NCT06232421

Clinical Study in Adult Patients With Purulent-inflammatory Processes of the Skin and Soft Tissues, Phase I-II of the Wound Process

A Prospective, Parallel, Single-blind Clinical Study Using Stratified Randomization of the Effectiveness, Tolerability and Safety of the Medicinal Product "Foscelantan, Medicinal Plate 4.0x5.0 cm in Package No. 1" Produced by UNITEKHPROM BSU, Republic of Belarus, in Comparison With the Medicinal Product Povidone- Iodine Produced by BelAseptika JSC, in Adult Patients With Purulent-inflammatory Processes of the Skin and Soft Tissues Due to the Neuropathic Form of Diabetic Foot Syndrome or Chronic Venous Insufficiency, Phase I-II of the Wound Process

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 224 (estimated)
• Sponsor: Research Institute for Physical Chemical Problems of the Belarusian State University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to estimate efficiency, tolerance, safety of "Foscelantan, medicinal plate 4.0x5.0 cm in package No. 1" among adult patients who have purulent-inflammatory processes of the skin and soft tissues due to the neuropathic form of diabetic foot syndrome or chronic venous insufficiency, phase I-II of the wound process.

Detailed description

Diabetes takes the third place in the World in terms of its medical and social significance. Diabetes is often complicated with such urulent-inflammatory processe as diabetic foot syndrome. Urulent-inflammatory processes treatment takes a long time and medications due to microcirculation disorders, metabolic disorders, progressive hypoxia and a number of other factors. A moist wound environment, conducive to the natural process of wound cleansing (autolysis), regeneration of damaged tissue, and reduction of pain, irreversible sorption of excess exudate and toxic components and easy removal of the drug from the surface of the wound without additional trauma or damage are yhe main conditions of successful wound healing.Wound dressings made of fibrous polysaccharides modyfied with drugs meet these requirements. Foscelantan has prolonged antimicrobial, analgesic and reparative action, has the ability to transform on the wound surface into an amorphous gel-like mass, irreversibly bind wound detritus and pathological exudate, and provide optimal conditions for the process of wound healing.

Conditions

• Diabetic Foot Infections
• Chronic Venous Insufficiency

Interventions

Type	Name	Description
DRUG	Foscelantan	"Foscelantan, medicinal plate 4.0x5.0 cm in package No. 1" produced by UNITEHPROM BSU, Republic of Belarus
DRUG	Povidon-iodine	Povidone-iodine solution 100 mg/ml produced by BelAseptika CJSC, Republic of Belarus

Timeline

• Start date: 2025-11-01
• Primary completion: 2026-04-01
• Completion: 2026-05-01
• First posted: 2024-01-30
• Last updated: 2025-07-25

Locations

2 sites across 1 country: Belarus