Clinical Study in Adult Patients With Purulent-inflammatory Processes of the Skin and Soft Tissues, Phase I-II of the Wound Process (OLENKRON-01)

A Prospective, Parallel, Single-blind Clinical Study Using Stratified Randomization of the Effectiveness, Tolerability and Safety of the Medicinal Product "Foscelantan, Medicinal Plate 4.0x5.0 cm in Package No. 1" Produced by UNITEKHPROM BSU, Republic of Belarus, in Comparison With the Medicinal Product Povidone- Iodine Produced by BelAseptika JSC, in Adult Patients With 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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Venous Insufficiency; Diabetic Foot Infections
• Intervention / Treatment: Drug: Foscelantan; Drug: Povidon-iodine

Detailed 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 of the drug from the surface of the wound without additional trauma or damage are yhe main conditions of successful wound healing.Wound dressings made of fibrous polysaccharides modyfied with drugs meet these requirements. Foscelantan has prolonged antimicrobial, analgesic and reparative action, has the ability to transform on the wound surface into an amorphous gel-like mass, irreversibly bind wound detritus and pathological exudate, and provide optimal conditions for the process of wound healing.

• Study Type: Interventional
• Enrollment (Estimated): 224
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Eugen Grinyuk, Ph.D., Associate professor; Phone Number: +375 17 209-52-54; Email: hryniuk@bsu.by
• Study Contact Backup: Name: Pavel Bychkovsky, Ph.D., Associate Professor; Phone Number: +375 17 209-58-40; Email: bychkovsky@tut.by

Study Locations

• Belarus
  • Minsk, Belarus, 220096
    • 10th CITY CLINICAL HOSPITAL
    • Contact: Viktor Isachkin; Phone Number: +375173419811; Email: info@10gkb.by
    • Contact: Mihail Shkoda; Phone Number: +375447628662; Email: info@10gkb.by
    • Principal Investigator: Mihail Shkoda
    • Sub-Investigator: Natalja Mihajlova
  • Vitebsk, Belarus, 210037
    • Health care institution Vitebsk Regional Clinical Hospital
    • Contact: Evgenij Matusevich; Phone Number: +375339901777; Email: info@vokb.by
    • Contact: Uladislau Zjuzenko; Phone Number: +375212689267; Email: info@vokb.by
    • Principal Investigator: Uladislau Zjuzenko
    • Sub-Investigator: Aleksandr Glyzdov
    • Sub-Investigator: Evgenij Matusevich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with the neuropathic form. Treatment with Foscelantan; A prospective, parallel, single-blind clinical study using stratified randomization of the effectiveness, tolerability and safety of the drug "Foscelantan, medicinal plate 4.0×5.0 cm in package No. 1" produced by UNITEHPROM BSU, Republic of Belarusin adult patients with purulent-inflammatory processes of the skin and soft tissues due to the neuropathic form of diabetic foot syndrome, phase I-II wound process. All patients will receive systemic traditional therapy for the underlying and concomitant diseases.	Drug: Foscelantan; "Foscelantan, medicinal plate 4.0x5.0 cm in package No. 1" produced by UNITEHPROM BSU, Republic of Belarus
Active Comparator: Patients with the neuropathic form. Treatment with Povidone-iodine; A prospective, parallel, single-blind clinical study using stratified randomization of the effectiveness, tolerability and safety of the drug Povidone-iodine produced by BelAseptika JSC, in adult patients with purulent-inflammatory processes of the skin and soft tissues due to the neuropathic form of diabetic foot syndrome, phase I-II wound process. All patients will receive systemic traditional therapy for the underlying and concomitant diseases.	Drug: Povidon-iodine; Povidone-iodine solution 100 mg/ml produced by BelAseptika CJSC, Republic of Belarus
Experimental: Patients with chronic venous insufficiency. Treatment with Foscelantan; A prospective, parallel, single-blind clinical study using stratified randomization of the effectiveness, tolerability and safety of the drug "Foscelantan, medicinal plate 4.0×5.0 cm in package No. 1" produced by UNITEHPROM BSU, Republic of Belarus in adult patients with purulent inflammatory processes of the skin and soft tissues due to chronic venous insufficiency," phase I-II of the wound process. All patients will receive systemic traditional therapy for the underlying and concomitant diseases.	Drug: Foscelantan; "Foscelantan, medicinal plate 4.0x5.0 cm in package No. 1" produced by UNITEHPROM BSU, Republic of Belarus
Active Comparator: Patients with chronic venous insufficiency. Treatment with Povidone-iodine; A prospective, parallel, single-blind clinical study using stratified randomization of the effectiveness, tolerability and safety of the drug Povidone-iodine produced by BelAseptika JSC, in adult patients with purulent-inflammatory processes of the skin and soft tissues due to chronic venous insufficiency", phase I-II of the wound process . All patients will receive systemic traditional therapy for the underlying and concomitant diseases.	Drug: Povidon-iodine; Povidone-iodine solution 100 mg/ml produced by BelAseptika CJSC, Republic of Belarus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with trophic ulcers cured	Number of patients cured	15 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
percentage reduction in the non-epithelialized area of the wound surface in relation to the initial one	Additionally, the percentage reduction in the non-epithelialized area of the wound surface relative to the original will be calculated, determined by digital non-contact planimetry during dressing changes. This indicator will be assessed using a digital camera and image analysis software	15 days

Collaborators and Investigators

• Sponsor: Research Institute for Physical Chemical Problems of the Belarusian State University
• Collaborators: Vitebsk Regional Clinical Hospital; Unitary Enterprise UNITEHPROM BSU; The 10th Minsk City Clinical Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: January 7, 2024
• First Submitted That Met QC Criteria: January 22, 2024
• First Posted (Actual): January 30, 2024

Study Record Updates

• Last Update Posted (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 19, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: lidocaine; cellulose; diabetic foot infection; chronic venous insuffiency; miramistin
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Ulcer; Diabetic Foot; Venous Insufficiency
• Other Study ID Numbers: OLENKRON-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No