn the interest of many patients. I am already in discussions with one patient that has now had the the treatment and hopefully then will soon be providing answers to some interview questions. Another patient has seen the interview and decided they would like to know more, so they asked Dr Davis some questions and posted the results on the International Dupuytren's Society forum and have kindly allowed me to share them on here. 

Please see the interview here and scroll down to find the new questions and answers. It would be great if there was a published medical article on this treatment as it appears that the results are good for patients but many people, especially other medical professionals, would like to see some proof that the treatment works for the condition before the consider using it themselves. 

I do have some other Ledderhose news but I will wait for it to be more formalised before I consider posting another about it. There will also hopefully be a few more interviews on the way. 

Don't forget if you want to be interviews, point out a mistake or have a suggestion then please get in touch as I want to do all I can to make this site as useful as possible. 

Interview with patient who had minimally invasive surgery (Tenex)

1) Do you have Ledderhose disease, Dupuytren’s disease or both?   

Ledderhose only at this time.

2) Do you have a family history of the disease or have any increased risk from other risk factors such as excessive alcohol consumption, smoking, diabetes etc?

Possible Grandfather with Dupuytren's.  No other significant risk factor.  

3) How long had you had Ledderhose before considering Tenex? And what other treatments had you received / were you offered by medical professionals? 

I had the painful lump for about six months when I made the decision on Tenex.  I was offered surgery, but was told of the risk.  I did do shock-wave therapy which gave me some minor relief from the pain.  

4) Before Tenex were you made aware of the rate of reappearance after traditional surgery and did this concern you? 

Yes and while I won't totally rule out surgery, it will be a last resort.  

5) Were you at the stage where you couldn't walk before you had Tenex / what sort of pain were you in?

I can walk, but with significant pain.  I walk slowly and I must limit my walking and time that I stand on my feet.

6) Tenex is not that familiar to me, please could you explain the difference between it and regular surgery?

Tenex was originally called the FAST procedure and developed at the Mayo Clinic.  It is a focused aspiration of soft tissue.  No cuts are made.  A small needle goes into the nodule and it is removed by aspiration.

7) How did the treatment go? How long did the treatment take and what was recovery time like?

The procedure was very easy.  It took about 15 minutes total and I was able to walk out of the office and just stay off my foot for a day.  I was "supposed" to be that simple with no follow up necessary.  

8) How long ago was the Tenex treatment? Have the lumps grown back? If yes how long did they take to grow back and are they worse now? 

It has now been two months since the procedure.  It appeared to just be swelling right after the procedure, but now after 2 months, the lump is larger than before treatment.  I must give a disclaimer that the physician who treated me is insisting at this point it is a hematoma rather than a fibroma.  I am the first Ledderhose patient he has ever treated.  He did say it is possible that the hematoma is on top of the fibroma, but at this point I do not have a clear diagnosis.  Gary, I will update you by e-mail once I do and you have my permission to update this interview.

9) Would you say that the surgery was worth it? And would you recommend it to people that have Ledderhose? Would you consider having it again? 

At this point I would say it is an option, but it is not proving successful for me.  I will be pursuing other options once I can get a clear diagnosis from a physician.

10) What would you say your standard of walking is at the current time and do you think this would be different had you chosen not to have Tenex?

My standard of walking is worse since the procedure as the lump is larger and presses against any kind of shoe and even the floor when barefoot.  I was better off before the surgery and the lump was softer.

11)  What treatments have you tried since surgery?

Since it has only been two months, I have not tried anything other than ice/heat and massage.  Massage tends to annoy it and ice and/or heat have little effect.  The nodule does fluctuate in size as it always did, so some days are better than others. 

12)  What treatment options are you considering now?

Right now I am considering two options.  Either Hyaluronidase injections from the doctor you interviewed in Texas or Radiation Therapy.  They are very different procedures and I still have more research to do before making my decision.

More Information from patient:

Tenex is such a new procedure that the only information out there is from their website:  http://tenexhealth.com   The website lists the physicians that have been trained and are currently using the technology.  I called several doctors from the website and heard back from five of them that they had successfully aspirated fibromas.  I was treated by a doctor near where I live and I was his first fibroma patient.  He spoke to another physician that has successfully treated this condition and performed the procedure using that physician's protocol.  He did tell me that a fibroma is at the very top end of what they feel the Tenex device can handle as it is a small needle with a limited amount of power.  Thank you for all the work you do on your blog.  I have found it very helpful.  I will let you know how things go in the future and also what treatment I decide on next.  Best Wishes.

Follow up e-mail from patient: 

I had an ultra sound a few days ago and my doctor confirmed that the hematoma has healed and now he can clearly see the fibroma. It is also significantly larger than it was prior to Tenex. Feel free to update my interview. Because walking has now become difficult, I discussed RT and H. Injections with my doctor. He spoke with Dr. Davis in Texas and feels comfortable using his protocol. I've decided to go ahead with the injections. I would to glad to let you know how it goes. 

A patient experience of Cryotherapy and Verapamil

About 5 years ago, I developed a bump behind my big toe on my right foot.  I had no idea what is was.  I mentioned it to my doctor, who is a very well connected Dr, in Philadelphia.  (I drive 2 hours to visit him from my home town).  He referred me to Dr. Robert Cohen.

http://www.paolifootcarecenter.com/staff.html

I really had no idea what to expect, and sort of assumed that as long as it was not cancer, it was going to be no big deal.  Well, it was not a cancer, and Dr. Cohen confirmed it.  At this point, I had no real discomfort, but was worried about the bump.

He put me on Verapamil as the initial treatment, and it did not really do anything. 

Dr. Cohen subsequently did a cryosurgery on it, and I really expected it to be broken up and dramatically shrunken after the procedure.  I revisited a few weeks later, and the Dr. was quite happy with the change in size and shape.  I personally really did not notice any significant shrinkage, but it had become a bit elongated.

Over the next 2 years, I did the procedure 2 more times, with nominal results, that were duly noted by Dr. Cohen after he ran an ultrasound each time.

After the 3^rd treatment, I stopped going.  I really did not feel any great change, and I had not really had any significant pain anyway. 

I had been given a pair of orthotics to lengthen my arch, with a small shaping around the fibroma to remove some of the impact on it as well.

I went through the next 2 years, with no real concern about the fibroma, and I felt like the cryosurgery was pointless.

I have recently changed my mind.  The fibroma has gotten a little bit larger, and is much more painful.  I get the burning sensation that others describe.  In particular, each morning when I first put weight on it.

I will be going in February to have it evaluated again, and have a new cryosurgery.  I am hoping it will disrupt the fibroma enough to set it back to where it was just an annoying bump without the intermittent pain and burning.

The Cryo process: 

The surgery is really simple.  They numb the foot, cut a small (size of a drinking straw) hole in your foot, and insert a tube that forces cold (like a dry ice) into the fibroma. They continue this insertion until the point where the cold my damage other tissues.  You are wrapped in a sterile bandage, and your foot is wrapped in a hard paper boot, that diverts weight around the arch, and you walk out.

After 3 days, you take the bandage off, and put anti biotic on twice a day like a normal cut, and go about your business.

Cryosurgery is NOT a cure.  Not even close.  It may not even reduce the fibroma.  But, my instincts tell me that it did delay any increase in size, prevented pain within the fibroma, and was a good thing.

I would like to emphasize that my final thought in cryo is that it is a tool to reduce pain, nominally shrink and reshape the fibroma and slow the process down.

Interview with Dr Eddie Davis, Podiatrist that uses Hyaluronidase in Texas

Today I have an interview with Dr Eddie Davis. He is a podiatrist from Texas who treats using Collagenase Hyaluronidase, you can visit his website here. A patient interview is available here:

CORRECTION: I have had a comment saying this is not collagenase, this is correct, however it is an enzyme (that breaks down another part of the extra-cellular matrix, please see the update at the end as to the discussion that took place between the two doctors and also a link HERE to see a few more details on how the enzyme Dr Davis uses works.
 

1) How long having you been treating Dupuytren's and or Plantar Fibromatosis disease and roughly how many patients have you treated for these conditions?

I have been treating plantar fibromatosis for about 28 years.   I do not treat Dupuytrens' contracture as it occurs in the hand and I am a podiatrist.   We average about 8 to 10 patients a year with symptomatic plantar fibromatosis who require treatment.

2) How common do you think PF is in the USA? It is supposedly more common in males then females and has been linked to a family history of PF and Dupuytren's, smoking, alcohol consumption and diabetes are these risk factors you see in your patients?

I am not aware of statistics with respect to prevalence of plantar fibromatosis in the US but symptomatic plantar fibromatosis  is not common.  I believe that there are a somewhat higher number of patients with asymptomatic plantar fibromatosis out there who do not seek treatment nor require treatment.

3) You treat with something similar to collagenase injections, how is this enzyme derived and how does it differ from Xiapex/Xiaflex? 

Xiaflex is "collagenase clostridium histolyticum," which is a form of collagenase produced by a bacteria, Clostridium histolyticum.      Clostridium histolyticum is a bacteria that can cause severe infections including gas gangrene in humans.  The features that make this bacteria dangerous are utilized, in part, to a certain benefit.  The bacteria can spread through tissues rapidly by dissolving tissues via proteinase enzymes and collagenase enzymes.  Isolation of that form of collagenase yields the effective ingredient in Xiaflex which is used to break down excessive collagen in a controlled fashion.  Xiaflex is officially indicated by the FDA for Dupuytrens contracture only in the US.  It could be used in an "off label" fashion for plantar fibromatosis but there is no compelling reason to do so as there is no evidence that it is superior to other forms of collagenase utilized over the last few decades.  It would be significantly more expensive due to its' patent and third party coverage likely to be denied due to off label use.

Hyaluronidase specifically acts to reduce scar tissue in a similar fashion to collagenase and has been available for a long time.  We utilized Wydase, a form of collagenase manufactured by Wyeth Pharmaceuticals in the 1980s.  Wyeth discontinued Wydase.  We needed to obtain hyaluronidase from compounding pharmacies for a period of time in the 1990s until new manufacturers brought the product back to market.  I favor Vitrase, a form of hyaluronidase manufactured for opthamologic use by Ista Pharmaceuticals due to its relatively higher concentration, purity and being preservative free.  Baush and Lomb recently acquired the product.

4) What is the typical procedure for administering the enzyme for plantar fibromatosis and at what stage will you considered giving it?

Our criteria for Vitrase injections is based on the presence of painful lesions of plantar fibromatosis.  It has probably been more than 15 years since I have treated the lesions surgically due to the high recurrence rate with surgery and high success rated with hyaluronidase injections.

The procedure varies based on location of the lesions but a common scenario is as follows:

a) We perform a posterior tibial nerve block.  This is an injection into the nerve on the inside of the ankle that gives sensation to the bottom of the foot.  The purpose of this is to completely numb the bottom of the foot rendering the procedure painless. Plantar fibromas are often fairly firm lesions so too small a needle cannot adequately penetrate the lesions which is why the block is important.

b) The lesion(s) are visualized via sonography (diagnostic uitrasound).  The goal is to place the needle centrally within each lesion so that as much solution can fill the lesions as possible.  If the injection is too deep, that is, under the lesion, then the effectiveness is reduced as the active ingredients are not adequately penetrating the lesion.  If the injection is too superficial, then not only can effectiveness be reduced but leakage of the solution into the skin can cause atrophy.

c) The solution used is a combination of hyaluronidase, triamcinolone acetonide and a local anesthetic, usually Marcaine.  The amount and proportions thereof are a judgement call based on the size of each lesion and its firmness.  A more firm lesion may benefit from a higher percentage of triamcinolone acetonide.

d) We generally see a 30 to 40% reduction in lesion size after 3 weeks.  A second injection may then be performed which will usually involved use of a smaller amount of solution.  Occasionally, a third injection is required.

5) What is your success rate using this treatment? Due you often use multiple injections? And are there any side effects?

I would place our success rate at about 95%.  I am only aware of two patients for whom this did not work in the last 15 years or so.  Sonographic guidance is not necessarily a requirement but, I feel, prevents the only potential side effect which would be atrophy of the skin and subcutaneous tissue which would occur if the needle is placed too superficially or if too much fluid is used which would lead to leakage of the excess fluid into surrounding tissues.

6) Why are these injections a better course of action than surgery, radiotherapy or cryotherapy? Can the injections be used after the previously mentioned procedures?

Cryotherapy and radiotherapy are non-specific therapies.  Both are destroying tissue in a non-selective fashion.  Collagenase and hyaluronidase, like all enzymes, have very specific functions and target tissues/reactions.  The prime directive is to "do no harm."

7) Generally I find that only surgery is well known in the USA, why do you think this is?

I cannot answer that without stirring up a hornets nest.  It is a political issue.  The US system of medical politics has, for years, had a strong bias toward aggressive surgical approaches.  I do a relatively high volume of surgery and certainly am not anti-surgery but there are times when non-surgical treatments are superior and need to be more objectively considered.

 I thought that his response to question 6 was interesting, not because it is not true but because I think there is more to it than meets the eye, so I replied to him with a follow up statement to try and get more information from him: 

One of your pros for Collagenase over radiotherapy and Cryotherapy is the specificity of treatment. I do not have a significant amount of knowledge for Cryo but I am sure it is also an ultrasound guided procedure to ensure that it is only the lump that it is hit with the treatment, although I think I appreciate that your point was more that Collagenase treatment is specific to the cause of the disease rather than Cryo which is not specific.

As for radiotherapy, you could argue, given that it is low dose treatment, that although all tissues will be hit with radiation that due to their proliferative state it will be the disease tissue that is targeted as these are the main replicative tissue and it is under replication that radiation is truly effective and through this means the radiotherapy is specifically targeting the disease.

While Collagenase is injected into the cells if it does get to other cells it could breakdown any collagen as the collagen in the diseased tissue is the same as that in the non-diseased tissue but is just more abundant. 

I received the following response: 

Certainly, if cryotherapy is well targeted, it can limit damage to surrounding tissues. Nevertheless, the simple act of cutting into tissue or destroying tissue initiates an inflammatory response from the body which includes production of more scar tissue. Our bodies make enzymes such as collagenase since we are regularly breaking down and rebuilding/repairing tissue. The repair process becomes "flawed" in areas of chronic inflammation or low vascularity leading to deposition of poor quality tissue, that is, tissue that may have excessive fibrosis and be hypovascular.  If there was a way to signal our body to correct the flawed repair process then entities such as plantar fibromatosis and fasciosis/tendinosis would not occur.  ESWT, for example, is a means to stimulate the body to remodel such tissue; a regenerative technology.  Tissue remodelling or repair would involve secretion of enzymes to break down unhealthy tissue and neovascularization (production of new blood vessels)  by the body to ensure that repaired tissue remain healthy.  The introduction of such enzymes initiates a process that is a close to the process intended by nature as possible.

Regeneration of damaged tissue may involve use of enzymes to assist with the breakdown of unhealthy tissue, stimulation of reparative processes by treatments such as ESWT, use of growth factors (either synthetic or from the person's own body such as platelet rich plasma).  The frontier of such technology would also involve angiogenesis factors, that is, substances that induce formation of new blood vessels in tissue.  Cancer cells, for example, aggressively secrete angiogenesis factors allowing tumour formation via reduction of contact inhibition and the building of blood supply to such growths.  Identification and isolation of such angiogenesis factors would be a boon to the science of tissue repair. 


Addition on 28-03-2014:

The following information has been provided to me by a user from the International Dupuytren's Society forum who contacted Dr Davis after reading the above interview and is posted with permission from them and Dr Davis, the original responses can be found here. 

1. Does the shrinkage of the fibromas decrease the progression of the disease? Or is it likely that you will continue to develop new nodules/fibromas?

The exact cause of plantar fibromatosis is not known so the effect of treatment on existing fibromas with respect to future nodules cannot be determined. Based on my experience, I have rarely had patients return with new nodules.

2. How many nodules can you treat at a time? Can you treat both feet at a time?

There is no limit to the number of nodules that can be treated at one time. Both feet can be treated at the same time. It would be normal to experience some discomfort once the numbness of each injection wears off so one need consider that.

3. I understand it may take more than one injection, why is that the case? And, typically how many injections are needed for each nodule? If multiple injections are necessary what is the time spacing between injections?

There is a limit to the volume of fluid that can be placed into a nodule. The nodules are largely composed of fibrous or scar tissue and have little expansion when injected so attempts to place too large a volume of fluid into a nodule would result in leakage of the fluid into surrounding tissues. Each injection provides about 30 to 40 percent shrinkage so one injection would not provide adequate treatment. We average two to three injections about 3 weeks apart.

4. Is there a difference in success rate of this treatment when treating early, and active Ledderhose?

I do not have sufficient information to answer that question. Most patients I have treated have fairly advanced nodule formation as treatment information about this is a bit sparse with the majority of medical advice favouring surgical treatment.

5. Are there any short term or long-term side effects to the treatment?

Short term: one to two days of tenderness. I am not aware of any long term adverse effects of treatment.

6. Is there "down time" to treatment where you need to be off your feet?

Down time is related to the number of lesions injected. It averages about 24 hours.

7. How much pain is associated with the actual treatment?

Pain varies from patient to patient but most patients find the treatment very tolerable. Depending on nodule location, we may inject them directly or perform a nerve block (posterior tibial block) which renders the sole of the foot numb before performing the injections.

8. How often do you see nodules that are treated come back or grow again?

I rarely see regrowth of nodules, probably less than 5%. A more common scenario may occur when there have been too few injections and nodules are not adequately shrunk, there is residual discomfort or pain.

9. I understand your success rate is close to 95%. Can you tell me roughly how many patients you have treated with Ledderhose?

About 105 to date.

10) It is my understanding that the H. injections that you do vary from the collagenase injections and therefore, perhaps, are more promising and successful?

Collagenase, in theory, should work as well as hyaluronidase. Unfortunately I have no experience with collagenase due to the expense of Xiaflex and because I have been happy with the hyaluronidase "technique" I use. One may consider the technique itself, which may not be consistent from provider to provider. I mix hyaluronidase with a small amount of a repository steroid, generally triamcinolone acetonide as well as a local anesthetic then use sonography to guide the injection into the center of the lesions. If the injection is too superficial then there is a risk of atrophy of the subcutaneous tissues, if too deep then, a potential loss of effectiveness. The goal of the injection is to create a zone of lesion atrophy in the center of the lesions such that the lesion collapses on itself. I have used sonography to aid the injections for about 9 years or so and feel that it does enhance the results.”

11) Have you through the years of treating patients formulated any of your own studies?

No. Would be interested in doing so. Currently, we could do case reports or possibly a retrospective study. Despite my personal experience the numbers of patients treated (by all the methods) is not large which makes statistical analysis problematic.

Statistics are sparse for all modalities. I am not aware of studies of any significance. The forums may be a means to attempt to gather statistics, perhaps in a retrospective study. Another issue to consider is that many of my patients travel from out of the area for the treatment so a portion of the results achieved is based on subjective information about results but not "before and after" measurement of the lesions. We encourage local patients to return to the office but, typically, when travelers from outside the area communicate relief or resolution of symptoms we do not ask them to return for an exam. A multi-centered research project would be optimal. Our treatment protocol tends to work the best on large lesions. We have seen two patients in the last year who had RT previously.

We know that hyaluronidase injections are relatively safe as hyaluronidase has a number of other uses; that is, experience with that enzyme is relatively large considering its range of applications. It is safer than RT although RT, when focused on a small area can be relatively safe. I believe that all should consider the maxim, "first do not harm." There is insufficient information with respect to long term efficacy of hyaluronidase but can only state that my "redo" rate is very small. I favor treatments that are as specific as possible. So in the case of a benign fibrous (scar tissue) growth, use of a agent highly targeted at that tissue such as collagenase or hyaluronidase seems best. Xiaflex is a relatively new brand name collagenase
indicated for Dupuytrens contracture. I called the manufacturer when it first came out. They had no plans to obtain an indication for plantar fibromatosis due to inadequate numbers of patients and were cautious to discuss that subject due to recent FDA penalties for the promotion of "off label" uses. It is costly to obtain an FDA indication for a drug. One legal means around that is to obtain "orphan drug" status.

Eddie Davis, DPM, FACFAS

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COMMENT BY DR CHRIS BAINBRIDGE (on Original post in which I mistakenly included the word Collagenase): 

He does not treat with collagenase.  he treats with an injection of steroid to which he has added hyaluronidase NOT collagenase.  The enzymes are totally different.  Everybody injects dupuytrens nodules with steroid if they are really painful.

REPLY BY DR DAVIS:

That is correct, the enzyme is hyaluronidase.  We use the Vitrase brand of hyaluronidase.  Xiaflex is a brand of collagenase. They are different enzymes but with similar effects on scar tissue so the comment about "totally different" is a bit misleading.  Also misleading is the comment "he treats with an injection of a steroid which he has added hyaluronidase" as that appear to be an attempt to to de-emphasize the role of hyaluronidase.  Perhaps a more accurate statement would be "he treats with hyaluronidade to which he has a added a steroid, triamcinolone acetonide, and a local anesthetic."

A quick addendum:  enzymes are entities that react with specific tissues in the body.  For example, collagenase breaks down bonds in collagen and hyauronidase breaks down hyaluronic acid. Connective tissue in our bodies have a number of components and each enzyme will target a specific component due to its specificity. What matters is the end effect or therapeutic effect that will be achieved.  We can look at a painful overgrowth of connective tissue and reduce by "attacking" different components of that tissue.