Macrophage stimulating agent soluble yeast β-1,3/1,6-glucan as a topical treatment of diabetic foot and leg ulcers: A randomized, double blind, placebo-controlled phase II study.

ABSTRACT:

Aims/introduction

Dysregulated inflammatory response is believed to be an important factor in the pathogenesis of several late complications of diabetes mellitus. β-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 β-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

SUBMITTER: Zykova SN 

PROVIDER: S-EPMC4210076 | biostudies-literature | 2014 Jul

REPOSITORIES: biostudies-literature