About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Foscelantan
- Povidon-iodine
Treatment groups
Sponsors and collaborators
Research Institute for Physical Chemical Problems of the Belarusian State University
Lead sponsor
Vitebsk Regional Clinical Hospital
Collaborator
Unitary Enterprise UNITEHPROM BSU
Collaborator
The 10th Minsk City Clinical Hospital
Collaborator