Fitostimoline® Hydrogel Versus Saline Gauze Dressing in Diabetic Foot Ulcers
Status:
Completed
Trial end date:
2022-12-12
Target enrollment:
Participant gender:
Summary
Diabetes Mellitus (DM) is one of the most widespread metabolic diseases and the alarming rise
in its prevalence worldwide poses enormous challenges. The microvascular and macrovascular
complications of DM heavy impact on longevity and quality of life, and in particular diabetic
foot ulcers (DFUs) are among the ten top causes of worldwide disease burden and disability
Essential components of the standard care, management, and treatment of DFUs are represented
by health education, strict control of blood glucose and cardiovascular risk factors,
offloading, local debridement, and adequate dressing. A wide variety of dressing is
available, and these include basic contact dressings (low adherence dressings such as saline
gauze, paraffin gauze or simple absorbent dressings) and advanced dressings (alginate,
hydrogel, films, hydrocolloid, foam).
It is important underline that due to lack of evidence from head-to-head randomized
controlled trials (RCTs), the relative effects of any of these dressings in DFUs remain
unclear. Consequently, so far clinical evidence supporting the choice for either hydrogel or
saline gauze dressing, has been related mostly on clinician perception rather than high
quality evidence. Here we evaluated the efficacy and safety of Fitostimoline® hydrogel
dressing versus saline gauze dressing in patients with DFUs in a monocentric, two-arm,
open-label, randomized, controlled trial.