MEDICAL-SOCIAL SIGNIFICANCE OF BETA-1,3/1,6-GLUCAN USE FOR LOCAL IMMUNOMODULATORY THERAPY IN TREATMENT OF TROPHIC ULCERS OF LOWER EXTREMITIES IN DIABETES MELLITUS
The aim of the study was to reveal the effects of local immunomodulatory therapy on healing of wounds in patients with chronic diabetic foot ulcers upon inclusion of local treatment with beta-1,3/1,6-D-polyglucose into the conventional management scheme, as well as to evaluate safety, tolerability and medical-social meaning of this potential treatment. Double blind, placebo-controlled study was undertaken during 12 weeks and was consist of evaluation of local treatment trophic ulcers after surgical debridement in day. Patients were randomized in two groups with the help of group randomization with casual sample size (22 - in "glucan" group and 24 - in control). The ulcers were measured every visit and laboratory analyses were performed. All the patients received the following therapy: foot off-loading; 3 courses of antibacterial therapy; local treatment, glycemia corrections. In conclusion, local treatment of trophic lower extremity ulcers with beta-1,3/1,6-polyglucose significantly improved the rate of wound closure in patients diabetes mellitus against placebo therapy. During treatment there were no adverse events than confirms its safety use. Inclusion of beta-1,3/1,6-polyglucose in clinical practice has great medical-social meaning in patients with diabetic foot syndrome, as increasing of efficacy of therapy in spite of economic effect positively influences on quality of life and reduces amputation risk and patients' invalidisation.