A Prospective Cohort Study of Hard-to-Heal Chronic Foot and Leg Wounds Followed for up to 20 Weeks After Initiation of ReGenerating Tissue Agents (RGTA) Technology as an Add-on to Optimal Local Care.

ReGenerating Tissue Agents (RGTA, trade name CACIPLIQ20) contain a structural analogue of heparan sulfates (HSs) that promotes tissue regeneration in hard-to-heal chronic wounds resistant to the best standard of care for 6 months or longer. The MATHCOW study aimed to evaluate the real-life performance and safety of RGTA administered in addition to optimal treatment in diabetic foot ulcers (DFUs), venous leg ulcers (VLUs), and leg ulcers with an ischemic component (arterial ulcers). The primary outcome measure was the rate of ulcer closure within the first 20 weeks of treatment. A total of 191 patients were recruited; 173 signed informed consent and constituted the intention-to-treat (ITT) analysis set. The per-protocol (PP) population included 114 patients. The primary endpoint was 50 wound closures at 20 weeks in the ITT analysis (28.9%) and 46 wound closures in the PP analysis (40.4%). Closure rates varied according to ulcer type: 43.7% for VLUs, 46.2% for DFUs, and 14.6% for arterial ulcers. Other endpoints also improved, including clinician global impression, pain, and ulcer area. Adverse events were recorded in 4% of cases. This open-label study confirms the performance and tolerability of RGTA in a population of patients with particularly hard-to-heal chronic ulcers.