Macrophage stimulating agent soluble yeast ?-1,3/1,6-glucan as a topical treatment of diabetic foot and leg ulcers: A randomized, double blind, placebo-controlled phase II study.
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ABSTRACT: AIMS/INTRODUCTION:Dysregulated inflammatory response is believed to be an important factor in the pathogenesis of several late complications of diabetes mellitus. ?-Glucans are potent inducers of immune function. The present randomized, double blind, two-center, placebo-controlled study was undertaken to explore safety, tolerability and efficacy of soluble ?-1,3/1,6-glucan (SBG) as a local treatment of diabetic foot ulcers. MATERIALS AND METHODS:A total of 60 patients with type 1 or 2 diabetes and lower extremity ulcers (Wagner grade 1-2, Ankle/Brachial Index ?0.7) received SBG or a comparator product (methylcellulose) locally three times weekly up to 12 weeks in addition to conventional management scheme. A total of 54 patients completed the study. RESULTS:A tendency for shorter median time to complete healing in the SBG group was observed (36 vs 63 days, P = 0.130). Weekly percentage reduction in ulcer size was significantly higher in the SBG group than in the methylcellulose group between weeks 1-2, 3-4 and 5-6 (P < 0.05). The proportion of ulcers healed by week 12 was also in favor of SBG (59% vs 37%, P = 0.09), with a significantly higher healing incidence in the SBG group at week 8 (44% vs 17%, P = 0.03). SBG was safe and well tolerated. There was a clinically significant difference regarding the incidence of serious adverse events in favor of the SBG treatment. CONCLUSIONS:Local treatment of diabetic lower extremity ulcers with ?-1,3/1,6-polyglucose shows good safety results. This ?-glucan preparation shows promising potential as a treatment accelerating cutaneous healing. Further studies are required to confirm this effect. This trial was registered with ClinicalTrials.gov (no. NCT00288392).
SUBMITTER: Zykova SN
PROVIDER: S-EPMC4210076 | biostudies-literature | 2014 Jul
REPOSITORIES: biostudies-literature
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