A Randomized Controlled Trial: Effects of Alginate Gel in the Treatment of Diabetic Foot Ulcers

Background: Diabetic Foot Ulcers (DFUs) are among the many complications associated with diabetes over time.Therefore, it is particularly urgent and necessary to study the intrinsic causes of foot ulcer healing, optimize existing treatment protocols further, and actively explore effective early prevention and treatment. Methods:The study was a randomized controlled trial in which participants were randomized (1:1) to either the Alginate Care or the placebo arm.The study treatment with Alginate Care or placebo gel started at the baseline visit.The study gel (Alginate Care group) or matrix-matched placebo was applied directly to the wound bed using aseptic technique to form a complete coverage layer and extend a 1-cm coated area to the surrounding healthy skin, and after the gel had cured to form a pliable protective film, an inert standardized dressing was superimposed for secondary coverage, with dressing change intervals adjusted according to the amount of wound exudate to ensure that standardized care procedures were carried out at least 2-3 times per week.In patients with multiple wounds, the largest ulcer2 cm from other lesions was selected as the target wound.The primary outcome was wound closure (100% epithelialization of the wound, no drainage, no suture material, no wound dressing or adjuvant required).Results: After 12 weeks of treatment, 7 of 40 wounds (17.5%) healed in the Alginate Care group compared with 2 of 40 (7.5%) in the placebo group. Conclusion:In conclusion, the findings of this study provide strong evidence supporting the efficacy of Alginate Care in promoting wound healing.The significant improvements observed across multiple outcome measures suggest that Alginate Care has the potential to become a standard-of-care in wound management, offering hope for better patient outcomes and a new direction for wound care research and development.