Not provided
Not provided
Not provided
Not provided
Not provided
difficulty enrolling additional patients
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Stony Brook University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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,
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Day 1 manipulation | Active Comparator | Finger manipulation one day following Clostridial collagenase injectable |
|
| Day 2 manipulation | Active Comparator | Finger manipulation two days following Clostridial collagenase injectable |
|
| Day 4 manipulation | Active Comparator | Finger manipulation four days following Clostridial collagenase injectable |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clostridial collagenase injectable | Biological | Finger manipulation performed 1, 2, or 4 days following collagenase injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Clinical Improvement (> 50% Reduction in Contracture) | 30 days after injection |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Obtaining Clinical Success at 90 Days (<=5 Degree Residual Contracture) | 90 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| F. Thomas D. Kaplan, MD | Indiana Hand to Shoulder Center | Principal Investigator |
| Lawrence C Hurst, MD | Stony Brook University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana Hand to Shoulder Center | Indianaplis | Indiana | 46260 | United States | ||
| Stony Brook University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19726771 | Background | Hurst LC, Badalamente MA, Hentz VR, Hotchkiss RN, Kaplan FT, Meals RA, Smith TM, Rodzvilla J; CORD I Study Group. Injectable collagenase clostridium histolyticum for Dupuytren's contracture. N Engl J Med. 2009 Sep 3;361(10):968-79. doi: 10.1056/NEJMoa0810866. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Day 1 Manipulation | Finger manipulation one day following collagenase injection |
| FG001 | Day 2 Manipulation | Finger manipulation two days following collagenase injection |
| FG002 | Day 4 Manipulation | Finger manipulation four days following collagenase injection |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Day 1 Manipulation | Finger manipulation one day following collagenase injection |
| BG001 | Day 2 Manipulation | Finger manipulation two days following collagenase injection |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Patients With Clinical Improvement (> 50% Reduction in Contracture) | Posted | Number | percentage of participants | 30 days after injection |
|
data collected for 90 day period patients were followed following injection
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Day 1 Manipulation | Finger manipulation one day following collagenase injection |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Edema | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
Study was terminated early due to slow enrollment
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| F. Thomas D. Kaplan | Indiana Hand to Shoulder Center | 3178759105 | tdk@hand.md |
Not provided
| ID | Term |
|---|---|
| D004387 | Dupuytren Contracture |
| ID | Term |
|---|---|
| D005350 | Fibroma |
| D018218 | Neoplasms, Fibrous Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Stony Brook |
| New York |
| 11794 |
| United States |
| BG002 | Day 4 Manipulation | Finger manipulation four days following collagenase injection |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Percentage of Patients Obtaining Clinical Success at 90 Days (<=5 Degree Residual Contracture) | Posted | Number | percentage of patients | 90 days |
|
|
|
| 0 |
| 13 |
| 13 |
| 13 |
| EG001 | Day 2 Manipulation | Finger manipulation two days following collagenase injection | 0 | 11 | 11 | 11 |
| EG002 | Day 4 Manipulation | Finger manipulation four days following collagenase injection | 0 | 13 | 13 | 13 |
| Bruising | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pain | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Skin tear | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| pruritis | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
Not provided
Not provided
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D003286 | Contracture |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |