Dupuytren's Contracture
Conditions
Keywords
Dupuytren, Dupuytren's Disease
Brief summary
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.
Interventions
BIOLOGICALInjectable clostridial collagenase
Injection of 0.58mg clostridial collagenase into Dupuytren's cord, up to three injections
Sponsors
Indiana Hand to Shoulder Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adult subjects (\> 18 years) of either gender with an MP and/or IP joint contracture and a palpable cord of \> 20 degrees of the thumb * First web space contracture with a palpable cord due to Dupuytren's contracture
Exclusion criteria
* Prior surgical, percutaneous needle aponeurotomy or Xiaflex treatment for Dupuytren's contracture of the same thumb. * 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). * Pregnant or nursing female * Any subject who cannot conform to the study visit schedule
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number Patients Obtaining Clinical Improvement (>50% Reduction in Contracture) | 30 days after last injection |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Injectable Clostridial Collagenase Patients were treated with 0.58 mg clostridial collagenase into palpable cord in 1st webspace | 7 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Injectable Clostridial Collagenase |
|---|---|
| Age, Continuous | 62 years |
| Region of Enrollment United States | 7 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 7 / 7 |
| serious Total, serious adverse events | 0 / 7 |
Outcome results
Primary
Number Patients Obtaining Clinical Improvement (>50% Reduction in Contracture)
Time frame: 30 days after last injection
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Injectable Clostridial Collagenase | Number Patients Obtaining Clinical Improvement (>50% Reduction in Contracture) | >50% reduction in contracture | 5 participants |
| Injectable Clostridial Collagenase | Number Patients Obtaining Clinical Improvement (>50% Reduction in Contracture) | <50% reduction in contracture | 1 participants |