Fitostimoline® Hydrogel Versus Saline Gauze Dressing in Diabetic Foot Ulcers

• Status: Completed
• Trial end date: 2022-12-12
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Federico II University

Criteria

Inclusion Criteria:

• Type 1 diabetes and type 2 diabetes,

• adult patients with DFUs at Grades IC or IIC for a period of at least 12 weeks,

• an akle brachial index >0.8,

• be able to understand simple instructions,

• provided voluntary, signed informed consent

Exclusion Criteria:

• active infection

• evidence of ischaemia in the limb,

• osteomyelitis,

• gangrene,

• systemic inflammatory or autoimmune disease,

• use of corticosteroids, immunosuppressive agents, radiation therapy and chemotherapyan,

• known hypersensitivity to any of the dressing components.