Diabetic Foot Ulcer Clinical Trial
Official title:
Assessment of the MMP-1/TIMP-1 Ratio as a Predictor of Wound Healing in Diabetic Foot Ulcers
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.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
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