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

Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorResearch Institute for Physical Chemical Problems of the Belarusian State University

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

224 Participants
are divided into 4 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