Matrix Metalloproteinase-1/Tissue Inhibitor of Metalloproteinase-1 (MMP-1/TIMP-1) Ratio and Diabetic Foot Ulcers

NCT ID: NCT00935051

Last Updated: 2013-12-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2013-11-30

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.

Conditions

Diabetic Foot Ulcer

Keywords

type 1 diabetes; type 2 diabetes; Diabetic foot ulcer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Picture + MMPs and TIMP1 at week 0 and week 4

Intervention Type: OTHER

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.

Interventions

Picture + MMPs and TIMP1 at week 0 and week 4

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre-Yves Benhamou, PhD

Role: STUDY_DIRECTOR

University Hospital, Grenoble

Locations

Diabetology department

Grenoble, Isere, France

Service de Diabétologie du Pr Halimi, CHU Grenoble

Grenoble, , France

Countries

France

Other Identifiers

2008-A00155-50

Identifier Type: -

Identifier Source: org_study_id