CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 22 enrolled
Drug / intervention
collagenase injection +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02725528
NCT02725528Phase 3Completed
CompareCT.gov

A Multi-Center, Randomized Controlled Trial Comparing The Clinical Effectiveness and Cost-Effectiveness of Collagenase Injection (Xiaflex) and Palmar Fasciectomy in the Management of Dupuytren's Disease

McMaster University·interventional·Posted Apr 1, 2016·Updated Jul 18, 2023

In Brief

A Phase 3 clinical trial evaluating collagenase injection and limited palmar fasciectomy for Dupuytren's Disease. Completed, enrolled 22 participants across 10 sites.

Detailed Summary

This is a prospective, multi-centre, pragmatic randomized controlled trial to compare both the clinical effectiveness and cost-effectiveness of collagenase injections (CI) versus limited palmar fasciectomy (LPF) to determine if collagenase is a superior treatment in terms of improved quality of life and reducing recurrence of the disease without serious complications. Since collagenase injections are costly it is also important to know if this novel intervention is cost-effective from the patient, Ministry of Health and societal perspectives.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDupuytren's Disease
CountriesCanada
CollaboratorsThe Physicians' Services Incorporated Foundation

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 1, 2016
Enrollment StartJul 8, 2017
Primary CompletionDec 17, 2021
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 10.3 years ago

Interventions

collagenase injectiondrug

injection

limited palmar fasciectomyprocedure

surgery