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

Sponsor:	University Hospital, Grenoble
Information provided by:	University Hospital, Grenoble
ClinicalTrials.gov Identifier:	NCT00935051

Purpose

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.

Condition	Intervention	Phase
Diabetic Foot Ulcer	Other: Picture + MMPs and TIMP1 at week 0 and week 4	Phase 0

Study Type:	Interventional
Study Design:	Basic Science, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	Assessment of the MMP-1/TIMP-1 Ratio as a Predictor of Wound Healing in Diabetic Foot Ulcers

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetic Foot Foot Health

U.S. FDA Resources

Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	62
Study Start Date:	May 2009
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental 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.	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.

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

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00935051

Contacts

Contact: Marie Muller, PhD

Mmuller@chu-grenoble.fr

Locations

France
Service de Diabétologie du Pr Halimi, CHU Grenoble	Not yet recruiting
Grenoble Cedex 9, France, 38043
Contact: Marie Muller, PhD Mmuller@chu-grenoble.fr
Principal Investigator: Marie Muller, PhD
Sub-Investigator: Sylvie Pradines, PhD
France, Isere
Diabetology department	Recruiting
Grenoble, Isere, France, 38043
Contact: Muller Marie, MD
Principal Investigator: Muller Marie, MD

Sponsors and Collaborators

University Hospital, Grenoble

Investigators

Study Director:

Pierre-Yves Benhamou, PhD

University Hospital, Grenoble

More Information

No publications provided

Responsible Party:	University Hospital Grenoble ( Pr Pierre-Yves Benhamou )
Study ID Numbers:	2008-A00155-50
Study First Received:	July 2, 2009
Last Updated:	July 7, 2009
ClinicalTrials.gov Identifier:	NCT00935051 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Grenoble:

type 1 diabetes
type 2 diabetes
Diabetic foot ulcer

Additional relevant MeSH terms:

Foot Ulcer
Diabetic Neuropathies
Skin Diseases
Ulcer
Vascular Diseases
Diabetes Mellitus
Endocrine System Diseases
Foot Diseases

Diabetic Angiopathies
Pathologic Processes
Cardiovascular Diseases
Skin Ulcer
Diabetes Complications
Diabetic Foot
Leg Ulcer

ClinicalTrials.gov processed this record on November 20, 2009