An Early Phase 1 interventional study of Picture + MMPs and TIMP1 at week 0 and week 4 in Diabetic Foot Ulcer, sponsored by University Hospital, Grenoble. Completed at 2 sites in France. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2013-12-18.
Sponsored by University Hospital, Grenoble · Early Phase 1, Interventional, and Basic science
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.
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.
1,077 studies on the registry are indexed under Diabetic Foot; 224 are open to participants now.
This study's enrollment of 59 is close to the median of 60 across 845 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →University Hospital, Grenoble is the lead sponsor of 835 studies on the registry; 207 are open to participants now.
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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.
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
This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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