Efficacy and Safety of Xiaflex Injection for Treatment of Dupuytren's Contracture of the Thumb

• Sponsor: Indiana Hand to Shoulder Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01265420
• Collaborator: (none)
• Enrollment: 7
• Location: 1
• Arm: 1
• Duration (Months): 38
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dupuytren's Contracture	Biological: Injectable clostridial collagenase	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 7 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Efficacy and Safety of Xiaflex Injections for the Treatment of Thumb Cords in Dupuytren's Contractures
• Study Start Date: Dec 1, 2010
• Actual Primary Completion Date: Feb 1, 2014
• Actual Study Completion Date: Feb 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Injectable clostridial collagenase Patients with thumb 1st web contracture secondary to Dupuytren's disease will be treated with 0.58mg of collagenase	Biological: Injectable clostridial collagenase; Injection of 0.58mg clostridial collagenase into Dupuytren's cord, up to three injections; Other Names: Xiaflex

Outcome Measures

Primary Outcome Measures

1. Number Patients Obtaining Clinical Improvement (>50% Reduction in Contracture) [30 days after last injection]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Indiana Hand to Shoulder Center	Indianaplis	Indiana	United States	46260

Sponsors and Collaborators

• Indiana Hand to Shoulder Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: F. Thomas D. Kaplan, MD, MD, Indiana Hand to Shoulder Center
• ClinicalTrials.gov Identifier: NCT01265420
• Other Study ID Numbers: IHtSC-Thumb 101
• First Posted: Dec 23, 2010
• Last Update Posted: Apr 30, 2015
• Last Verified: Apr 1, 2015

• Keywords provided by F. Thomas D. Kaplan, MD, MD, Indiana Hand to Shoulder Center: Dupuytren; Dupuytren's Disease
• Additional relevant MeSH terms: Dupuytren Contracture; Contracture

Study Results

Participant Flow

Arm/Group Title	Injectable Clostridial Collagenase
Arm/Group Description	Patients were treated with 0.58 mg clostridial collagenase into palpable cord in 1st webspace
Period Title: Overall Study
STARTED	7
COMPLETED	6
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Injectable Clostridial Collagenase
Arm/Group Description	Patients were treated with 0.58 mg clostridial collagenase into palpable cord in 1st webspace
Overall Participants	7
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	62
Sex: Female, Male (Count of Participants)
Female	2 28.6%
Male	5 71.4%
Region of Enrollment (participants) [Number]
United States	7 100%

Outcome Measures

1. Primary Outcome

Title	Number Patients Obtaining Clinical Improvement (>50% Reduction in Contracture)
Time Frame	30 days after last injection

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Injectable Clostridial Collagenase
Arm/Group Description	Patients were treated with 0.58 mg clostridial collagenase into palpable cord in 1st webspace
Measure Participants	6
>50% reduction in contracture	5 71.4%
<50% reduction in contracture	1 14.3%

Adverse Events

Time Frame	Day 1 after injection to Day 30
Arm/Group Title	Injectable Clostridial Collagenase
Arm/Group Description	Patients were treated with 0.58 mg clostridial collagenase into palpable cord in 1st webspace
All Cause Mortality
	Injectable Clostridial Collagenase
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Injectable Clostridial Collagenase
	Affected / at Risk (%)	# Events
Total	0/7 (0%)
Other (Not Including Serious) Adverse Events
	Injectable Clostridial Collagenase
	Affected / at Risk (%)	# Events
Total	7/7 (100%)
Gastrointestinal disorders
nausea	1/7 (14.3%)
Nervous system disorders
Paresthesia	1/7 (14.3%)
Skin and subcutaneous tissue disorders
Ecchymosis	7/7 (100%)
Edema	7/7 (100%)
Pruritis	1/7 (14.3%)
Skin Tear	1/7 (14.3%)

Limitations/Caveats

1 patient was seen at Day 10, but not at day 30. At Day 10, patient met the primary endpoint

More Information

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.