A Single Center, Randomized Controlled Trial on the Efficacy of Topical Application of ReGenerating Tissue Agents (RGTA) Technology in Diabetic Foot Ulcers

Abstract

Diabetic foot ulcers (DFUs) are a serious complication of diabetes mellitus. Clinical data from the use of ReGenerating Tissue Agents (RGTA) technology in patients with DFUs are scarce. The objective of this randomized controlled study was to evaluate the efficacy of RGTA technology in the management of DFUs. Patients with chronic, neuroischemic diabetic foot ulcers were randomized 1:1 to the control group, that received the standard of care, and to the intervention group, that additionally received RGTA twice per week. The duration of the intervention was 12 weeks. Skin biopsies for histological and immunohistochemical analyses from a sample of participants were also performed. About 31 patients completed the study. Five (31.2%) patients in the intervention group achieved complete healing at the end of the intervention period versus 0 patients in the control group ( P = .043), [RR: 0.688 (95% CI: 0.494-0.957)]. The intervention group had more ulcers with at least 80% healing of their surface [10 (66.7%) versus 2 (13.3%), P = .008, RR: 0.385 (95% CI: 0.183-0.808)], higher absolute surface reduction [1.5 (0.7, 5.2) versus 0.6 (0.3, 1.0), P = .026] and higher percentages of surface reduction [94 (67, 100) versus 40 (26, 75), P = .001] at the end of the intervention period. More patients in the intervention group achieved at least 50% healing at the fourth week of the study [9 (64.3%) versus 2 (14.3%) P = .018, RR: 0.417 (95% CI: 0.200-0.869)]. Immunohistochemical analyses were performed in a sample of participants that revealed higher expression of CD163, COL3 and VEGFR in the intervention group. The adverse effects were similar between the 2 groups. The data from the present study suggest that the adjunction of RGTA technology in the management of diabetic foot ulcers is a safe practice that promotes wound healing.