Fitostimoline® Hydrogel Versus Saline Gauze Dressing in Diabetic Foot Ulcers

NCT05661474 | Completed Phase 4

• 1 other identifier: 350/20
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetic Foot

Keywords

diabetic foot; dressing; medication

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Fitostimoline® hydrogel group

EXPERIMENTAL

Participant randomized to the Fitostimoline® hydrogel group underwent sharp surgical debridement at each visit (every 2 weeks) to remove necrotic tissue and slough. After debridement operation, was performed disinfection with povidone-iodine, and cleansing with sterile saline solution. Then was applaied Fitostimoline ® hydrogel, finally the wound was covered with gauze.

Drug: Fitostimoline ® hydrogel group

Saline gauze group

ACTIVE COMPARATOR

Participant randomized to the Saline gauze group underwent sharp surgical debridement at each visit (every 2 weeks) to remove necrotic tissue and slough. After debridement operation, was performed disinfection with povidone-iodine, and cleansing with sterile saline solution. Then was applaied saline gauze, finally the wound was covered with gauze.

Drug: Saline gauze group

Interventions

Fitostimoline ® hydrogel group DRUG

Treatment of DFUs with Fitostimoline® hydrogel every day for 12 weeks.

Fitostimoline® hydrogel group

Saline gauze group DRUG

Treatment of DFUs with saline gauze every day for 12 weeks.

Saline gauze group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Department of Clinical Medicine and Surgery Federico II University

Naples, 80131, Italy

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: December 12, 2022
• First Posted: December 22, 2022
• Study Start: February 1, 2021
• Primary Completion: July 12, 2022
• Study Completion: December 12, 2022
• Last Updated: December 22, 2022

Record last verified: 2022-12

Locations

IT (1)