Dupuytren's Contracture Clinical Trial
Official title:
The Effects of Steroid Injection With Percutaneous Needle Aponeurotomy in Patients With Dupuytren's Contracture: a Randomized Controlled Study
Background:
Dupuytren's contracture is a common hand problem that causes certain fingers to bend towards
the palm. Patients with this condition cannot perform daily activities and many are unable
to work. It is usually treated by an operation to straighten the fingers followed by therapy
if the angle that the fingers are bent at is large enough. However, no treatment has been
able to completely prevent the angle from persisting.
Objective:
This study is designed to examine whether or not the use of a drug in combination with
surgery will improve the angle at which the fingers are bent more than surgery alone.
Hypothesis:
Subjects who receive triamcinolone acetonide will have straighter fingers compared with
subjects who only have the operation and no triamcinolone acetonide at both 3 months and 6
months after the operation.
Methods:
Eligible patients interested in having the operation to treat Dupuytren's contracture will
be asked if they would like to join the study. Subjects will be randomly placed into one of
two groups: the steroid injection group or the control group. Subjects will have a
pre-operative visit, the surgery, and follow-ups at 6 weeks, 3 months and 6 months. All
subjects will have the operation, but only those in the steroid injection group will receive
an injection of the drug. During the 6 week and 3 month follow-ups, subjects in the steroid
injection group may receive another injection if their fingers are still bent. Angles are
measured at the pre-operative visit and at 3 and 6 months. The change in angle from before
to after and any differences in the groups, in time points and interactions between the two
will be analyzed.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01715467 -
CORRECT: COmmunity RegistRy Study Evaluating Dupuytren's Contracture Treatment
|
N/A | |
| Completed |
NCT01674634 -
Safety and Efficacy of Two Concurrent Injections of AA4500 in Adult Subjects With Multiple Dupuytren's Contractures
|
Phase 3 | |
| Completed |
NCT01407068 -
Administration of Two Injections for Multiple Dupuytren's Contractures
|
Phase 3 | |
| Completed |
NCT00528931 -
A Pharmacokinetic Study of AA4500 (XIAFLEX™, Proposed Name) in Subjects With Dupuytren's Contracture
|
Phase 1 | |
| Completed |
NCT01588353 -
Collagenase Option for Reduction of Dupuytren's Contracture in Japan
|
Phase 3 | |
| Completed |
NCT00468949 -
Health-Related Quality of Life in Patients With Dupuytren's Disease
|
Phase 1 | |
| Completed |
NCT01444729 -
Post Approval Commitment Study
|
N/A | |
| Terminated |
NCT05877066 -
Real-World Data Study to Understand Participant Treatment Outcomes for Dupuytren's Contracture
|
||
| Completed |
NCT01229436 -
Treatment Of Dupuytren's Contracture With Collagenase Clostridium Histolyticum Injection (Xiapex)
|
Phase 3 | |
| Completed |
NCT01265420 -
Efficacy and Safety of Xiaflex Injection for Treatment of Dupuytren's Contracture of the Thumb
|
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 |
NCT00004409 -
Phase II Randomized Study of Collagenase in Patients With Residual Type Dupuytren's Disease
|
Phase 2 | |
| Completed |
NCT00014742 -
Phase III Randomized Study of Collagenase in Patients With Residual Stage Dupuytren's Disease
|
Phase 3 |