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Enzyme

Collagenase and needle aponeurotomy for Dupuytren's Contracture

Phase 3

Waitlist Available

Led By Michael Morhart, MD MSc

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years post treatment

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Pivotal Trial

Summary

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.

Eligible Conditions

Dupuytren's Contracture

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years post treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years post treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years post treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Degree of joint contracture post treatment

Secondary study objectives

Change in joint range of motion

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Collagenase and needle aponeurotomyExperimental Treatment2 Interventions

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.

Group II: Needle aponeurotomyActive Control1 Intervention

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.

Group III: Collagenase injectionActive Control1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Needle aponeurotomy

2013

Completed Phase 4

~80

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