Musculoskeletal Diseases

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Nervous System Diseases

Contracture

Dupuytren Contracture

Joint Diseases

Muscular Diseases

Fibroma

Neoplasms, Fibrous Tissue

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Connective Tissue Diseases

Participants in this arm of the study will be treated once with needle aponeurotomy and up to 3 times at 4 week intervals with collagenase injection.

Affected Dupuytren's cords will be treated with 1-3 collagenase clostridium histolyticum injections at 4 week intervals, based on clinical response of the contracture. Cords will be treated until motion of the joint is within 0-5 degrees of normal, for up to 3 total injections.

Percutaneous needle aponeurotomy will be performed using an 18 gauge needle. The needle is inserted through the skin into the Dupuytren's cord. The needle is moved very slowly through the cord until complete rupture of the cord is obtained.

Percutaneous needle aponeurotomy will be performed using an 18 gauge needle. The needle is inserted through the skin into the Dupuytren's cord. The needle is moved very slowly through the cord until complete rupture of the cord is obtained. Participant feedback is obtained throughout the procedure to prevent digital nerve or flexor tendon injury. Participants are asked to report Tinel's sign which indicates that the needle is in close proximity to the digital nerve and to report pain with needle advancement which indicates proximity to the flexor tendon.

Collagenase clostridium histolyticum will be used to treat participants in this arm of the study. Affected cords will be treated with 1-3 collagenase injections at 4 week intervals, based on clinical response of the contracture. Cords will be treated until motion of the joint is within 0-5 degrees of normal, for up to 3 total injections. Metacarpophalangeal cords will be injected with 0.58mg (10 000 units) of collagenase in 0.25ml of sterile diluent. Proximal interphalangeal cords will be injected with 0.58mg (10 000 units) of collagenase in 0.20ml of sterile diluent.

Collagenase clostridium histolyticum will be used to treat participants in this arm of the study. Affected cords will be treated with 1-3 collagenase injections at 4 week intervals, based on clinical response of the contracture. Cords will be treated until motion of the joint is within 0-5 degrees of normal, for up to 3 total injections.

Metacarpophalangeal cords will be injected with 0.58mg (10 000 units) of collagenase in 0.25ml of sterile diluent. Proximal interphalangeal cords will be injected with 0.58mg (10 000 units) of collagenase in 0.20ml of sterile diluent.

Collegenase injection

Percutaneous needle aponeurotomy will be performed using an 18 gauge needle. The needle is inserted through the skin into the Dupuytren's cord. The needle is moved very slowly through the cord until complete rupture of the cord is obtained.

Needle aponeurotomy

Michael Morhart, MD MSc

Dupuytren's disease results in deformity of the hand and this can lead to trouble with daily activities. Treatment traditionally involves cutting out diseased tissue, however this can cause damage to important structures in the hand and results in large scars.

Needle aponeurotomy and collagenase injections are newer treatments that are thought to be safer. These treatments allow quicker return to function. One drawback is that Dupuytren's deformity may return more quickly than when all diseased tissue is surgically cut out.

This research study is designed to compare the effectiveness of needle aponeurotomy and collagenase injection for Dupuytren's disease. This study will determine which procedure gives the best results- either needle aponeurotomy, collagenase injection, or both procedures in combination. Participants will be evaluated to see how they do in the long term.

Dupuytren's disease is a benign proliferative disorder of the palmar fascia. It results in progressive thickening and contracture of fibrous bands on the volar surface of the palm and fingers as a result of excessive myofibroblast activity. Patients develop longitudinal cords which may lead to progressive joint contractures. Dupuytren's disease limits hand function and can diminish quality of life.

The most commonly used technique for treatment is open limited fasciectomy. The cumulative complication rate ranges from 14-67% and includes nerve division (2-5%), infection (4-12%), neurapraxia (0.4-52%), and regional pain syndrome (2-13%). The recurrence rate of Dupuytren's disease after fasciectomy is approximately 50% at 5 years.

Recently, interest in needle aponeurotomy and collagenase clostridium histolyticum injection have increased as alternative treatment modalities for Dupuytren's disease. Both procedures can be performed in an outpatient clinic, have limited downtime, allow earlier return to work, and are associated with significantly fewer serious complications than open fasciectomy. Needle aponeurotomy and collagenase injection are less invasive than fasciectomy, however they are associated with higher rates of disease recurrence.

Numerous studies investigating the effectiveness and safety of needle aponeurotomy and collagenase injection studies have been published. To date, there is no published literature about the use of these techniques in combination for the treatment of Dupuytren's disease. The investigators propose to follow the patient population of a single surgeon performing needle aponeurotomy in combination with collagenase injection to determine the effectiveness of this combination treatment. Patients treated with combination treatment will be compared to patients treated with a single modality- either needle aponeurotomy or collagenase injection.

Patients will be assessed pre and post operatively to evaluate functional status and the degree of joint contracture. Patient satisfaction, adverse events, recurrence, and repeat treatment rates will also be determined.

Collagenase and Needle Aponeurotomy: Single Modality Versus Combination Treatment for Dupuytren's Disease

The degree of the participant's Dupuytren's disease joint contracture after treatment will be measured by a physical therapist at each of the participant's follow up appointments.

The participant's range of motion in their joint affected by Dupuytren's disease will be measured by a physical therapist prior to treatment and following treatment at each of the participant's follow up appointments.

University of Alberta

Symptoms and General Pathology

Arthritis

Rare Diseases

collagenase

Lawrence C. Hurst

OBJECTIVES: I. Compare the safety and efficacy of clostridial collagenase vs placebo in terms of improving the degree of flexion deformity, range of finger motion, and grip strength in patients with residual stage Dupuytren's disease.

II. Compare the overall clinical success rate, time to return to normal finger contracture to within 0-5 degrees of normal (zero degrees), and frequency of cord rupture in the joint of patients treated with these regimens.

III. Compare the baseline change in degree of finger flexion deformity, range of motion of the treated finger, and strength of hand grip (in pounds) in patients treated with these regimens.

IV. Compare the frequency distribution of the number of patients with reduction in finger contracture to within 0-5 degrees of normal (zero degrees) and the number who require re-treatment with open-label collagenase after treatment with these regimens.

PROTOCOL OUTLINE: This is a randomized, investigator-blinded, placebo-controlled, multicenter study. Patients are randomized to one of two treatment arms.

Arm I: Patients receive a single collagenase injection into the target finger cord on day 0.

Arm II: Patients receive a single placebo injection as in arm I.

Both arms: After the 1 month evaluation, patients who are unresponsive to treatment may receive monthly injections of collagenase for a maximum of 5 injections.

Beginning at 1 day after completion of treatment, patients use a joint nighttime extension splint for 4 months and perform finger flexion/extension exercises.

Patients are followed at 1, 7, and 14 days, monthly for 3 months, every 3 months for 9 months, and then annually for 4 years.

Completion date provided represents the completion date of the grant per OOPD records

Phase III Randomized Study of Collagenase in Patients With Residual Stage Dupuytren's Disease

State University of New York

OBJECTIVES:

Evaluate the safety and efficacy of collagenase in improving flexion deformity, range of motion, and grip strength in patients with residual Dupuytren's disease.

PROTOCOL OUTLINE: This is a randomized, investigator-blinded, placebo-controlled study.

Patients receive a single dose of either collagenase or placebo into the target finger on day 0. Patients who do not respond at the 1 month follow up visit may receive an injection of open label collagenase, if IgE antibody levels are no greater than 15 ng/mL.

Following treatment, patients use a nighttime extension splint for 4 months and perform finger flexion/extension exercises. Patients are followed at 1, 7, and 14 days, and at 1, 2, 3, 6, 9, and 12 months, for each joint treated.

Completion date provided represents the completion date of the grant per OOPD records

Phase II Randomized Study of Collagenase in Patients With Residual Type Dupuytren's Disease

Pain

Patients who choose to undergo percutaneous needle aponeurotomy (PNA) for primary treatment of Dupuytren's disease

Patients who choose to receive Collagenase clostridium histolyticum injection (drug name Xiaflex) for primary treatment of Dupuytren's disease.

Percutaneous Needle Aponeurotomy

Xiaflex injection into palpable cords (day 0), physical manipulation (day 7)

Collagenase clostridium histolyticum

Catherine McMillan, MSc

Paul A. Binhammer, MD, MSc

This study will evaluate short-term pain and function associated with percutaneous needle aponeurotomy (PNA) and injections of the enzyme collagenase clostridium histolyticum in patients with Dupuytren's disease. Scores on outcome measures will be compared between groups to determine whether treatments differ in terms of hand function and pain during the early post-treatment period.

Percutaneous needle aponeurotomy (PNA) and injections of the enzyme collagenase clostridium histolyticum are two non-invasive treatment options for patients with Dupuytren's disease. While PNA has been offered for decades, injectable collagenase is relatively new. The effectiveness of each treatment has been compared in the literature; however, recovery, in terms of pain and short-term function has not been formally evaluated. The objective of this study is to objectively compare short-term function and pain outcomes associated with each of these two procedures in patients presenting with untreated Dupuytren's disease.

Short-term Function and Pain After Treatment for Dupuytren's Disease

Comparing Short-term Function and Pain After Treatment With Collagenase Clostridium Histolyticum or Percutaneous Needle Aponeurotomy for Dupuytren's Disease

A validated patient-reported 12-item questionnaire pertaining to several aspects of hand function that is answered on 1 through 5 Likert scales. Higher scores indicate better hand function.

The URAM is a validated patient-reported 9-item functional assessment scale used clinically and for research purposes specific to patients with Dupuytren's disease. The resulting score quantifies Dupuytren's disease-related disability, with higher scores indicating higher level of disability.

An emailed form asking participants to rate pain and function during the past 24 hours using two 1-5 Likert scales. Two additional questions to assess night splint compliance and pain medication (yes/no)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Collagenase and Needle Aponeurotomy: Single Modality Versus Combination Treatment for Dupuytren's Disease	NCT01776892	Dupuytren Contr...	Collegenase inj... Needle aponeuro...	18 Years -	University of Alberta
Collagenase and Needle Aponeurotomy: Single Modality Versus Combination Treatment for Dupuytren's Disease	NCT01776892	Dupuytren Contr...	Collegenase inj... Needle aponeuro...	18 Years -	University of Alberta
Phase III Randomized Study of Collagenase in Patients With Residual Stage Dupuytren's Disease	NCT00014742	Dupuytren's Con...	collagenase	18 Years -	FDA Office of Orphan Products Development
Phase II Randomized Study of Collagenase in Patients With Residual Type Dupuytren's Disease	NCT00004409	Dupuytren's Con...	collagenase	18 Years -	FDA Office of Orphan Products Development
Short-term Function and Pain After Treatment for Dupuytren's Disease	NCT02301078	Dupuytren Disea...	Percutaneous Ne... Collagenase clo...	18 Years -	Sunnybrook Health Sciences Centre
Phase III Randomized Study of Collagenase in Patients With Residual Stage Dupuytren's Disease	NCT00014742	Dupuytren's Con...	collagenase	18 Years -	FDA Office of Orphan Products Development

Spots Global Cancer Trial Database for collagenase

Every month we try and update this database with for collagenase cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for collagenase

Every month we try and update this database with for collagenase cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for collagenase cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.