Safety and Efficacy of Delayed Manipulation After Xiaflex Treatment in Subjects With Dupuytren's Contracture
This study is currently recruiting participants.
Verified September 2012 by Indiana Hand to Shoulder Center
Sponsor:
Indiana Hand to Shoulder Center
Collaborator:
Stony Brook University
Information provided by (Responsible Party):
F. Thomas D. Kaplan, MD, Indiana Hand to Shoulder Center
ClinicalTrials.gov Identifier:
NCT01226121
First received: October 20, 2010
Last updated: September 11, 2012
Last verified: September 2012
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Purpose
The purpose of this study is to determine if of manipulation of digits following collagenase injection for treatment of Dupuytren's contracture is effected by the amount of time between injection and manipulation.
| Condition | Intervention | Phase |
|---|---|---|
|
Dupuytren's Disease |
Biological: Clostridial collagenase injectable |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Post Market, Open-Label Study of the Safety and Efficacy of Delayed Manipulation After Xiaflex Treatment in Subjects With Dupuytren's Contracture |
Resource links provided by NLM:
Further study details as provided by Indiana Hand to Shoulder Center:
Primary Outcome Measures:
- Percentage of clinical improvement (> 50% reduction in contracture) [ Time Frame: 30 days after injection ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Digit range of motion [ Time Frame: 90 days ] [ Designated as safety issue: No ]
- Michigan Hand Questionaire [ Time Frame: 90 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | December 2010 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Day 1 manipulation
Finger manipulation one day following collagenase injection
|
Biological: Clostridial collagenase injectable
Finger manipulation performed 1, 2, or 4 days following collagenase injection
|
|
Active Comparator: Day 2 manipulation
Finger manipulation two days following collagenase injection
|
Biological: Clostridial collagenase injectable
Finger manipulation performed 1, 2, or 4 days following collagenase injection
|
|
Active Comparator: Day 4 manipulation
Finger manipulation four days following collagenase injection
|
Biological: Clostridial collagenase injectable
Finger manipulation performed 1, 2, or 4 days following collagenase injection
|
Detailed Description:
Patients with Metacarpophalangeal joint contractures caused by Dupuytren's disease will be evaluated as to the timing of the finger manipulation procedure that is performed following collagenase injection. Three groups will be evaluated: group 1 will have the manipulation procedure on the day following collagenase injection, group 2 will have the manipulation procedure on the second day following collagenase injection,and group 3 will have the manipulation procedure on the fourth day following collagenase injection,
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Adult subjects (> 18 years) of either gender with an MP joint contracture and a palpable cord of > 20 degrees of a digit (excluding the thumb) due to Dupuytren's contracture
Exclusion Criteria:
- Any subject who has had prior surgical, percutaneous needle aponeurotomy or Xiaflex treatment for Dupuytren's contracture.
- Any subject using anti-coagulant therapy other than low dose aspirin (up to 150mg/day).
- Any subject in the opinion of the MD investigators with chronic, severe or terminal medical illness which would make them unsuitable for study participation.
- Any subject with known allergy to Xiaflex (Clostridial collagenase).
- Any subject who cannot conform to the study visit schedule
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01226121
Locations
| United States, Indiana | |
| Indiana Hand to Shoulder Center | Recruiting |
| Indianaplis, Indiana, United States, 46260 | |
| Contact: Suzanne Cornelius, PA-C 317-875-9105 | |
| Contact: F. Thomas D. Kaplan, MD 317-875-9105 | |
| Principal Investigator: F. Thomas D. Kaplan, MD | |
| Sub-Investigator: Gregory A Merrell, MD | |
| United States, New York | |
| Stony Brook University | Not yet recruiting |
| Stony Brook, New York, United States, 11794 | |
| Contact: Marie A Badalamente, PhD 631-632-6000 | |
| Principal Investigator: Lawrence C Hurst, MD | |
| Sub-Investigator: Marie A Badalamente, PhD | |
Sponsors and Collaborators
Indiana Hand to Shoulder Center
Stony Brook University
Investigators
| Principal Investigator: | F. Thomas D. Kaplan, MD | Indiana Hand to Shoulder Center |
| Principal Investigator: | Lawrence C Hurst, MD | Stony Brook University |
More Information
Publications:
| Responsible Party: | F. Thomas D. Kaplan, MD, MD, Indiana Hand to Shoulder Center |
| ClinicalTrials.gov Identifier: | NCT01226121 History of Changes |
| Other Study ID Numbers: | IHtSC-Delay 101 |
| Study First Received: | October 20, 2010 |
| Last Updated: | September 11, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Indiana Hand to Shoulder Center:
|
dupuytren dupuytren's |
Additional relevant MeSH terms:
|
Contracture Dupuytren Contracture Joint Diseases |
Musculoskeletal Diseases Muscular Diseases Connective Tissue Diseases |
ClinicalTrials.gov processed this record on May 23, 2013