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

Diabetic Foot Ulcer Clinical Trial

— DIAB-MMP2  

Official title:

Assessment of the MMP-1/TIMP-1 Ratio as a Predictor of Wound Healing in Diabetic Foot Ulcers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00935051
• Other study ID #: 2008-A00155-50
• Status: Completed
• Phase: Phase 0
• First received: July 2, 2009
• Last updated: December 17, 2013
• Start date: May 2009
• Est. completion date: November 2013

Study information

• Verified date: December 2013
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: November 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

Intervention

Other:
• 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.

Locations

Country	Name	City	State
France	Diabetology department	Grenoble	Isere
France	Service de Diabétologie du Pr Halimi, CHU Grenoble	Grenoble Cedex 9

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Week 0, week 4 and week 12	No
Secondary	Evaluation of a MMP-1/TIMP-1 ratio = 0.4 at Week 0 as a predictor of wound healing at week 12		Week 0, week 4 and week 12	No
Secondary	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		Week 0 to Week 12	No
Secondary	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.		Week 0 and week 4	No