Topical Pirfenidone Effective in Treatment of Diabetic Foot Ulcers

June 10, 2015

By Nancy A. Melville

BOSTON -- June 10, 2015 -- The addition of topical pirfenidone to conventional treatment significantly improves the healing of chronic foot ulcers in patients with diabetes, according to late-breaking results from a crossover study presented on June 6 at the 75th Scientific Sessions of the American Diabetes Association (ADA).



Although best known as an anti-fibrotic drug used in the treatment of idiopathic pulmonary fibrosis, a topical formulation of pirfenidone is being examined for wound healing.


Marcela Janka-Zires, MD, Unidad de Terapia Intensiva, Fundación Clínica Médica, México, and colleagues randomised patients with diabetic foot ulcers with Wagner 1 or 2 and at least 2 weeks duration to treatment with 1 of 2 regimens. In the first treatment, patients received topical pirfenidone plus conventional treatment for 8 weeks. After the treatment period, patients continued with conventional therapy for another 8 weeks.


In the second group, patients were first treated with conventional therapy and subsequently received pirfenidone treatment for the remaining 8 weeks.


Results showed as many as 50% of patients in the pirfenidone group healed before 8 weeks compared with just 14.3% of patients in the conventional therapy group (P = .032).


In the 8- to 16-week period, 30.8% of patients receiving pirfenidone healed, compared with none in the conventional therapy group (P = .067).


Ulcers had a reduction in size of 98% by week 8 in the pirfenidone group, versus a reduction of 57.5% in the conventional-therapy group, and, by week 16, the reduction in ulcer size was 93% in the pirfenidone group compared with 20% with conventional therapy (P = .032).


Patients in this study had a mean age of 57 years, and diabetes evolution of 16.5 years. There were no differences in ulcer size at baseline.


“In diabetic chronic foot ulcers, the addition of topical pirfenidone to conventional treatment is associated with a superior percentage of ulcer healing, and a significant reduction in the percentage size,” Dr. Janka-Ziresc concluded.


[Presentation title: Topical Administration of Pirfenidone Increases Healing of Chronic Diabetic Foot Ulcers: A Randomized Crossover Study. Abstract LB-45]




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