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Pirfenidone Accelerates Wound Healing in Chronic Diabetic Foot Ulcers: A Randomized, Double-Blind Controlled Trial

2017; Hindawi Publishing Corporation; Volume: 2017; Linguagem: Inglês

10.1155/2017/3159798

2314-6753

Luz Elena Gasca-Lozano, Silvia Lucano‐Landeros, Héctor Ruiz-Mercado, Adriana María Salazar-Montes, Ana Sandoval-Rodríguez, Jesús García‐Bañuelos, Arturo Santos, Judith Rebeca Davila-Rodriguez, José Navarro‐Partida, Hiram Bojórquez-Sepúlveda, Juan Castañeda-Gomez, José Alfredo Domínguez‐Rosales, Myriam A. Ruiz-Arcos, María Guadalupe Sánchez‐Parada, Juan Armendáriz‐Borunda,

Pomegranate: compositions and health benefits

Background . Diabetic foot ulcers are one disabling complication of diabetes mellitus. Pirfenidone (PFD) is a potent modulator of extracellular matrix. Modified diallyl disulfide oxide (M-DDO) is an antimicrobial and antiseptic agent. Aim . To evaluate efficacy of topical PFD + M-DDO in a randomized, double-blind trial versus ketanserin in the treatment of noninfected chronic DFU. Methods . Patients received PFD + M-DDO or ketanserin for 6 months. Relative ulcer volume (RUV) was measured every month; biopsies were taken at baseline and months 1 and 2 for histopathology and gene expression analysis for COL-1 α , COL-4, KGF, VEGF, ACTA2 ( α -SMA), elastin, fibronectin, TGF- β 1, TGF- β 3, HIF-1 α , and HIF-1 β . Results . Reduction of median RUV in the PFD + M-DDO group was 62%, 89.8%, and 99.7% at months 1–3 and 100% from months 4 to 6. Ketanserin reduced RUV in 38.4%, 56%, 60.8%, 94%, 94.8%, and 100% from the first to the sixth month, respectively. Healing score improved 4.5 points with PFD + M-DDO and 1.5 points with ketanserin compared to basal value. Histology analysis revealed few inflammatory cells and organized/ordered collagen fiber bundles in PFD + M-DDO. Expression of most genes was increased with PFD + M-DDO; 43.8% of ulcers were resolved using PFD + M-DDO and 23.5% with ketanserin. Conclusion . PFD + M-DDO was more effective than ketanserin in RUV reduction.