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Injectable Collagenase For Burns' Associated Contracture

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by:
Sheba Medical Center

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.


Condition or disease Intervention/treatment Phase
Burn's Associated Contracture Drug: Xiaflex (FDA approved collagenase) Phase 2

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

Arm Intervention/treatment
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
Other Names:
  • Xiaflex( Collagenase Clostridium Histolytiucm)
  • https://www.xiaflex.com/




Primary Outcome Measures :
  1. Increase functionality of involved joint [ Time Frame: 24 hours after injection ]
    range of motion of the joint involved will be measured using Goniometer

  2. Pain assessment [ Time Frame: 24 hours after injection ]
    will be measured using VAS pain scale

  3. Increase functionality of involved joint [ Time Frame: 14 days after injection ]
    range of motion of the joint involved will be measured using Goniometer

  4. Increase functionality of involved joint [ Time Frame: 28 days after injection ]
    range of motion of the joint involved will be measured using Goniometer

  5. Pain assessment [ Time Frame: 14 days after injection ]
    will be measured using VAS pain scale

  6. Pain assessment [ Time Frame: 28 days after injection ]
    will be measured using VAS pain scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. age - 18+
  2. Contracture is 6 month old or more
  3. Place of contracture in a flex-ext joint only (e.g knee, elbow)
  4. Contracture leads to 15% decrease in joint range of movement vs anatomical range
  5. Physiotherapy can no longer improve those patients condition

Exclusion Criteria:

  1. Any systemic condition involving skin or soft tissue disease
  2. skin disease related to elastin, collagen or keratinocytes
  3. Known allergy to Clostridium Collagenase enzyme
  4. Psychiatric, Prisoners, Soldiers, Pregnant women
  5. Patients whom due to their home location will not be available to frequent surveillance

Information from the National Library of Medicine

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


Contacts
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Contact: Joseph Haik, MD 972-3-5302416
Contact: Omer Trivizki, B.Sc 972-3-5302416 omertr@gmail.com

Locations
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Israel
Sheba Hospital
Ramat Gan, Israel
Contact: Joseph Haik, MD    972-3-5302416      
Principal Investigator: Joseph Haik, MD         
Sponsors and Collaborators
Sheba Medical Center

Additional Information:
Publications of Results:
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Responsible Party: Joseph Haik, MD, Director of burn's unit, Plastic Surgery Department, Sheba Hospital
ClinicalTrials.gov Identifier: NCT01237964    
Other Study ID Numbers: SHEBA-10-7631-JH-CTIL
First Posted: November 10, 2010    Key Record Dates
Last Update Posted: November 10, 2010
Last Verified: November 2010
Additional relevant MeSH terms:
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Contracture
Burns
Wounds and Injuries
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases