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

Inclusion Criteria:

• The presence of purulent-inflammatory processes of the skin and soft tissues due tothe neuropathic form of diabetic foot syndrome (Main diagnosis: Diabetes mellitustype I or II, clinical metabolic compensation/subcompensation, class I - IIaccording to the Wagner classification) or chronic venous insufficiency (Maindiagnosis: Varicose veins dilatation of the veins of the lower extremities, class C6according 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, oncologicaldiseases, as well as diseases requiring steroid therapy

• Availability of written informed consent from the patient to participate in thestudy

• The patient's ability to follow the instructions of the research physician andcomply with the study regimen

Exclusion Criteria:

• Individual intolerance or hypersensitivity reactions to the components of the drugFoscelantan

• Neuroischemic form of diabetic foot syndrome

• The presence of serious concomitant pathology (severe form of renal and hepaticfailure, 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 before thecurrent clinical trial

• Acute bleeding

• Level of peripheral blood leukocytes less than 1.5 × 109 per l, platelets less than 75.0 × 109 per l.

• Hemoglobin less than 80g per l.

• Positive tests for syphilis, human immunodeficiency virus (HIV), hepatitis B, orhepatitis C

• Severe liver dysfunction - AST or ALT levels exceed the upper limit of normal by 5times or more, bilirubin ≥ 2.0 mg/dL (34.2 µmol/L).

• Severe renal dysfunction - creatinine 2 times higher than reference values

• Diabetes mellitus in a state of clinical and metabolic decompensation

• Pregnant and breastfeeding women

• At one's own request without explaining the reasons for the action.

• At the request of the research physician, if the research subject violates theprotocol requirements for diet, consumption of alcoholic beverages, and medicationswithout the prescription of the research physician.

• For reasons independent of the study subject and the research physician, when astudy subject develops drug intolerance and other life-threatening or requiringemergency pharmacotherapy adverse reactions to the administration of the study drug.

• The need to prescribe drugs from the list of prohibited treatments.