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Matrix Metalloproteinase-1/Tissue Inhibitor of Metalloproteinase-1 (MMP-1/TIMP-1) Ratio and Diabetic Foot Ulcers (DIAB-MMP2)

Primary Purpose

Diabetic Foot Ulcer

Status
Completed
Phase
Early Phase 1
Locations
France
Study Type
Interventional
Intervention
Picture + MMPs and TIMP1 at week 0 and week 4
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Diabetic Foot Ulcer focused on measuring type 1 diabetes, type 2 diabetes, Diabetic foot ulcer

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Diabetology department
  • Service de Diabétologie du Pr Halimi, CHU Grenoble

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

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.

Outcomes

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

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
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
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.

Full Information

First Posted
July 2, 2009
Last Updated
December 17, 2013
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT00935051
Brief Title
Matrix Metalloproteinase-1/Tissue Inhibitor of Metalloproteinase-1 (MMP-1/TIMP-1) Ratio and Diabetic Foot Ulcers
Acronym
DIAB-MMP2
Official Title
Assessment of the MMP-1/TIMP-1 Ratio as a Predictor of Wound Healing in Diabetic Foot Ulcers
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer
Keywords
type 1 diabetes, type 2 diabetes, Diabetic foot ulcer

7. Study Design

Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Picture + MMPs and TIMP1 at week 0 and week 4
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre-Yves Benhamou, PhD
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Study Director
Facility Information:
Facility Name
Diabetology department
City
Grenoble
State/Province
Isere
ZIP/Postal Code
38043
Country
France
Facility Name
Service de Diabétologie du Pr Halimi, CHU Grenoble
City
Grenoble Cedex 9
ZIP/Postal Code
38043
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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