Search / Trial NCT06232421

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

Launched by RESEARCH INSTITUTE FOR PHYSICAL CHEMICAL PROBLEMS OF THE BELARUSIAN STATE UNIVERSITY · Jan 22, 2024

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Trial Information

Current as of October 07, 2024

Not yet recruiting

Keywords

Diabetic Foot Infection Chronic Venous Insuffiency Lidocaine Cellulose Miramistin

Description

Diabetes takes the third place in the World in terms of its medical and social significance. Diabetes is often complicated with such urulent-inflammatory processe as diabetic foot syndrome. Urulent-inflammatory processes treatment takes a long time and medications due to microcirculation disorders, metabolic disorders, progressive hypoxia and a number of other factors. A moist wound environment, conducive to the natural process of wound cleansing (autolysis), regeneration of damaged tissue, and reduction of pain, irreversible sorption of excess exudate and toxic components and easy removal ...

Gender

ALL

Eligibility criteria

  • 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 before the current 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, or hepatitis C
  • * Severe liver dysfunction - AST or ALT levels exceed the upper limit of normal by 5 times 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 the protocol requirements for diet, consumption of alcoholic beverages, and medications without the prescription of the research physician.
  • * For reasons independent of the study subject and the research physician, when a study subject develops drug intolerance and other life-threatening or requiring emergency pharmacotherapy adverse reactions to the administration of the study drug.
  • * The need to prescribe drugs from the list of prohibited treatments.

About Research Institute For Physical Chemical Problems Of The Belarusian State University

The Research Institute for Physical Chemical Problems of the Belarusian State University is a leading academic institution dedicated to advancing knowledge in the field of physical chemistry and its applications in health and medicine. With a strong emphasis on interdisciplinary research, the institute fosters innovative approaches to clinical trials, aiming to bridge the gap between scientific discovery and practical healthcare solutions. By leveraging state-of-the-art laboratories and a team of experienced researchers, the institute is committed to conducting high-quality clinical studies that contribute to the understanding and treatment of complex medical conditions, ultimately improving patient outcomes and enhancing public health.

Locations

Minsk, , Belarus

Vitebsk, , Belarus

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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