Patients with non-healing leg ulcers due to severe limb ischemia and who cannot or no longer undergo vascular surgery, have high morbidity and amputation risks.

A device derived from a technology of water soluble engineered biodegradable nano-polymers mimicking heparan sulphates, produced promising results in preclinical models of chronic wounds.

We studied 14 chronic lower-extremity ulcers in 12 patients (median age, 71) TcPO 2 <30 mmHg and ABPI<0.5. At baseline, mean ulcer surface area and duration were 14.15 cm 2 and 7 months respectively. The device was used twice a week and perfectly tolerated.

After 4 weeks ulcer size reduction was 35% (p<0.001) (primary outcome). Increasing to 53% (p<0.001) at 8 weeks as 5 ulcers healed. Pain relief was also noted. RGTA (ReGeneraTing Agents) treatment was prolonged for 6 patients the third months and 2 healed (total 58% patients healed). Follow up for 9 patients indicated that 8 were alive at 12 months, with no ulcer reopening nor amputation nor death linked to treated ulcers.

Matrix protection therapy induced significant ulcer healing to full and stable closure in patients with severe ischemia for whom no other treatment options were available. This unique, simple to use and promising technology provides a new opportunity for unmet therapeutic needs.