Fitostimoline® Hydrogel Versus Saline Gauze Dressing in Diabetic Foot Ulcers

NCT ID: NCT05661474

Last Updated: 2022-12-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2022-12-12

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fitostimoline® hydrogel group

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.

Group Type: EXPERIMENTAL

Fitostimoline ® hydrogel group

Intervention Type: DRUG

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

Saline gauze group

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.

Group Type: ACTIVE_COMPARATOR

Saline gauze group

Intervention Type: DRUG

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

Interventions

Fitostimoline ® hydrogel group

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

Intervention Type: DRUG

Saline gauze group

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

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Federico II University

OTHER

Sponsor Role: lead

Responsible Party

rivellese angela

Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Clinical Medicine and Surgery Federico II University

Naples, , Italy

Countries

Italy

Other Identifiers

350/20

Identifier Type: -

Identifier Source: org_study_id