Status:
COMPLETED
Matrix Metalloproteinase-1/Tissue Inhibitor of Metalloproteinase-1 (MMP-1/TIMP-1) Ratio and Diabetic Foot Ulcers
Lead Sponsor:
University Hospital, Grenoble
Conditions:
Diabetic Foot Ulcer
Eligibility:
All Genders
18-40 years
Phase:
EARLY_PHASE1
Brief Summary
The primary objective of this study is to assess the sensitivity and specificity of a MMP-1/TIMP-1 ratio equal to 0.24 at study entry to predict wound healing at 12 weeks' follow up visit.
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT00935051
Start Date
May 1 2009
End Date
November 1 2013
Last Update
December 18 2013
Active Locations (2)
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1
Diabetology department
Grenoble, Isere, France, 38043
2
Service de Diabétologie du Pr Halimi, CHU Grenoble
Grenoble, France, 38043