Burn's Associated ContracturePhase 2NCT01237964
Injectable Collagenase For Burns' Associated Contracture
A Phase 2 study testing Xiaflex (FDA approved collagenase) in people with Burn's Associated Contracture, run by Sheba Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Burn's Associated Contracture
- What is being tested?
- Xiaflex (FDA approved collagenase)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2011to Aug 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Joseph Haik, MD contact
Israel1 site
Sheba Hospital
Ramat Gan
Joseph Haik, MD, 972-3-5302416
Joseph Haik, MD
About this study
Official title: Phase 2 Of Injectable Collagenase (Xiaflex) For Burns' Associated Contracture
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.
Read the 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.
- Conditions
- Burn's Associated Contracture
- Being tested
- Xiaflex (FDA approved collagenase)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xiaflex (FDA approved collagenase)Drug
Also called Xiaflex( Collagenase Clostridium Histolytiucm), https://www.xiaflex.com/
0.58mg of collagenase will be diluted in saline and injected in 3 points surrounding the limiting contracture
| Study group | Role | What they receive |
|---|---|---|
| Xiaflex ( Collagenase use) | Experimental | all 10 patients will be selected from out burn's clinic pool and will be injected using collagenase Receives: Drug: Xiaflex (FDA approved collagenase) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase functionality of involved joint
range of motion of the joint involved will be measured using Goniometer
Measured: 24 hours after injection
Pain assessment
will be measured using VAS pain scale
Measured: 24 hours after injection
Increase functionality of involved joint
range of motion of the joint involved will be measured using Goniometer
Measured: 14 days after injection
Increase functionality of involved joint
range of motion of the joint involved will be measured using Goniometer
Measured: 28 days after injection
Pain assessment
will be measured using VAS pain scale
Measured: 14 days after injection
Pain assessment
will be measured using VAS pain scale
Measured: 28 days after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2010 (estimated)
- Study startMar 2011
- Primary completionApr 2011 (estimated)
- Study completionAug 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Burn's Associated ContractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01237964
- Sponsor's protocol ID
- SHEBA-10-7631-JH-CTIL
- Status last verified
- Nov 2010
- First submitted
- 3 Nov 2010
- Last updated
- 10 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 19726771
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Of Injectable Collagenase (Xiaflex) For Burns' Associated Contracture
- ClinicalTrials.gov ID
- NCT01237964
- Acronym / sponsor ID
- SHEBA-10-7631-JH-CTIL
- Conditions
- Burn's Associated Contracture
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Mar 2011
- Primary completion
- Apr 2011 (estimated)
- Study completion
- Aug 2011 (estimated)
- First posted
- 10 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Xiaflex ( Collagenase use) | Experimental | Drug: Xiaflex (FDA approved collagenase)all 10 patients will be selected from out burn's clinic pool and will be injected using collagenase |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xiaflex (FDA approved collagenase)Also: Xiaflex( Collagenase Clostridium Histolytiucm), https://www.xiaflex.com/0.58mg of collagenase will be diluted in saline and injected in 3 points surrounding the limiting contracture | Drug | Xiaflex ( Collagenase use) |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2010.
- Results publication: PubMed 19726771Hurst 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.
- xiaflex product which will be used during the studyLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Haik, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Xiaflex (FDA approved collagenase) in people with Burn's Associated Contracture, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joseph Haik, MD (972-3-5302416), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase functionality of involved joint (time frame: 24 hours after injection). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01237964, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2010.