Fitostimoline® Hydrogel Versus Saline Gauze Dressing in Diabetic Foot Ulcers

Diabetic Foot Clinical Trial

Official title:

The Effects of Fitostimoline® Hydrogel Versus Saline Gauze Dressing in Patients With Diabetic Foot Ulcers: a Monocentric, Two-arm, Open-label, Randomized, Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05661474
• Other study ID #: 350/20
• Status: Completed
• Phase: Phase 4
• Start date: February 1, 2021
• Est. completion date: December 12, 2022

Study information

• Verified date: December 2022
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 12, 2022
• Est. primary completion date: July 12, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Foot
• Foot Ulcer

Intervention

Drug:
• Fitostimoline ® hydrogel group
Treatment of DFUs with Fitostimoline® hydrogel every day for 12 weeks.
• Saline gauze group
Treatment of DFUs with saline gauze every day for 12 weeks.

Locations

Country	Name	City	State
Italy	Department of Clinical Medicine and Surgery Federico II University	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the proportion of patients complete responders	The primary outcome was the proportion of patients that at the end of study period of 12 weeks (V6) were categorized as complete responders -complete healing of the wound defined as reepithelialisation of 100% without medications.	12 weeks