Topical treatment of venous microangiopathy in patients with venous ulceration 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 ulceration. VHM is characterized by enlarged, convoluted capillaries; microvascular thrombosis; obliteration of some capillaries; increase in flux, permeability, and edema and altered 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 increased exchange surface of capillaries, which become tortuous and glomerular-like. The aim of this randomized, placebo-controlled study was to evaluate local treatment with Essaven gel (EG) in subjects with venous microangiopathy and ulcers. Measurements of laser Doppler flux, PO2, and PCO2 in standardized conditions showed positive changes (a 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 acute application.
De Sanctis
M T
MT
Irvine2 Vascular Laboratory, Department of Biomedical Sciences, Chieti University and San Valentino Vascular Screening Project, Italy.
Incandela
L
L
Belcaro
G
G
Cesarone
M R
MR
D000287:Administration, Topical; D004311:Double-Blind Method; D004338:Drug Combinations; D004928:Escin / Q000008:administration & dosage*; D005343:Fibrinolytic Agents / Q000008:administration & dosage*; D006493:Heparin / Q000008:administration & dosage*; D006801:Humans; D008875:Middle Aged; D010743:Phospholipids / Q000008:administration & dosage*; D014647:Varicose Ulcer / Q000188:drug therapy*; D014689:Venous Insufficiency / Q000188:drug therapy*
D004338:Drug Combinations; D005343:Fibrinolytic Agents; D010743:Phospholipids; D004928:Escin; C013980:Essaven Gel; D006493:Heparin