2017
DOI: 10.1155/2017/3159798
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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 t… Show more

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Cited by 28 publications
(25 citation statements)
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References 34 publications
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“…The results of an early study with carboxymethylcellulose dressing suggesting that the intervention improved ulcer depth were not born out by a large outcome blind RCT . Two recent RCTs with topical Pirferidone (with potential anti‐inflammatory/antifibrotic properties) had methodological limitations; neither were blinded, results were analysed per protocol, and there was a high dropout rate in one, and an unexpectedly low healing rate in the control group in the other . Four RCTs of products designed to promote healing; Chitosan and Isosorbide dinitrate, hyaluronic acid, an acellular flowable matrix, and the proteolytic fraction from latex P1G10 provided little support for the use of these agents in clinical practice because of a small number of recruited patients, nonblinding, per protocol analysis, and/or high drop‐out rates.…”
Section: Recommendationsmentioning
confidence: 99%
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“…The results of an early study with carboxymethylcellulose dressing suggesting that the intervention improved ulcer depth were not born out by a large outcome blind RCT . Two recent RCTs with topical Pirferidone (with potential anti‐inflammatory/antifibrotic properties) had methodological limitations; neither were blinded, results were analysed per protocol, and there was a high dropout rate in one, and an unexpectedly low healing rate in the control group in the other . Four RCTs of products designed to promote healing; Chitosan and Isosorbide dinitrate, hyaluronic acid, an acellular flowable matrix, and the proteolytic fraction from latex P1G10 provided little support for the use of these agents in clinical practice because of a small number of recruited patients, nonblinding, per protocol analysis, and/or high drop‐out rates.…”
Section: Recommendationsmentioning
confidence: 99%
“…17 Two recent RCTs with topical Pirferidone (with potential anti-inflammatory/antifibrotic properties) had methodological limitations; neither were blinded, results were analysed per protocol, and there was a high dropout rate in one, 28 and an unexpectedly low healing rate in the control group in the other. 29 Four RCTs of products designed to promote healing; Chitosan and Isosorbide dinitrate, 30 hyaluronic acid, 31 an acellular flowable matrix, 32 and the proteolytic fraction from latex P1G10 33 provided little support for the use of these agents in clinical practice because of a small number of recruited patients, nonblinding, per protocol analysis, and/or high dropout rates. One RCT of a gap-junctional protein (ACT1, a connexin43-based gel) in patients with noninfected neuropathic ulcers showed a significantly greater reduction in mean percent ulcer area from baseline to 12 weeks but with a high rate of withdrawal of consent and protocol noncompliance.…”
Section: Dressings/applications Influencing Chronic Wound Biologymentioning
confidence: 99%
“…It reported superior reduction in ulcer volume with Kitocell‐Q at 3 months (primary outcome), but rates of complete ulcer healing were not different. For a neuropathic DFU cohort, the offloading provided was not described, and rate of healing in both arms was lower than expected …”
Section: Antiseptics Applications and Dressing Productsmentioning
confidence: 86%
“…Another RCT explored the use of Kitocell-Q (gel that combines PFD 8% and M-DDO 0.016%) versus another active comparator, Ketanserin gel, in a small cohort of neuropathic uninfected DFU. 53 It reported superior reduction in ulcer volume with Kitocell-Q at 3 months (primary outcome), but rates of complete ulcer healing were not different. For a neuropathic DFU cohort, the offloading provided was not described, and rate of healing in both arms was lower than expected.…”
Section: Other Topical Productsmentioning
confidence: 96%
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