- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00935051
Matrix Metalloproteinase-1/Tissue Inhibitor of Metalloproteinase-1 (MMP-1/TIMP-1) Ratio and Diabetic Foot Ulcers (DIAB-MMP2)
Assessment of the MMP-1/TIMP-1 Ratio as a Predictor of Wound Healing in Diabetic Foot Ulcers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This monocentric, prospective, non-randomized study assesses the amount of the main metalloproteinases (MMP1, MMP9, MMP13) and their inhibitor TIMP-1 in wound fluid from diabetic foot ulcers.
It aims at demonstrating whether a MMP-1/TIMP-1 ratio equal to 0.24 at study entry can predict wound healing 12 weeks later. All patients will receive the same treatment according to our local protocol. The difference with standard care will be a sample of wound fluid at week 0 and week 4 and a numeric photograph for wound area measurement at week 0, week 4 and week 12.
The main outcome measurement is the percent change of wound area between week 0 and week 12 Secondary objectives include the evaluation of a MMP-1/TIMP-1 ratio equal to 0.4 and the search for confounding factors. A correlation between MMP-9, MMP-13 and wound healing will also be investigated.
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
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Grenoble Cedex 9, France, 38043
- Service de Diabétologie du Pr Halimi, CHU Grenoble
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Isere
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Grenoble, Isere, France, 38043
- Diabetology department
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with type 1 or type 2 diabetes
- Age over 40
- Chronic diabetic foot ulcer (duration over 30 days)
- Grade 1 to 3, stage A and C according to the University of Texas Wound Classification, except stage B and D
- Wound area over 0.5 cm²
- Social Security membership or benefit from Social Security
- Informed consent, with a signed and approved form
- Possibility to have clinical follow-up and compliance during 3 months
Exclusion Criteria:
- Urgent need for locoregional surgery
- Clinical criteria for infection, defined by the presence of pus or/and at least 2 local signs among the following: heat, erythema, lymphangitis, lymphadenopathy, oedema, pain
- Other pathology that could interfere with the healing process (vasculitis, connectivitis, dysimmunity, immunosuppressive treatment or corticoids, ongoing radiotherapy or chemotherapy )
- Any severe pathology that would constitute a contra-indication to the patient's inclusion
- Ongoing therapeutic research protocol
- Underage patient, major patient under guardianship or protected by the Law
- Pregnant, parturient or breastfeeding woman
- Person with no freedom (prisoner), person in an emergency situation, person hospitalized without consent and not protected by the Law
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Arm 1
There is only one group of patients.
Thus there is only one arm.
Sample of wound fluid will be collected using a non traumatic procedure at week 0 and week 4. A numeric photograph of the wound will be taken at week 0, week 4 and week 12.
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Sample of wound fluid will be collected using a non traumatic procedure at week 0 and week 4.
This will allow to assess the level of MMP9, MMP13, MMP1 and TIMP1.
A numeric photograph of the wound will be taken at week 0, week 4 and week 12 in order to assess wound area.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
MMP-1/TIMP-1 ratio at Week 0 assessed by ELISA and percent change in wound area of diabetic foot ulcer between week 0, week 4 and week 12
Time Frame: Week 0, week 4 and week 12
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Week 0, week 4 and week 12
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluation of a MMP-1/TIMP-1 ratio = 0.4 at Week 0 as a predictor of wound healing at week 12
Time Frame: Week 0, week 4 and week 12
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Week 0, week 4 and week 12
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Recognized clinical prognostic factors such as wound duration, wound area, wound depth and other possible confounding factors affecting the validity of the MMP-1/TIMP-1 ratio
Time Frame: Week 0 to Week 12
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Week 0 to Week 12
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Correlation between MMP9, MMP13, MMP9/TIMP1 and MMP13/ TIMP1 ratios and wound healing expressed by the percent change in wound area between week 0, week 4 and week 12.
Time Frame: Week 0 and week 4
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Week 0 and week 4
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Pierre-Yves Benhamou, PhD, University Hospital, Grenoble
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2008-A00155-50
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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