Clinical trial NCT00935051: Matrix Metalloproteinase-1/Tissue Inhibitor of Metalloproteinase-1 (MMP-1/TIMP-1) Ratio and Diabetic Foot Ulcers
Official title: Assessment of the MMP-1/TIMP-1 Ratio as a Predictor of Wound Healing in Diabetic Foot Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Diabetic Foot Ulcer
Keywords: type 1 diabetes
type 2 diabetes
Diabetic foot ulcer
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2009-07-08
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Week 0, week 4 and week 12
Secondary outcomes:
measure: Evaluation of a MMP-1/TIMP-1 ratio = 0.4 at Week 0 as a predictor of wound healing at week 12
timeFrame: Week 0, week 4 and week 12
measure: 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
timeFrame: Week 0 to Week 12
measure: 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.
timeFrame: Week 0 and week 4
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Diabetology department
state: Isere
city: Grenoble Cedex 9
country: France
facility: Service de Diabétologie du Pr Halimi, CHU Grenoble
Study officials:
affiliation: University Hospital, Grenoble
name: Pierre-Yves Benhamou, PhD
role: STUDY_DIRECTOR
References: