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A prospective, randomized, controlled, clinical study to establish clinical based evidence of Eclipse PRP™ and compare its performance with the usual and customary practice for the treatment of Wagner 1 or 2 DFUs.
Re: Platelet rich plasma and diabetic foot ulcer healing
Case series of patients with chronic foot ulcers treated with autologous platelet-rich plasma.
Yotsu RR, Hagiwara S, Okochi H, Tamaki T. J Dermatol. 2015 Jan 23.
Treatment for patients with chronic wounds is entering a new era, and autologous platelet-rich plasma (PRP) is among the most promising treatments. PRP contains a concentration of platelets obtained by centrifuging the patient's blood. Because it contains fibrin and high concentrations of growth factors, PRP is known to promote wound healing. In this study, we present five patients with chronic foot ulcers successfully treated with PRP in our institution. The patients had various underlying diseases: diabetes (n = 2), peripheral arterial disease (n = 1), both diabetes and peripheral arterial disease (n = 1), and cutaneous polyarteritis nodosa (n = 1). Also, we provide a description of PRP's mechanisms, advantages, and limitations.
Lower extremity ulcers and amputations are an increasing problem among individuals with diabetes. Among diabetes mellitus-related complications, foot ulceration is the most common, affecting approximately 15% of diabetic patients during their lifetime. The pathogenesis of diabetic ulcer is peripheral sensory neuropathy, calluses, oedema and peripheral vascular disease. Diabetic ulcer is managed by adequate control of infections and blood sugar levels, surgical debridement with various dressings and off loading of the foot from pressure. In spite of these standard measures, some recalcitrant non-healing ulcers need additional growth factors for healing. Autologous platelet-rich plasma is easy and cost-effective method in treating diabetic ulcers as it provides necessary growth factors which enhance healing.
We sought to investigate the effect of autologous platelet-rich plasma (PRP) on the healing rate of diabetic foot ulcers in patients with diabetes and concomitant peripheral arterial disease (PAD). Diabetic patients with foot ulceration presenting with PAD who were treated with local growth factors in a single center, during a 24-month period from May 2009 to April 2011, were retrospectively reviewed. Based on the severity of PAD, subjects were divided into groups A (Fontaine classification stages I, IIa, and IIb) and B (Fontaine classification stages III and IV), with those included in the latter being considered to suffer from critical limb ischemia (CLI). End points of the analysis were clinical improvement, limb salvage, and amputation rate. Outcome was compared between groups A and B. Overall, 72 patients were evaluated, 30 with CLI. Ulcer area reduction >50% was observed in 58/72 patients while reduction >90% was achieved in 52/72 patients. There were 14 (19%) major and minor amputations, whereas the limb salvage rate was 89%. This variable was significantly different between groups A and B (100% vs 73%, P < .001), as is rate of reduction in ulcer area >90% (83% vs 56%, P = .02). Reduction of ulcer area >50% was observed in the majority of patients in both groups (group A 86% vs group B 73%, P = .23). In conclusion, PRP could serve as a useful adjunct during management of diabetic foot ulcers even in diabetic patients with unreconstructable arterial disease.
Re: Platelet rich plasma and diabetic foot ulcer healing
Topical Platelet-Derived Growth Factor vs Placebo Therapy of Diabetic Foot Ulcers Offloaded With Windowed Casts: A Randomized, Controlled Trial.
Ma C, Hernandez MA, Kirkpatrick VE, Liang LJ, Nouvong AL, Gordon II Wounds. 2015 Apr;27(4):83-91.
This study sought to compare the efficacy of topical platelet derived growth factor (Regranex, Smith and Nephew, London, UK) (test group) to placebo (control group) in treating diabetic foot ulcers. All subjects had a short leg walking cast with a window fashioned in the cast over the site of the ulcer.
Forty-six subjects were randomized (double-blind) 1:1 to the test or control group and treated for up to 4 months. Subjects had Wagner grade I ulcers with wound area of 1 cm2 to 16 cm2 without severe peripheral arterial disease, osteomyelitis, or any infection requiring antibiotics. Study medication was applied daily and casts changed approximately every 14 days.
Of the 46 subjects randomized, 38 either healed or completed 16 weeks of therapy without healing. Eight subjects dropped out prior to 16 weeks. Based on intention-to-treat, 12 of 23 (52%) test group subjects healed before 16 weeks compared to 13 of 23 (57%) control group subjects (not significant). Regression analysis demonstrated that slower healing was associated with larger initial wound size (hazard radio [HR] = 0.997, 95% confidence interval [CI]: 0.995-1.00, P = 0.028) and excessive wound drainage (HR = 0.346, 95% CI: 0.126-0.948, P = 0.039). Excluding the patients who dropped out, 25 of 38 (66%) subjects healed by 4 months. Three additional subjects healed with casts that were worn longer than 4 months, for an overall rate of 74% at 9 months. Five subjects developed cast burns, and 3 patients required amputation.
Topical platelet derived growth factor does not appear to significantly improve healing of Wagner grade I diabetic foot ulcers that are treated by offloading with a short leg walking cast. Excellent healing rates may be achieved with casting alone.