Trial Outcomes & Findings for Safety and Efficacy of Delayed Manipulation After Xiaflex Treatment in Subjects With Dupuytren's Contracture (NCT NCT01226121)
NCT ID: NCT01226121
Last Updated: 2014-06-16
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
37 participants
Primary outcome timeframe
30 days after injection
Results posted on
2014-06-16
Participant Flow
Participant milestones
| Measure |
Day 1 Manipulation
Finger manipulation one day following collagenase injection
|
Day 2 Manipulation
Finger manipulation two days following collagenase injection
|
Day 4 Manipulation
Finger manipulation four days following collagenase injection
|
|---|---|---|---|
|
Overall Study
30 Day Evaluation
|
12
|
11
|
13
|
|
Overall Study
COMPLETED
|
11
|
11
|
12
|
|
Overall Study
STARTED
|
13
|
11
|
13
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
1
|
Reasons for withdrawal
| Measure |
Day 1 Manipulation
Finger manipulation one day following collagenase injection
|
Day 2 Manipulation
Finger manipulation two days following collagenase injection
|
Day 4 Manipulation
Finger manipulation four days following collagenase injection
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
1
|
Baseline Characteristics
Safety and Efficacy of Delayed Manipulation After Xiaflex Treatment in Subjects With Dupuytren's Contracture
Baseline characteristics by cohort
| Measure |
Day 1 Manipulation
n=13 Participants
Finger manipulation one day following collagenase injection
|
Day 2 Manipulation
n=11 Participants
Finger manipulation two days following collagenase injection
|
Day 4 Manipulation
n=13 Participants
Finger manipulation four days following collagenase injection
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63.9 years
STANDARD_DEVIATION 10.3 • n=99 Participants
|
67 years
STANDARD_DEVIATION 6.4 • n=107 Participants
|
65.5 years
STANDARD_DEVIATION 10.2 • n=206 Participants
|
65.44 years
STANDARD_DEVIATION 9.02 • n=7 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
34 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=99 Participants
|
11 participants
n=107 Participants
|
13 participants
n=206 Participants
|
37 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 30 days after injectionOutcome measures
| Measure |
Day 1 Manipulation
n=12 Participants
Finger manipulation one day following collagenase injection
|
Day 2 Manipulation
n=11 Participants
Finger manipulation two days following collagenase injection
|
Day 4 Manipulation
n=13 Participants
Finger manipulation four days following collagenase injection
|
|---|---|---|---|
|
Percentage of Patients With Clinical Improvement (> 50% Reduction in Contracture)
|
92 percentage of participants
|
91 percentage of participants
|
85 percentage of participants
|
SECONDARY outcome
Timeframe: 90 daysOutcome measures
| Measure |
Day 1 Manipulation
n=11 Participants
Finger manipulation one day following collagenase injection
|
Day 2 Manipulation
n=11 Participants
Finger manipulation two days following collagenase injection
|
Day 4 Manipulation
n=12 Participants
Finger manipulation four days following collagenase injection
|
|---|---|---|---|
|
Percentage of Patients Obtaining Clinical Success at 90 Days (<=5 Degree Residual Contracture)
|
91 percentage of patients
|
82 percentage of patients
|
83 percentage of patients
|
Adverse Events
Day 1 Manipulation
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Day 2 Manipulation
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Day 4 Manipulation
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Day 1 Manipulation
n=13 participants at risk
Finger manipulation one day following collagenase injection
|
Day 2 Manipulation
n=11 participants at risk
Finger manipulation two days following collagenase injection
|
Day 4 Manipulation
n=13 participants at risk
Finger manipulation four days following collagenase injection
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Edema
|
100.0%
13/13 • data collected for 90 day period patients were followed following injection
|
81.8%
9/11 • data collected for 90 day period patients were followed following injection
|
76.9%
10/13 • data collected for 90 day period patients were followed following injection
|
|
Skin and subcutaneous tissue disorders
Bruising
|
69.2%
9/13 • data collected for 90 day period patients were followed following injection
|
72.7%
8/11 • data collected for 90 day period patients were followed following injection
|
69.2%
9/13 • data collected for 90 day period patients were followed following injection
|
|
Nervous system disorders
Pain
|
7.7%
1/13 • data collected for 90 day period patients were followed following injection
|
45.5%
5/11 • data collected for 90 day period patients were followed following injection
|
38.5%
5/13 • data collected for 90 day period patients were followed following injection
|
|
Skin and subcutaneous tissue disorders
Blister
|
23.1%
3/13 • data collected for 90 day period patients were followed following injection
|
0.00%
0/11 • data collected for 90 day period patients were followed following injection
|
15.4%
2/13 • data collected for 90 day period patients were followed following injection
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
23.1%
3/13 • data collected for 90 day period patients were followed following injection
|
18.2%
2/11 • data collected for 90 day period patients were followed following injection
|
0.00%
0/13 • data collected for 90 day period patients were followed following injection
|
|
Skin and subcutaneous tissue disorders
Skin tear
|
15.4%
2/13 • data collected for 90 day period patients were followed following injection
|
18.2%
2/11 • data collected for 90 day period patients were followed following injection
|
0.00%
0/13 • data collected for 90 day period patients were followed following injection
|
|
Skin and subcutaneous tissue disorders
pruritis
|
7.7%
1/13 • data collected for 90 day period patients were followed following injection
|
27.3%
3/11 • data collected for 90 day period patients were followed following injection
|
7.7%
1/13 • data collected for 90 day period patients were followed following injection
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place