Dupuytren's Contracture Clinical Trial
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
;
Allocation: Randomized, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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