Clinical Study in Adult Patients With Purulent-inflammatory Processes of the Skin and Soft Tissue… (NCT06232421) | Clinical Trial Compass
Not Yet RecruitingPhase 2/3
Clinical Study in Adult Patients With Purulent-inflammatory Processes of the Skin and Soft Tissues, Phase I-II of the Wound Process
Belarus224 participantsStarted 2025-11
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion Criteria:
* The presence of purulent-inflammatory processes of the skin and soft tissues due to the neuropathic form of diabetic foot syndrome (Main diagnosis: Diabetes mellitus type I or II, clinical metabolic compensation/subcompensation, class I - II according to the Wagner classification) or chronic venous insufficiency (Main diagnosis: Varicose veins dilatation of the veins of the lower extremities, class C6 according to the CEAP classification), phase I-II of the wound process
* The size of the ulcerative defect is from 1 cm² to 20 cm²
* Secondary type of wound healing
* Absence of exposed bones and tendons in the wound
* Absence of severe concomitant diseases in the stage of decompensation, oncological diseases, as well as diseases requiring steroid therapy
* Availability of written informed consent from the patient to participate in the study
* The patient's ability to follow the instructions of the research physician and comply with the study regimen
Exclusion Criteria:
* Individual intolerance or hypersensitivity reactions to the components of the drug Foscelantan
* Neuroischemic form of diabetic foot syndrome
* The presence of serious concomitant pathology (severe form of renal and hepatic failure, systemic connective tissue diseases, severe cardiovascular insufficiency), history and current mental illness
* The need to constantly take drugs from the list of prohibited therapies
* Participation of the patient in another clinical trial within 3 months b…
What they're measuring
1
Number of patients with trophic ulcers cured
Timeframe: 15 days
Trial details
NCT IDNCT06232421
SponsorResearch Institute for Physical Chemical Problems of the Belarusian State University