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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02222376

Acronym

PirDFI

Enrollment

Registered

2014-08-21

Start date

2013-10-31

Completion date

2015-04-30

Last updated

2016-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Foot Ulcers

Keywords

Diabetic ulcer, diabetic foot

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.

Interventions

DRUGPirfenidone

Twice a day topical application

PROCEDUREDebridement

Weekly ulcer debridement

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Ulcer size	16 weeks

Other

Measure	Time frame
Healed ulcers	16 weeks
Adverse effects	16 weeks
Healing time	16 weeks

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026