Injectable Collagenase For Burns' Associated Contracture
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|ClinicalTrials.gov Identifier: NCT01237964|
Recruitment Status : Unknown
Verified November 2010 by Sheba Medical Center.
Recruitment status was: Not yet recruiting
First Posted : November 10, 2010
Last Update Posted : November 10, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Burn's Associated Contracture||Drug: Xiaflex (FDA approved collagenase)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2 Of Injectable Collagenase (Xiaflex) For Burns' Associated Contracture|
|Study Start Date :||March 2011|
|Estimated Primary Completion Date :||April 2011|
|Estimated Study Completion Date :||August 2011|
Experimental: Xiaflex ( Collagenase use)
all 10 patients will be selected from out burn's clinic pool and will be injected using collagenase
Drug: Xiaflex (FDA approved collagenase)
0.58mg of collagenase will be diluted in saline and injected in 3 points surrounding the limiting contracture
- Increase functionality of involved joint [ Time Frame: 24 hours after injection ]range of motion of the joint involved will be measured using Goniometer
- Pain assessment [ Time Frame: 24 hours after injection ]will be measured using VAS pain scale
- Increase functionality of involved joint [ Time Frame: 14 days after injection ]range of motion of the joint involved will be measured using Goniometer
- Increase functionality of involved joint [ Time Frame: 28 days after injection ]range of motion of the joint involved will be measured using Goniometer
- Pain assessment [ Time Frame: 14 days after injection ]will be measured using VAS pain scale
- Pain assessment [ Time Frame: 28 days after injection ]will be measured using VAS pain scale
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01237964
|Contact: Joseph Haik, MD||972-3-5302416|
|Contact: Omer Trivizki, B.Scfirstname.lastname@example.org|
|Ramat Gan, Israel|
|Contact: Joseph Haik, MD 972-3-5302416|
|Principal Investigator: Joseph Haik, MD|