A Phase 4 interventional study of Fitostimoline ® hydrogel group and Saline gauze group in Diabetic Foot, sponsored by Federico II University. Completed at 1 site in Italy. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-22.
Sponsored by Federico II University · Phase 4, Interventional, and Treatment
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.
1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's enrollment of 40 is below the median of 60 across 826 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →Federico II University is the lead sponsor of 356 studies on the registry; 60 are open to participants now.
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Exclusion Criteria:
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
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
Treatment of DFUs with Fitostimoline® hydrogel every day for 12 weeks.
Treatment of DFUs with saline gauze every day for 12 weeks.
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.
Time frame: 12 weeks
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Federico II University