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 range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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