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

ABSTRACT: 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?, COL-4, KGF, VEGF, ACTA2 (?-SMA), elastin, fibronectin, TGF-?1, TGF-?3, HIF-1?, and HIF-1?. 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.

SUBMITTER: Gasca-Lozano LE 

PROVIDER: S-EPMC5840678 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature