title: Topical Administration of Pirfenidone Increases Healing of Chronic Diabetic Foot Ulcers: A Randomized Crossover Study.
abstract: Only 30 percent of chronic diabetic foot ulcers heal after 20 weeks of standard treatment. Pirfenidone is a drug with biological, anti-inflammatory, and antifibrotic effects. The aim of this study was to evaluate the effect of topical pirfenidone added to conventional treatment in noninfected chronic diabetic foot ulcers. This was a randomized crossover study. Group 1 received topical pirfenidone plus conventional treatment for 8 weeks; after this period, they were switched to receive conventional treatment only for 8 more weeks. In group 2, the order of the treatments was the opposite. The end points were complete ulcer healing and size reduction. Final data were obtained from 35 ulcers in 24 patients. Fifty-two percent of ulcers treated with pirfenidone healed before 8 weeks versus 14.3% treated with conventional treatment only (P = 0.025). Between 8 and 16 weeks, 30.8% ulcers that received pirfenidone healed versus 0% with conventional treatment (P = 0.081). By week 8, the reduction in ulcer size was 100% [73-100] with pirfenidone versus 57.5% with conventional treatment [28.9-74] (P = 0.011). By week 16, the reduction was 93% [42.7-100] with pirfenidone and 21.8% [8-77.5] with conventional treatment (P = 0.050). The addition of topical pirfenidone to conventional treatment significantly improves the healing of chronic diabetic noninfected foot ulcers.
authors.affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Endocrinology and Metabolism Department, Vasco de Quiroga 15, Colonia Belisario Domínguez Sección XVI, Tlalpan, 14080 Mexico City, CDMX, Mexico.
authors.forename: Marcela
authors.initials: M
authors.lastname: Janka-Zires
authors.affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Endocrinology and Metabolism Department, Vasco de Quiroga 15, Colonia Belisario Domínguez Sección XVI, Tlalpan, 14080 Mexico City, CDMX, Mexico.
authors.forename: Paloma
authors.identifier: 0000-0002-9701-5879
authors.initials: P
authors.lastname: Almeda-Valdes
authors.affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Endocrinology and Metabolism Department, Vasco de Quiroga 15, Colonia Belisario Domínguez Sección XVI, Tlalpan, 14080 Mexico City, CDMX, Mexico.
authors.forename: Ana Cecilia
authors.initials: AC
authors.lastname: Uribe-Wiechers
authors.affiliation: Grupo Ángeles, Camino a Santa Teresa 1055, Colonia Héroes de Padierna, Magdalena Contreras, 10700 Mexico City, CDMX, Mexico.
authors.forename: Sonia Citlali
authors.initials: SC
authors.lastname: Juárez-Comboni
authors.affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Endocrinology and Metabolism Department, Vasco de Quiroga 15, Colonia Belisario Domínguez Sección XVI, Tlalpan, 14080 Mexico City, CDMX, Mexico.
authors.forename: Joel
authors.initials: J
authors.lastname: López-Gutiérrez
authors.affiliation: Cell Pharma, Calzada de Las Bombas 128, 04980 Mexico City, CDMX, Mexico.
authors.forename: Jarod Jazek
authors.initials: JJ
authors.lastname: Escobar-Jiménez
authors.affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Endocrinology and Metabolism Department, Vasco de Quiroga 15, Colonia Belisario Domínguez Sección XVI, Tlalpan, 14080 Mexico City, CDMX, Mexico.
authors.forename: Francisco J
authors.initials: FJ
authors.lastname: Gómez-Pérez
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D002908:Chronic Disease; D018592:Cross-Over Studies; D003924:Diabetes Mellitus, Type 2; D017719:Diabetic Foot / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011728:Pyridones / Q000627:therapeutic use*; D016896:Treatment Outcome; D014945:Wound Healing
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D011728:Pyridones; C093844:pirfenidone