Dupuytren's Disease
Conditions
Keywords
dupuytren, dupuytren's
Brief summary
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.
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,
Interventions
BIOLOGICALClostridial collagenase injectable
Finger manipulation performed 1, 2, or 4 days following collagenase injection
Sponsors
Stony Brook University
Indiana Hand to Shoulder Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
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 metacarpophalangeal 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Patients With Clinical Improvement (> 50% Reduction in Contracture) | 30 days after injection |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Patients Obtaining Clinical Success at 90 Days (<=5 Degree Residual Contracture) | 90 days |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Day 1 Manipulation Finger manipulation one day following collagenase injection | 13 |
| Day 2 Manipulation Finger manipulation two days following collagenase injection | 11 |
| Day 4 Manipulation Finger manipulation four days following collagenase injection | 13 |
| Total | 37 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 0 | 1 |
Baseline characteristics
| Characteristic | Day 1 Manipulation | Day 2 Manipulation | Day 4 Manipulation | Total |
|---|---|---|---|---|
| Age, Continuous | 63.9 years STANDARD_DEVIATION 10.3 | 67 years STANDARD_DEVIATION 6.4 | 65.5 years STANDARD_DEVIATION 10.2 | 65.44 years STANDARD_DEVIATION 9.02 |
| Region of Enrollment United States | 13 participants | 11 participants | 13 participants | 37 participants |
| Sex: Female, Male Female | 0 Participants | 2 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Male | 13 Participants | 9 Participants | 12 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 13 / 13 | 11 / 11 | 13 / 13 |
| serious Total, serious adverse events | 0 / 13 | 0 / 11 | 0 / 13 |
Outcome results
Primary
Percentage of Patients With Clinical Improvement (> 50% Reduction in Contracture)
Time frame: 30 days after injection
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Day 1 Manipulation | Percentage of Patients With Clinical Improvement (> 50% Reduction in Contracture) | 92 percentage of participants |
| Day 2 Manipulation | Percentage of Patients With Clinical Improvement (> 50% Reduction in Contracture) | 91 percentage of participants |
| Day 4 Manipulation | Percentage of Patients With Clinical Improvement (> 50% Reduction in Contracture) | 85 percentage of participants |
Secondary
Percentage of Patients Obtaining Clinical Success at 90 Days (<=5 Degree Residual Contracture)
Time frame: 90 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Day 1 Manipulation | Percentage of Patients Obtaining Clinical Success at 90 Days (<=5 Degree Residual Contracture) | 91 percentage of patients |
| Day 2 Manipulation | Percentage of Patients Obtaining Clinical Success at 90 Days (<=5 Degree Residual Contracture) | 82 percentage of patients |
| Day 4 Manipulation | Percentage of Patients Obtaining Clinical Success at 90 Days (<=5 Degree Residual Contracture) | 83 percentage of patients |