Dupuytren's Contracture Clinical Trial
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
;
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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|
N/A | |
| Completed |
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|
Phase 3 | |
| Completed |
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|
Phase 3 | |
| Completed |
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|
Phase 1 | |
| Completed |
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|
Phase 3 | |
| Completed |
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| Completed |
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|
Phase 1 | |
| Completed |
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Post Approval Commitment Study
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N/A | |
| Terminated |
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Real-World Data Study to Understand Participant Treatment Outcomes for Dupuytren's Contracture
|
||
| Completed |
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|
Phase 3 | |
| Completed |
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|
Phase 4 | |
| Completed |
NCT00931567 -
Evaluation of the Efficiency of Autologous Platelet Gel (Platelet Rich Fibrin) Obtained From Own Patients' Blood Versus Vaselitulle in Dupuytren's Disease Postoperative Wound Healing
|
Phase 2/Phase 3 | |
| Completed |
NCT00528606 -
AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Dupuytren's Contracture
|
Phase 3 | |
| Completed |
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Phase III Randomized Study of Collagenase in Patients With Residual Stage Dupuytren's Disease
|
Phase 3 |