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

NCT06232421 | Not Yet Recruiting Phase 2

• 1 other identifier: OLENKRON-01
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Diabetic Foot Infections; Chronic Venous Insufficiency

Keywords

diabetic foot infection; chronic venous insuffiency; lidocaine; cellulose; miramistin

Outcome Measures

Primary Outcomes (1)

• Number of patients with trophic ulcers cured

  Number of patients cured

  15 days

Secondary Outcomes (1)

• percentage reduction in the non-epithelialized area of the wound surface in relation to the initial one

  15 days

Study Arms (4)

Patients with the neuropathic form. Treatment with Foscelantan

EXPERIMENTAL

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

Patients with the neuropathic form. Treatment with Povidone-iodine

ACTIVE COMPARATOR

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

Patients with chronic venous insufficiency. Treatment with Foscelantan

EXPERIMENTAL

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

Patients with chronic venous insufficiency. Treatment with Povidone-iodine

ACTIVE COMPARATOR

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

Interventions

Foscelantan DRUG

"Foscelantan, medicinal plate 4.0x5.0 cm in package No. 1" produced by UNITEHPROM BSU, Republic of Belarus

Patients with chronic venous insufficiency. Treatment with Foscelantan; Patients with the neuropathic form. Treatment with Foscelantan

Povidon-iodine DRUG

Povidone-iodine solution 100 mg/ml produced by BelAseptika CJSC, Republic of Belarus

Patients with chronic venous insufficiency. Treatment with Povidone-iodine; Patients with the neuropathic form. Treatment with Povidone-iodine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (2)

10th CITY CLINICAL HOSPITAL

Minsk, Minsk City, 220096, Belarus

Location

Health care institution Vitebsk Regional Clinical Hospital

Vitebsk, Vitebsk Oblast, 210037, Belarus

Location

Central Study Contacts

Eugen Grinyuk, Ph.D., Associate professor

CONTACT

+375 17 209-52-54; hryniuk@bsu.by

Pavel Bychkovsky, Ph.D., Associate Professor

CONTACT

+375 17 209-58-40; bychkovsky@tut.by

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2024
• First Posted: January 30, 2024
• Study Start: November 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)