Diabetic Foot Ulcers Clinical Trial
Official title:
Effect of Treatment of Diabetic Foot Ulcers With Topic 8% 1-phenyl-5-methyl-2-[1h]-Pyridone (Pirfenidone) Combined With Modified Disulfur Diallyl Oxide (Odd-m) in Gel.
Pirfenidone is a synthetic molecule, which acts as a potent modulator of the effect of
various cytokines (TNF-α, transforming growth factor-β, platelet derived growth factor and
vascular endothelial growth factor, among others) that possesses anti-inflammatory and
anti-fibrinolytic properties.
The aim of this study is to compare the effect of topic treatment with pirfenidone compared
to conventional treatment in chronic diabetic foot ulcers.
The hypothesis is that treatment with topic pirfenidone in chronic diabetic foot ulcers
(Wagner 1 to 2) reduces the ulcer size and shortens the healing time compared to
conventional treatment. This is a randomized, controlled and crossover study. Patients will
be randomly assigned to conventional treatment or topic pirfenidone for eight weeks. At the
end of this period they will change groups. Each week ulcers will be for size, depth, length
and evidence of infection. The ulcers will have proper debridement in the conventional
treatment group and debridement plus topical pirfenidone application in the pirfenidone
group. Subjects will be instructed to do daily ulcer cleansing and for those in the topical
pirfenidone group, in addition to cleansing they will be instructed to apply the gel twice a
day.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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