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This study will evaluate the efficacy and safety of clostridial collagenase injections for treatment of Dupuytren's contracture of the thumb and first web space. The investigators hypothesis is that clostridial collagenase will have safety not significantly different to that demonstrated in Phase III clinical trials, and will be effective in significantly reducing the degree of thumb contracture.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Injectable clostridial collagenase | Experimental | Patients with thumb 1st web contracture secondary to Dupuytren's disease will be treated with 0.58mg of collagenase |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Injectable clostridial collagenase | Biological | Injection of 0.58mg clostridial collagenase into Dupuytren's cord, up to three injections |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number Patients Obtaining Clinical Improvement (>50% Reduction in Contracture) | 30 days after last injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana Hand to Shoulder Center | Indianaplis | Indiana | 46260 | United States |
| 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Injectable Clostridial Collagenase | Patients were treated with 0.58 mg clostridial collagenase into palpable cord in 1st webspace |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Injectable Clostridial Collagenase | Patients were treated with 0.58 mg clostridial collagenase into palpable cord in 1st webspace |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Number Patients Obtaining Clinical Improvement (>50% Reduction in Contracture) | Posted | Number | participants | 30 days after last injection |
|
|
Day 1 after injection to Day 30
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Injectable Clostridial Collagenase | Patients were treated with 0.58 mg clostridial collagenase into palpable cord in 1st webspace |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ecchymosis | Skin and subcutaneous tissue disorders |
1 patient was seen at Day 10, but not at day 30. At Day 10, patient met the primary endpoint
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| F. Thomas D. Kaplan | Indiana Hand to Shoulder Center | 317-875-9105 | tdk@hand.md |
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| ID | Term |
|---|---|
| D004387 | Dupuytren Contracture |
| ID | Term |
|---|---|
| D005350 | Fibroma |
| D018218 | Neoplasms, Fibrous Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
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| ID | Term |
|---|---|
| D003012 | Microbial Collagenase |
| ID | Term |
|---|---|
| D017364 | Collagenases |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 0 |
| 7 |
| 7 |
| 7 |
| Edema | Skin and subcutaneous tissue disorders |
|
| Pruritis | Skin and subcutaneous tissue disorders |
|
| Paresthesia | Nervous system disorders |
|
| nausea | Gastrointestinal disorders |
|
| Skin Tear | Skin and subcutaneous tissue disorders |
|
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| 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 |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |