Injectable Collagenase For Burns' Associated Contracture
Primary Purpose
Burn's Associated Contracture
Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Xiaflex (FDA approved collagenase)
Sponsored by
About this trial
This is an interventional treatment trial for Burn's Associated Contracture
Eligibility Criteria
Inclusion Criteria:
- age - 18+
- Contracture is 6 month old or more
- Place of contracture in a flex-ext joint only (e.g knee, elbow)
- Contracture leads to 15% decrease in joint range of movement vs anatomical range
- Physiotherapy can no longer improve those patients condition
Exclusion Criteria:
- Any systemic condition involving skin or soft tissue disease
- skin disease related to elastin, collagen or keratinocytes
- Known allergy to Clostridium Collagenase enzyme
- Psychiatric, Prisoners, Soldiers, Pregnant women
- Patients whom due to their home location will not be available to frequent surveillance
Sites / Locations
- Sheba Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Xiaflex ( Collagenase use)
Arm Description
all 10 patients will be selected from out burn's clinic pool and will be injected using collagenase
Outcomes
Primary Outcome Measures
Increase functionality of involved joint
range of motion of the joint involved will be measured using Goniometer
Pain assessment
will be measured using VAS pain scale
Increase functionality of involved joint
range of motion of the joint involved will be measured using Goniometer
Increase functionality of involved joint
range of motion of the joint involved will be measured using Goniometer
Pain assessment
will be measured using VAS pain scale
Pain assessment
will be measured using VAS pain scale
Secondary Outcome Measures
Full Information
NCT ID
NCT01237964
First Posted
November 3, 2010
Last Updated
November 9, 2010
Sponsor
Sheba Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01237964
Brief Title
Injectable Collagenase For Burns' Associated Contracture
Official Title
Phase 2 Of Injectable Collagenase (Xiaflex) For Burns' Associated Contracture
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Unknown status
Study Start Date
March 2011 (undefined)
Primary Completion Date
April 2011 (Anticipated)
Study Completion Date
August 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Sheba Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A pilot experiment to test the efficiency of the enzyme Collagenase in treating contractures which result's from burn's healing process.
So far, treatment of choice in patients with burn's created movement limiting contractures, concentrated around supportive care. Patients were referred to surgical intervention only if necessary. Treatment by injecting an external enzyme is avant-garde and hasn't been done under such conditions.
This study might introduce a new kind of treatment, which can be done in ambulatory environment .This type of treatment might significantly improve patients' function and quality of life, with no need for a surgical intervention.
Detailed Description
Scientific Background:
Contracture is defined as a scar tissue that replaces the original tissue and leads to shortening and tightening of the muscle results in a range of motion limitation and deformity. Contracture creation is common in burn's healing process. The process itself involves fibrosis of the effected area including intrusion towards the deep layers of the skin, and can be described as ineffective healing process. In many cases these scars have major functional and cosmetic implications that challenges the plastic surgery departments around the world.
Creation of bands, webs and contractures close to a joint area can cause a significant movement limitation and shortens the range of motion. Until recently, failure of treatment with bandaging, splints and physiotherapy activity usually led to surgical intervention involving many kinds of techniques ranging from simple incisions, Z-Plasties to skin grafts, and flaps. All these methods were meant to release the contracture itself and restore the functional capability.
A recent study showed that it's possible to use the collagenase enzyme in releasing dupuytren's contracture by a simple injection, a procedure that can be preformed under ambulatory conditions. This kind of contracture causes a fixed flexion of the fingers towards the palm of the hand. The study was a double blinded, placebo controlled study and involved 308 patients, all suffered from contracture with at least 20 degrees range of movement limitation. In the end, it was proved beyond any doubt that collagenase is effective in releasing and restoring range of motion of dupuytren's contracture. These positive results might indicate the possibility of using collagenase in other kinds of contractures.
In this study the investigators intend to perform a preliminary test of the effectiveness of collagenase in treating contracture that developed due to the burn's healing process. As comparison parameters the investigators will compare the range of motion before and after treatment and subjective feeling of pain (again, before and after treatment) according to VAS scale of pain. Also the investigators will try to monitor any kind of side effects that might appear.
In the clinical aspect, this study might introduce the medical community with a new kind of treatment protocols and even might decrease the need for surgical intervention in these patients.
Goal:
A pilot experiment to test the efficiency of the enzyme Collagenase in treating contractures which result's from burn's healing process.
Methods:
During the study the investigators will recruit about 10 patients which suffer from a known contracture that causes movement's restriction and can be attributed to burn's healing process. These patients will have to meet the exclusion and inclusion criteria of the study.
Patients will sign an informed consent in according to the Helsinki Committee, containing the list of complications and side effects expected. Patients will go through Collagenase enzyme injections according to the protocol that was conducted in the dupuytren's study. Before performing the injections, the range of motion's limitations will be measured using goniometer and a pain scale questionnaire (VAS) will be filled by the patient. Remeasuring will be done in several time periods, after the first injection, ranging from 24 hours, a week, 14 days and 28 days.
Expected results and research significance:
So far, treatment of choice in patients with burn's created movement limiting contractures, concentrated around supportive care. Patients were referred to surgical intervention only if necessary .Treatment by injecting an external enzyme is avant-garde and hasn't been done under such conditions.
Injections attempts of various enzymes such as hyaluronidase , Collagenase and also Gelatinase are documented in the literature as therapeutic trial for Keloid and hypertrophic scars in the aesthetic aspect, were found ineffective. However, literature review found no evidence of therapeutic attempts using Collagenase in burn's healing contracture for the functional aspect. These processes are known to be fibrotic and rich with collagen deposition.
This study might introduce a new kind of treatment, which can be done in ambulatory environment .This type of treatment might significantly improve patients' function and quality of life, with no need for a surgical intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burn's Associated Contracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Xiaflex ( Collagenase use)
Arm Type
Experimental
Arm Description
all 10 patients will be selected from out burn's clinic pool and will be injected using collagenase
Intervention Type
Drug
Intervention Name(s)
Xiaflex (FDA approved collagenase)
Other Intervention Name(s)
Xiaflex( Collagenase Clostridium Histolytiucm), https://www.xiaflex.com/
Intervention Description
0.58mg of collagenase will be diluted in saline and injected in 3 points surrounding the limiting contracture
Primary Outcome Measure Information:
Title
Increase functionality of involved joint
Description
range of motion of the joint involved will be measured using Goniometer
Time Frame
24 hours after injection
Title
Pain assessment
Description
will be measured using VAS pain scale
Time Frame
24 hours after injection
Title
Increase functionality of involved joint
Description
range of motion of the joint involved will be measured using Goniometer
Time Frame
14 days after injection
Title
Increase functionality of involved joint
Description
range of motion of the joint involved will be measured using Goniometer
Time Frame
28 days after injection
Title
Pain assessment
Description
will be measured using VAS pain scale
Time Frame
14 days after injection
Title
Pain assessment
Description
will be measured using VAS pain scale
Time Frame
28 days after injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age - 18+
Contracture is 6 month old or more
Place of contracture in a flex-ext joint only (e.g knee, elbow)
Contracture leads to 15% decrease in joint range of movement vs anatomical range
Physiotherapy can no longer improve those patients condition
Exclusion Criteria:
Any systemic condition involving skin or soft tissue disease
skin disease related to elastin, collagen or keratinocytes
Known allergy to Clostridium Collagenase enzyme
Psychiatric, Prisoners, Soldiers, Pregnant women
Patients whom due to their home location will not be available to frequent surveillance
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joseph Haik, MD
Phone
972-3-5302416
First Name & Middle Initial & Last Name or Official Title & Degree
Omer Trivizki, B.Sc
Phone
972-3-5302416
Email
omertr@gmail.com
Facility Information:
Facility Name
Sheba Hospital
City
Ramat Gan
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Haik, MD
Phone
972-3-5302416
First Name & Middle Initial & Last Name & Degree
Joseph Haik, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
19726771
Citation
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.
Results Reference
result
Links:
URL
https://www.xiaflex.com/
Description
xiaflex product which will be used during the study
Learn more about this trial
Injectable Collagenase For Burns' Associated Contracture
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