Changes in microcirculation in venous ulcers with Essaven gel--a pilot, cross-over, placebo-controlled, randomized study.
Microcirculatory changes in chronic venous insufficiency (CVI) due to venous hypertension produce venous hypertensive microangiopathy (VHM) and lead to ulceration. VHM is characterized by enlarged, convoluted capillaries; increase in flux, permeability, and edema; and altered microlymphatics. PO2 is decreased and CO2 increased. Capillary exchanges are altered and nutritional alterations in association with microtrauma may cause venous ulcers. The aim of this pilot, cross-over, randomized, placebo-controlled study was to evaluate the effect of local treatment with Essaven gel (EG) (single acute application) in 10 subjects with VHM and venous ulcers. The study was structured over 3 days: day 1 was used for the control evaluation for all patients. One group was randomized for the sequence placebo (day 2) and EG the following day; the second group with the sequence EG (day 2) and placebo (day 3). Independently from the sequence, measurements of flux and PO2 in standard conditions showed positive changes (significant decrease of the abnormally increased flux, PO2 increase) in the EG treatment group. Changes in the placebo group were limited and associated with skin manipulation. In conclusion, EG acutely improves microcirculation in limbs with VHM and ulceration 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; D018592:Cross-Over Studies; 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 / Q000188:drug therapy; D008297:Male; D008833:Microcirculation / Q000187:drug effects*; D008875:Middle Aged; D010743:Phospholipids / Q000008:administration & dosage*; D010865:Pilot Projects; D016896:Treatment Outcome; D014647:Varicose Ulcer / Q000188:drug therapy*
D004338:Drug Combinations; D005343:Fibrinolytic Agents; D010743:Phospholipids; D004928:Escin; C013980:Essaven Gel; D006493:Heparin