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Safety and Efficacy of Delayed Manipulation After Xiaflex Treatment in Subjects With Dupuytren's Contracture

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ClinicalTrials.gov Identifier: NCT01226121
Recruitment Status : Terminated (difficulty enrolling additional patients)
First Posted : October 21, 2010
Results First Posted : June 16, 2014
Last Update Posted : June 16, 2014
Sponsor:
Collaborator:
Stony Brook University
Information provided by (Responsible Party):
F. Thomas D. Kaplan, MD, Indiana Hand to Shoulder Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Dupuytren's Disease
Intervention Biological: Clostridial collagenase injectable
Enrollment 37
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Day 1 Manipulation Day 2 Manipulation Day 4 Manipulation
Hide Arm/Group Description Finger manipulation one day following collagenase injection Finger manipulation two days following collagenase injection Finger manipulation four days following collagenase injection
Period Title: Overall Study
Started 13 11 13
30 Day Evaluation 12 11 13
Completed 11 11 12
Not Completed 2 0 1
Reason Not Completed
Lost to Follow-up             2             0             1
Arm/Group Title Day 1 Manipulation Day 2 Manipulation Day 4 Manipulation Total
Hide Arm/Group Description Finger manipulation one day following collagenase injection Finger manipulation two days following collagenase injection Finger manipulation four days following collagenase injection Total of all reporting groups
Overall Number of Baseline Participants 13 11 13 37
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 11 participants 13 participants 37 participants
63.9  (10.3) 67  (6.4) 65.5  (10.2) 65.44  (9.02)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 11 participants 13 participants 37 participants
Female
0
   0.0%
2
  18.2%
1
   7.7%
3
   8.1%
Male
13
 100.0%
9
  81.8%
12
  92.3%
34
  91.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants 11 participants 13 participants 37 participants
13 11 13 37
1.Primary Outcome
Title Percentage of Patients With Clinical Improvement (> 50% Reduction in Contracture)
Hide Description [Not Specified]
Time Frame 30 days after injection
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Day 1 Manipulation Day 2 Manipulation Day 4 Manipulation
Hide Arm/Group Description:
Finger manipulation one day following collagenase injection
Finger manipulation two days following collagenase injection
Finger manipulation four days following collagenase injection
Overall Number of Participants Analyzed 12 11 13
Measure Type: Number
Unit of Measure: percentage of participants
92 91 85
2.Secondary Outcome
Title Percentage of Patients Obtaining Clinical Success at 90 Days (<=5 Degree Residual Contracture)
Hide Description [Not Specified]
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Day 1 Manipulation Day 2 Manipulation Day 4 Manipulation
Hide Arm/Group Description:
Finger manipulation one day following collagenase injection
Finger manipulation two days following collagenase injection
Finger manipulation four days following collagenase injection
Overall Number of Participants Analyzed 11 11 12
Measure Type: Number
Unit of Measure: percentage of patients
91 82 83
Time Frame data collected for 90 day period patients were followed following injection
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Day 1 Manipulation Day 2 Manipulation Day 4 Manipulation
Hide Arm/Group Description Finger manipulation one day following collagenase injection Finger manipulation two days following collagenase injection Finger manipulation four days following collagenase injection
All-Cause Mortality
Day 1 Manipulation Day 2 Manipulation Day 4 Manipulation
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Day 1 Manipulation Day 2 Manipulation Day 4 Manipulation
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/11 (0.00%)   0/13 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Day 1 Manipulation Day 2 Manipulation Day 4 Manipulation
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   13/13 (100.00%)   11/11 (100.00%)   13/13 (100.00%) 
Blood and lymphatic system disorders       
Lymphadenopathy  1  3/13 (23.08%)  2/11 (18.18%)  0/13 (0.00%) 
Nervous system disorders       
Pain  1  1/13 (7.69%)  5/11 (45.45%)  5/13 (38.46%) 
Skin and subcutaneous tissue disorders       
Edema  1  13/13 (100.00%)  9/11 (81.82%)  10/13 (76.92%) 
Bruising  1  9/13 (69.23%)  8/11 (72.73%)  9/13 (69.23%) 
Blister  1  3/13 (23.08%)  0/11 (0.00%)  2/13 (15.38%) 
Skin tear  1  2/13 (15.38%)  2/11 (18.18%)  0/13 (0.00%) 
pruritis  1  1/13 (7.69%)  3/11 (27.27%)  1/13 (7.69%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
Study was terminated early due to slow enrollment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: F. Thomas D. Kaplan
Organization: Indiana Hand to Shoulder Center
Phone: 3178759105
EMail: tdk@hand.md
Layout table for additonal information
Responsible Party: F. Thomas D. Kaplan, MD, Indiana Hand to Shoulder Center
ClinicalTrials.gov Identifier: NCT01226121     History of Changes
Other Study ID Numbers: IHtSC-Delay 101
First Submitted: October 20, 2010
First Posted: October 21, 2010
Results First Submitted: April 21, 2014
Results First Posted: June 16, 2014
Last Update Posted: June 16, 2014