Improvement in venous ulcer closure and healing with Centellicum®.

Abstract

Background: Venous ulcers are chronic open skin sores, difficult to heal, caused by bad microcirculation in patients with chronic venous insufficiency (CVI) and sustained venous hypertension. In this pilot supplement registry study, the efficacy and safety of oral Centellicum^® (Centella Asiatica standardized extract, Horphag Research) 675 mg/day for 3 months as part of the management of venous ulcerations were evaluated.

Methods: Study endpoints considered measuring the changes in the area of the ulceration and microcirculatory parameters in patients with CVI.

Results: 160 subjects with venous ulcers and CVI completed the study: 80 in the Centellicum^® group, supplemented with 675 mg Centellicum^® per day in addition to the best management treatment (BM) and 80 in the control group with only the BM. The control and treatment groups were comparable for age and sex distribution. Skin resting flux is generally abnormally increased at the peri malleolar region in CVI patients and around ulcerations. Both groups exhibited improvements in microcirculation, skin resting flux (RF) measured with Laser Doppler flowmetry (LDF), transcutaneous PO2 and PCO2. However, the supplementation proved to be more effective than the best management only (P<0.05). After 90 days, the supplement group exhibited a significantly lower number of ulcerations and average ulcer area compared to the control group (P<0.05). In the Centellicum^® group, the ulcer area decreased from 2.34±0.3 cm² to 0.33±0.5 cm², whereas in the control group, it only decreased from 2.4±0.5 cm² to 1.61±0.7 cm². The difference between the two management groups was statistically significant (P<0.021). The rate of completely closed ulcers was 96.2% in the Centellicum^® group, significantly higher than the 83.7% healing rate observed in in the control group. Notably, after just one month, 65% (52/80) of ulcers in the Centellicum^® group had completely healed, compared to only 18.75% (15/80) in the control group. Ulcer closure was the most critical clinical outcome observed.

Conclusions: In venous ulcerations, Centellicum^® supplementation in combination with ulcer management, improved microcirculation parameters and ulcer healing rate. Most of the treatments were done at home by the patients or by their tutors. This study indicates a potential role of Centellicum^® in venous ulcers and CVI and suggests the need to plan larger and more prolonged healing studies.