Effect of Topic Pirfenidone in Diabetic Ulcers

Phase 3

Completed

• Conditions: Diabetic Foot Ulcers
• Interventions: Procedure: Debridement; Drug: Pirfenidone

• Registration Number: NCT02222376
• Lead Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2014-08-19
• Study First Submitted QC: 2014-08-19
• Study First Posted: 2014-08-21
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-12
• Last Update Posted: 2016-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1. Men or women
2. Type 1 or 2 diabetes
3. Age ≥ 18 years
4. Wagner 1 or 2 diabetic foot ulcer
5. Diabetic ulcer for more than 8 weeks duration
6. Willing to participate in the study with signed informed consent

Exclusion Criteria

1. Ankle/brachial index < 0.4 (critic ischemia)
2. Use topical or systemic antibiotics
3. Inability to attend to the weekly evaluations
4. Inability to do daily ulcer cleansing
5. Autoimmune diseases
6. Active pharmacologic topical or systemic ulcer treatment
7. Treatment with immunosuppressors such as steroids, radiotherapy, chemotherapy
8. Pregnancy or lactation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Conventional treatment	Debridement	Weekly ulcer debridement and daily cleansing
Pirfenidone	Debridement	Weekly ulcer debridement, daily cleansing, plus twice a day topical pirfenidone application
Pirfenidone	Pirfenidone	Weekly ulcer debridement, daily cleansing, plus twice a day topical pirfenidone application

Primary Outcome Measures

Name	Time	Method
Ulcer size	16 weeks

Trial Locations

Locations (1)

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran; 🇲🇽 Mexico City, Distrito Federal, Mexico