Pilot Wound Healing Study in the treatment of Diabetic Ulcers

Abstract This clinical study was initiated as a result of physician feedback showing wound healing potential from use of an Alginate Hydrogel product FDA 510k approved in 1998. It was designed to test the hypothesis that the Alginate Hydrogel dressing facilitated the healing of diabetic ulcers at a greater rate than the Hydrogel vehicle alone, and that the fragrant botanical base used to impart a pleasant fragrance, might be the source of the perceived positive clinical effect. A 21-patient, 8-week comparative study evaluated the accelerated wound healing potential of the Alginate Hydrogel dressing, the Hydrogel vehicle (placebo control) and becaplermin gel 0.01% (active control) in the treatment of diabetic ulcers. ANOVA was used to analyze wound length, width, depth and global scores for epithelialization and granulation. A primary wound efficacy measure is % epithelialization of the wound. When change from baseline to week 8 for the parameter of global evaluation score for epithelialization was analyzed, the Alginate Hydrogel dressing demonstrated a statistically significant mean difference of -2.571 when compared to the Hydrogel vehicle and a statistically significant mean difference of -2.571 when compared to the becaplermin gel. The average daily per patient cost of treatment medication and supplies for the becaplermin gel ($15.05/day) was 2.3 times more than the Alginate Hydrogel ($6.56/day). The Alginate Hydrogel dressing demonstrated both accelerated wound healing and more cost effectiveness when compared to becaplermin gel in patients with late stage diabetic ulcers