NCT02222376

Effect of Topic Pirfenidone in Diabetic Ulcers

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Diabetic Foot Ulcers

Interventions

Type	Name	Description
DRUG	Pirfenidone	Twice a day topical application
PROCEDURE	Debridement	Weekly ulcer debridement

Timeline

• Start date: 2013-10-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2014-08-21
• Last updated: 2016-02-15

Locations

1 site across 1 country: Mexico