Fitostimoline® Hydrogel Versus Saline Gauze Dressing in Diabetic Foot Ulcers
The Effects of Fitostimoline® Hydrogel Versus Saline Gauze Dressing in Patients With Diabetic Foot Ulcers: a Monocentric, Two-arm, Open-label, Randomized, Controlled Trial.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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-
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Naples, Italy, 80131
- Department of Clinical Medicine and Surgery Federico II University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: 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.
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Treatment of DFUs with Fitostimoline® hydrogel every day for 12 weeks.
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|
Active Comparator: 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.
|
Treatment of DFUs with saline gauze every day for 12 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the proportion of patients complete responders
Time Frame: 12 weeks
|
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.
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12 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 350/20
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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