Two-week topical treatment with Essaven gel in patients with diabetic microangiopathy--a placebo-controlled, randomized study.

The involvement of the microcirculation in diabetic microangiopathy (DM) causes of severe incapacitation and ulceration. DM is characterized by a diffuse increase in flux, reduction in venoarteriolar response, associated with increased permeability resulting in edema and altered function of microlymphatics. In DM, 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) treatment with Essaven gel (EG) in 35 subjects with DM and neuropathy and localized, small (< 0.5 cm in maximum diameter) ulcers treated for 2 weeks. 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. 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 for 2 weeks with standardized application of EG acutely improves the microcirculation in subjects with DM and small ulceration.

RCT Entities:   Population Interventions Outcomes