Effect of Topic Pirfenidone in Diabetic Ulcers

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Diabetic Foot Ulcers

Intervention / Treatment
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* Drug: Pirfenidone
* Procedure: Debridement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men or women Type 1 or 2 diabetes Age ≥ 18 years Wagner 1 or 2 diabetic foot ulcer Diabetic ulcer for more than 8 weeks duration Willing to participate in the study with signed informed consent Exclusion Criteria: Ankle/brachial index < 0.4 (critic ischemia) Use topical or systemic antibiotics Inability to attend to the weekly evaluations Inability to do daily ulcer cleansing Autoimmune diseases Active pharmacologic topical or systemic ulcer treatment Treatment with immunosuppressors such as steroids, radiotherapy, chemotherapy Pregnancy or lactation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional treatment<br>Weekly ulcer debridement and daily cleansing | Procedure: Debridement<br>* Weekly ulcer debridement<br>|
| Experimental: Pirfenidone<br>Weekly ulcer debridement, daily cleansing, plus twice a day topical pirfenidone application | Drug: Pirfenidone<br>* Twice a day topical application<br>* Other names: Kitoscell Q;Procedure: Debridement<br>* Weekly ulcer debridement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ulcer size |  | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic ulcer, diabetic foot