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Journal of Diabetes Research
Volume 2017 (2017), Article ID 3159798, 12 pages
Clinical Study

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

1Institute for Molecular Biology and Gene Therapy, CUCS, University of Guadalajara, Guadalajara, JAL, Mexico
2Regional Hospital Dr. Valentín Gómez Farías ISSSTE, Guadalajara, JAL, Mexico
3Tecnologico de Monterrey, Campus Guadalajara, Jalisco, Mexico
4Hospital Civil de Guadalajara, Guadalajara, JAL, Mexico
5Institute of Chronic-Degenerative Diseases, CUCS, University of Guadalajara, Guadalajara, JAL, Mexico

Correspondence should be addressed to Juan Armendariz-Borunda

Received 25 July 2017; Revised 16 November 2017; Accepted 3 December 2017; Published 31 December 2017

Academic Editor: Mark Yorek

Copyright © 2017 Luz E. Gasca-Lozano et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.


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-1α, COL-4, KGF, VEGF, ACTA2 (α-SMA), elastin, fibronectin, TGF-β1, TGF-β3, HIF-1α, and HIF-1β. 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.