Matrix Metalloproteinase-1/Tissue Inhibitor of Metalloproteinase-1 (MMP-1/TIMP-1) Ratio and Diabetic Foot Ulcers (DIAB-MMP2)
|Diabetic Foot Ulcer||Other: Picture + MMPs and TIMP1 at week 0 and week 4||Early Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||Assessment of the MMP-1/TIMP-1 Ratio as a Predictor of Wound Healing in Diabetic Foot Ulcers|
- 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 ]
- 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 ]
- 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 ]
- 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 ]
|Study Start Date:||May 2009|
|Study Completion Date:||November 2013|
|Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
Experimental: 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.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00935051
|Grenoble, Isere, France, 38043|
|Service de Diabétologie du Pr Halimi, CHU Grenoble|
|Grenoble Cedex 9, France, 38043|
|Study Director:||Pierre-Yves Benhamou, PhD||University Hospital, Grenoble|