Dupuytren's Contracture Clinical Trial
— GRASP-DCOfficial title:
Generating Real-world Ambispective Data to Study Participant Treatment Outcomes for Dupuytren's Contracture
NCT number | NCT05877066 |
Other study ID # | EP01REG |
Secondary ID | |
Status | Terminated |
Phase | |
First received | |
Last updated | |
Start date | June 14, 2023 |
Est. completion date | February 26, 2024 |
Verified date | April 2024 |
Source | Endo Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
This is an observational study, meaning participants will not receive any investigational treatment as part of this study. Researchers will collect real-world data (RWD), based on usual care, to gain a more in-depth knowledge of the natural history and the treatment outcomes of Dupuytren's Contracture (DC) to evaluate the management of DC.
Status | Terminated |
Enrollment | 130 |
Est. completion date | February 26, 2024 |
Est. primary completion date | February 26, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Key Inclusion Criteria: - Any adult with a confirmed clinical diagnosis of DC. - Age 18 years (or age of majority in their jurisdiction) or older at time of enrollment. - Willing to participate in the registry (including completion of ePROs) and complete the informed consent form. - Having received DC treatment, either non-surgical or surgical, within 2 weeks before enrollment, at enrollment or any time after the date of enrollment or not having received DC treatment after confirmed diagnosis of DC. - Able to participate in English based registry. Key Exclusion criteria: - Not having a clinical diagnosis of DC. - Age less than 18 years. - Do not provide informed consent. |
Country | Name | City | State |
---|---|---|---|
United States | Endo Pharmaceuticals Clinical Site 3 | Bend | Oregon |
United States | Endo Pharmaceuticals Clinical Site 7 | Charlotte | North Carolina |
United States | Endo Pharmaceuticals Clinical Site 1 | Eatontown | New Jersey |
United States | Endo Pharmaceuticals Clinical Site 5 | Greenwich | Connecticut |
United States | Endo Pharmaceuticals Clinical Site 2 | Indianapolis | Indiana |
United States | Endo Pharmaceuticals Clinical Site 6 | Phoenix | Arizona |
United States | Endo Pharmaceuticals Clinical Site 4 | Temple Terrace | Florida |
Lead Sponsor | Collaborator |
---|---|
Endo Pharmaceuticals | Pulse InfoFrame |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants Receiving Each Treatment Type for DC | Up to 36 months | ||
Secondary | Change from Baseline in Michigan Hand Questionnaire (MHQ) Scale Score | Up to 36 months | ||
Secondary | Change from Baseline in European Quality of Life Five Dimension (EQ-5D) Questionnaire Score | Up to 36 months | ||
Secondary | Change from Baseline in Unité Rhumatologique des Affections de la Main (URAM) Scale Score | Up to 36 months | ||
Secondary | Participant Satisfaction Questionnaire | Up to 36 months | ||
Secondary | Number of Participants Receiving Post-Procedural Care by the Treating Physician | Up to 36 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01674634 -
Safety and Efficacy of Two Concurrent Injections of AA4500 in Adult Subjects With Multiple Dupuytren's Contractures
|
Phase 3 | |
Completed |
NCT01715467 -
CORRECT: COmmunity RegistRy Study Evaluating Dupuytren's Contracture Treatment
|
N/A | |
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 |
NCT00565019 -
Effects of Steroid Injection With Percutaneous Needle Aponeurotomy in Dupuytren's Contracture
|
Phase 3 | |
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 | |
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 |