Pirfenidone Accelerates Wound Healing in Chronic Diabetic Foot Ulcers: A
Randomized, Double-Blind Controlled Trial
#MMPMID29675430
Gasca-Lozano LE
; Lucano-Landeros S
; Ruiz-Mercado H
; Salazar-Montes A
; Sandoval-Rodríguez A
; Garcia-Bañuelos J
; Santos-Garcia A
; Davila-Rodriguez JR
; Navarro-Partida J
; Bojórquez-Sepúlveda H
; Castañeda-Gomez J
; Domínguez-Rosales J
; Ruiz-Arcos MA
; Sánchez-Parada MG
; Armendariz-Borunda J
J Diabetes Res
2017[]; 2017
(?): 3159798
PMID29675430
show ga
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.
|Adult
[MESH]
|Aged
[MESH]
|Anti-Infective Agents/pharmacology/therapeutic use
[MESH]
|Anti-Inflammatory Agents, Non-Steroidal/pharmacology/*therapeutic use
[MESH]
|Diabetic Foot/*drug therapy
[MESH]
|Disulfides
[MESH]
|Double-Blind Method
[MESH]
|Drug Therapy, Combination
[MESH]
|Female
[MESH]
|Humans
[MESH]
|Ketanserin/pharmacology/therapeutic use
[MESH]
|Male
[MESH]
|Middle Aged
[MESH]
|Pyridones/pharmacology/*therapeutic use
[MESH]
|Sulfinic Acids/pharmacology/therapeutic use
[MESH]
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