Microangiopathy and venous ulceration: topical treatment with Essaven gel--a placebo-controlled, randomized study.
The involvement of the microcirculation in chronic venous insufficiency (CVI) due to venous hypertension causes venous hypertensive microangiopathy (VHM) and venous ulceration. VHM is characterized by the presence of enlarged convoluted capillaries; microvascular thrombosis with obliteration of some capillaries; increase in flux, permeability, and edema; and altered function of microlymphatics. PO2 is decreased and CO2 increased. Capillary exchanges are altered, and nutritional alterations eventually lead to venous ulcers. Edema is associated with increased capillary pressure, reduced clearance, and an increased exchange surface of capillaries, which become tortuous and glomerular-like. The aim of this randomized, placebo-controlled study was to evaluate the effect of local treatment with Essaven gel (EG) in 28 subjects with venous microangiopathy due to severe CVI and ulcers treated with a single acute application, Measurements of laser Doppler flux, PO2 and PCO2 in standardized conditions of application showed positive microcirculatory changes (significant decrease of the abnormally increased flux and CO2 while PO2 increased) in the EG treatment group. Changes in the placebo and control group were more limited (changes in the placebo group were mainly associated with skin manipulation when placebo-EG was applied). In conclusion, Essaven gel, in comparison with placebo, acutely improves the microcirculation in VHM even with a single application.
Incandela
L
L
Irvine2 Vascular Laboratory, Department of Biomedical Sciences, Chieti University and San Valentino Vascular Screening Project, Italy.
Belcaro
G
G
Cesarone
M R
MR
De Sanctis
M T
MT
Griffin
M
M
D000287:Administration, Topical; D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D004338:Drug Combinations; D004928:Escin / Q000008:administration & dosage*; D005260:Female; D005343:Fibrinolytic Agents / Q000008:administration & dosage*; D006493:Heparin / Q000008:administration & dosage*; D006801:Humans; D006973:Hypertension / Q000150:complications; D008297:Male; D008833:Microcirculation / Q000187:drug effects; D008875:Middle Aged; D016491:Peripheral Vascular Diseases / Q000188:drug therapy*; D010743:Phospholipids / Q000008:administration & dosage*; D014647:Varicose Ulcer / Q000188:drug therapy*; D014689:Venous Insufficiency / Q000150:complications
D004338:Drug Combinations; D005343:Fibrinolytic Agents; D010743:Phospholipids; D004928:Escin; C013980:Essaven Gel; D006493:Heparin