ProgenaMatrix™ is currently being evaluated in select high-volume wound clinics, in the venous leg ulcer (VLU) patient population.1 The purpose of this clinical study is to evaluate wound healing efficacy and mechanisms of action, as well as safety. The goal of the study is to enroll 20-25 patients and evaluate wound healing against historical controls.
Venous leg ulcers are a common problem in patients with venous insufficiency. Approximately 7 million people in the U.S. have venous insufficiency and it’s estimated that 1 million people will develop VLU. These VLU wounds often recur, and the wounds can persist for weeks, months or even years, potentially leading to complications such as cellulitis, osteomyelitis or malignant change.2
The study is being led by Thomas E. Serena, MD, FACS, FACHM, MAPWCA, at SerenaGroup, in Hingham, MA.
1. Western Institutional Review Board
2. Agale SV. Chronic leg ulcers: epidemiology, aetiopathogenesis and Management. Hindawi Publishing Corporation 2013;13:Article ID 413604:9 pages
ProgenaMatrix is currently undergoing a 510k premarket review by FDA for dry, light and moderately exuding partial and full thickness wounds. Not available for sale or other clinical use.