Extract and Polyhexanide (Fitostimoline Hydrogel/Fitostimoline Plus Gauze) versus Saline Gauze Dressing in Patients with Diabetic Foot Ulcers: Results of a Randomized Controlled Trial.

Background: The use of dressings is an essential component of the standard of care for diabetic foot ulcers (DFUs); however, despite the wide variety of dressings available, there is a lack of evidence from head-to-head randomized controlled trials. We evaluated the efficacy and safety of extract and polyhexanide (Fitostimoline hydrogel/Fitostimoline Plus gauze) versus saline gauze dressings in patients with DFUs.

Methods: This study involved a monocentric, two-arm, open-label, controlled trial in patients with DFUs (Grades I or II, Stage A or C, based on the Texas classification) randomized to 12 weeks of dressing with Fitostimoline hydrogel/Fitostimoline Plus gauze or saline gauze.