Microvascular alterations in diabetic microangiopathy: topical treatment with Essaven gel--a placebo-controlled, randomized study.

The involvement of the microcirculation in diabetic microangiopathy (DM) may be cause of severe invalidity and ulceration. Diabetic microangiopathy (DM) is characterized by a diffuse increase in skin flux, reduction in venoarteriolar response, and increased capillary permeability resulting in edema; skin PO2 is decreased and CO2 increased. In this condition, capillary exchanges are altered and nutritional alterations eventually lead to skin lesions and ulcers. The aim of this randomized, placebo-controlled study was to evaluate the effect of local foot care and treatment with Essaven gel (EG) in 30 subjects with DM and neuropathy and localized, small (<0.5 cm in maximum diameter) ulcers treated with a single acute application of EG. Measurements of laser Doppler (LDF) flux, PO2 and PCO2 in standardized conditions showed positive microcirculatory changes (a significant decrease of the abnormally increased flux and CO2 while PO2 increased) in the active EG group lasting for at least 6 hours after application. Changes in the control group were not significant. In the placebo group variations were limited, mainly associated with skin manipulation and gel application. In conclusion, local treatment with one single standardized application of Essaven gel, in comparison with placebo, acutely improves the microcirculation in subjects with DM and small ulceration even with a single acute application. The microcirculatory changes are detectable even 10 hours after application.

RCT Entities:   Population Interventions Outcomes