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Fasciectomy vs Collagenase Injection in Recurrent Dupuytren Disease

StatusActive, Not Recruiting
PhasePhase 4
Started2018-03-20
View on ClinicalTrials.gov ↗

Amendment history

2025-04-13
Study Status v8
Primary completion dateestimated 2024-09→confirmed 2024-09-01
2023-11-07
Study Status v7
Re-verified, no change to tracked fields
2022-10-24
Enrolling by Invitation→Active, Not Recruiting Study Status, Study Design v6
Trial statusEnrolling by Invitation→Active, Not Recruiting
Primary completion date2023-12→2024-09
Completion date2026-12→2027-09
Enrollment targetestimated 56→confirmed 60
2021-11-03
Study Status v5
Re-verified, no change to tracked fields
2020-10-29
Study Status, Study Description, Eligibility v4
Primary completion date2021-05-31→2023-12
Completion date2024-05-31→2026-12
Eligibility criteria-11 characters
[...] int in a finger previously treated with surgical fasciectomy or, collagenase injections, or needle fasciotomy. Palpable cord in the palm and/or affected finger causing the recurrent contracture. No surgerySurgery, collagenase injection or collagenaseneedle fasciotomy in the finger with recurrent contracture in the past 12 mon [...] nvolving the affected finger. More than 2 previous surgeries, collagenase injections or collagenaseneedle treatmentsfasciotomies in the affected finger. Previous treatment with both fasciectomy and collagenase in the affected finger. Examining surgeon deems further fasciec [...]
Study description+19 characters
[...] ne or more fingers after previous treatment with fasciectomy or, collagenase injection or needle fasciotomy, a passive extension deficit ≥30 degrees in the metacarpoph [...]
Show 3 earlier versions
2019-09-10
Study Status v3
Re-verified, no change to tracked fields
2018-04-04
Study Status v2
Start dateestimated 2018-02-15→confirmed 2018-03-20
2018-01-26
Study Status, Oversight, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v1
Primary completion date2020-01-31→2021-05-31
Completion date2023-01-31→2024-05-31
Start date2018-02-01→2018-02-15
Enrollment target52→56
InterventionsCollagenase (Drug), Fasciectomy (Procedure)→Collagenase Clostridium Histolyticum (Drug), Fasciectomy (Procedure)
Eligibility criteria+114 characters
[...] scular injury in the affected finger. Osteoarthritis in the MCPmetacarpophalangeal and/or PIPproximal interphalangeal joint joint in the affected finger Complications after the previous treatment, such as infection or complex regional pain syndrome (CRPS). Previous trauma or other surgery involving the affected fi [...] th both fasciectomy and collagenase in the affected finger. FurtherExamining surgeon deems further fasciectomy inappropriate or potentially associated with ve [...] example in severe contracture and/or severe scarring after multiplethe previous surgeries, and considers salvage procedures (s [...] [...]
Secondary endpoints7 to 12 entries
11-item disabilities of the arm, shoulder and hand (QuickDASH) score URAM EuroQoL 5-dimensions (EQ-5D) Index Total active motion Total active extension deficit (metacarpophalangeal plus proximal interphalangeal joints) Proportion of patients with worsening in total active extension deficit ≥20 degrees Palmar pain score Cold intolerance symptom severity score Total passive extension deficit (metacar [...]
Study description+285 characters
At present, there is noNo definitive cure for Dupuytren disease (DD) currently exists and recurrence of finger contractures after treatment is co [...] edure is associated with a high incidence of complications. Injection of Collagenase injectionClostridium Histolyticum into Dypuytren cords causing the contracture is a non-surgical treatment option for Dupuytren diseaseDD and has been shown to be a safe and effective method, although most. Most studies regarding collagenase injection have involved first-time treatment. CollagenaseEfficacy efficacyof collagenase injection in patients with recurrent Du [...] [...]
2018-01-14
Original filing
Region Skane
146 trials monitored
See 5 trials at risk
This randomized controlled trial will compare the outcome of surgery (fasciectomy) with that of local injection of Collagenase Clostridium Histolyticum in patients with recurrent finger joint contracture after previous treatment with Surgery, collagenase injection or needle fasciotomy. Half of the participants will be treated with surgery while the other half will receive collagenase injection.
Trial Details
NCT Number NCT03406338
Lead Sponsor Region Skane
Conditions Dupuytren Disease of Finger
Enrollment 60 participants
Start Date 2018-03-20
Primary Completion 2024-09-01 (estimated)
Study Completion 2027-09 (estimated)
Updated on ClinicalTrials.gov 2025-04-16