First Clinical Pilot Study on critical ischemic leg ulcers with Matrix Therapy ReGeneraTing Agent (RGTA®) technology

摘要: Patients with non-healing leg ulcers due to severe limb ischemia and who cannot or no longer undergo vascular surgery, have high morbidity amputation risks. A device derived from a technology of water soluble engineered biodegradable nanopolymers mimicking heparan sulphates, produced promising results in preclinical models chronic wounds. We studied 14 lower-extremity 12 patients (median age, 71) TcPO 2 <30 mmHg ABPI<0.5. At baseline, mean ulcer surface area duration were 14.15 cm 7 months respectively. The was used twice week perfectly tolerated. After 4 weeks size reduction 35% (p<0.001) (primary outcome). Increasing 53% at 8 as 5 healed. Pain relief also noted. RGTA (ReGeneraTing Agents) treatment prolonged for 6 the third healed (total 58% healed). Follow up 9 indicated that alive months, reopening nor death linked treated ulcers. Matrix protection therapy induced significant healing full stable closure whom other options available. This unique, simple use provides new opportunity unmet therapeutic needs.