Effect of Topic Pirfenidone in Diabetic Ulcers (PirDFI)

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Status and phase: Completed; Phase 3

Conditions: Diabetic Foot Ulcers

Treatments: Procedure: Debridement; Drug: Pirfenidone

Study type: Interventional

Funder types: Other

Identifiers

NCT02222376

DIA-1031-13/14-1

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Conventional treatment

Active Comparator group

Description:

Weekly ulcer debridement and daily cleansing

Treatment:

Procedure: Debridement

Pirfenidone

Experimental group

Description:

Weekly ulcer debridement, daily cleansing, plus twice a day topical pirfenidone application

Treatment:

Drug: Pirfenidone

Procedure: Debridement