Enzyme injection (collagenase) to treat Dupuytren's contracture
A study reports of controlled phase-2 clinical trials, where excessive collagen deposition in Dupuytren's disease (Dupuytren's contracture) has been targeted by a non-operative method using an enzyme (Clostridial collagenase) injection to lyse and rupture finger cords causing metacarpophalangeal and/or proximal interphalangeal joint contracture (contracture at the base or middle joint of a finger). The study demonstrates bent fingers that got straight again within a month, not in each case but in most. The study proposes enzyme injection as a safe and effective method of treating as an alternative to surgical fasciectomy: "In fact some of our patients who have had fasciectomy on one hand but have been treated in our trials for the contralateral hand have commented in glowing terms that the less invasive injection treatment was far superior to their surgical experience. … To date our recurrence rates are low in the clinical trials described and are < 5% at 4 years from our first open-label clinical trial using 10,000 U of collagenase. There have been no disease extensions to other fingers." Link:abstract_enzyme_article full text see below.
There is already good and longer term evidence of the therapy's effectiveness. After the completion of phase 3 of clinical trials and the assessment of possible side effects, this therapy might become another main therapy on our web site. Yet progress of phase 3 is slow and approval by FDA may take another one or two years.
Phase 3 Trial of Collagenase completed
Recently the phase 3 trial has been completed. Participating US clinics are e.g. listed at list_of_collagenase_clinics (CORD I trial) and Australian clinics (CORD II trial) are listed on list_of_AU_collagenase. Results of the trial are described in the most recent of the below cited papers. Approval of the FDA is now awaited for 1st Quarter 2010.
If you are interested in experience of patients with collagenase injections please visit our forum, e.g. the threads "Auxilium AA4500 Phase 3 Clinical Trial Experience" and "Auxilium AA4500 Trials Report".
For a while collagenase was provided under the brand name AA4500. The current brand name used by its manufacturer Auxilium is Xiaflex.
Video of collagenase treatment
Below are several YouToube links from a patient who documented various phases prior, during, and after her collagenase treatment. It does not show much of the procedure itself but shows results and related feelings.
A more advertizing video, also showing Drs. Maria Badalamente and Lawrence Hurst, the inventors of the collagenase treatment, is on
http://video.aol.de/video-detail/frozen-finger-fix/446064678
Collagenase and NA - what is the difference?
The treatment of Dupuytren's contracture with collagenase injection is similar to needle aponeurotomy (also called NA or needle fasciotomy). Both treatments address already bent fingers and both start with weakening the contracting cord. NA does this by stitching a thin needle several times into the cord and thus weaking it mechanically. Collagenase does this weakening by injecting a small amount of collagenase, which locally weakens/dissolves a small fracture of the cord. After this weaking step both therapies stretch the finger mechanically until the weakened cord actually snaps and the finger becomes straight again. The difference between collagenase and NA is essentially the way by which the cord is weakened before it is broken mechanically. Injection of collagenase is therefore sometimes also described as enzyme fasciotomy.
Collagenase for Ledderhose disease and Peyronie's disease
Collagenase is not yet tested for treatment of Ledderhose disease, maybe due to smaller market opportunities or maybe due to dominating nodules rather than cords. - Collagenase has been proposed as therapy for Peyronie's disease and is currently in a phase IIb trial to get approval auxilium_press_release.
Literature on collagenase injection as therapy for Dupuytren's contracture
With permission by ASSH and Elsevier (thank you to both!) we publish the full text of two original papers on the use of collagenase for treatment of Morbus Dupuytren.
Marie Badalamente et al. "Collagen as a Clinical Target: Nonoperative Treatment of Dupuytren's Disease" The Journal of Hand Surgery / Vol. 27A No. 5 September 2002, p 788 - 798
Marie Badalamente and Lawrence Hurst "Efficacy and Safety of Injectable Mixed Collagenase Subtypes in the Treatment of Dupuytren’s Contracture" The Journal of Hand Surgery / Vol. 32A No. 6 July–August 2007, p 767 - 774.
Lawrence Hurst et al. "Injectable Collagenase Clostridium Histolyticum for Dupuytren’s Contracture" N Engl J Med 361 (2009) p 968-79. This paper includes results of the phase III trial. -- We are awaiting the approval from the publisher to provide the full text on our web site. In the mean time you can buy the article from NEJM or contact the authors or Dupuytren Society for a copy. abstract.
Page last modified: 12/17/2009