Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06232421
Other study ID # OLENKRON-01
Secondary ID
Status Not yet recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date June 2024
Est. completion date December 2024

Study information

Verified date April 2024
Source Research Institute for Physical Chemical Problems of the Belarusian State University
Contact Eugen Grinyuk, Ph.D., Associate professor
Phone +375 17 209-52-54
Email hryniuk@bsu.by
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 224
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design


Intervention

Drug:
Foscelantan
"Foscelantan, medicinal plate 4.0x5.0 cm in package No. 1" produced by UNITEHPROM BSU, Republic of Belarus
Povidon-iodine
Povidone-iodine solution 100 mg/ml produced by BelAseptika CJSC, Republic of Belarus

Locations

Country Name City State
Belarus 10th CITY CLINICAL HOSPITAL Minsk
Belarus Health care institution Vitebsk Regional Clinical Hospital Vitebsk

Sponsors (4)

Lead Sponsor Collaborator
Research Institute for Physical Chemical Problems of the Belarusian State University The 10th Minsk City Clinical Hospital, Unitary Enterprise UNITEHPROM BSU, Vitebsk Regional Clinical Hospital

Country where clinical trial is conducted

Belarus, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients with trophic ulcers cured Number of patients cured 15 days
Secondary 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
See also
  Status Clinical Trial Phase
Terminated NCT02462096 - A Feasibility Study of the ReLeaf Catheter System N/A
Enrolling by invitation NCT05504070 - Venclose digiRF System Post Market Study N/A
Completed NCT05507346 - A Clinical Study to Evaluate the Effectiveness of a Novel Portable Non-Pneumatic Active Compression Device vs. an Advanced Pneumatic Compression Device for Treating Lower Extremity Lymphedema N/A
Recruiting NCT05622500 - Best Endovenous Treatment, Including STenting, Versus Non-endovenous Treatment in Chronic Proximal Deep Venous Disease N/A
Completed NCT03283800 - Copper Impact on Venous Insufficiency and Lipodermatosclerosis N/A
Terminated NCT02248740 - Radiofrequency Ablation vs. Laser Ablation of the Incompetent Small Saphenous Vein Phase 4
Completed NCT01501188 - Efficacy Study of Kinesio Taping to Treat Muscular and Joint Problems in Chronic Venous Insufficiency Phase 1
Completed NCT02236338 - Radiofrequency Ablation vs Laser Ablation of the Incompetent Greater Saphenous Vein Phase 4
Recruiting NCT05982405 - Long-term Effects of Inspiratory Muscle Training in Chronic Venous Insufficiency N/A
Completed NCT05383469 - Efficacy of Active Versus Passive Methods in Chronic Venous Insufficiency N/A
Completed NCT06238791 - Plantar Pressure Analysis and Foot Biomechanics in Lipedema and Chronic Venous Disease
Withdrawn NCT02559427 - SPA Therapy in the Treatment of Sleep Apnea Syndrome N/A
Completed NCT02346058 - Efficacy and Safety of Esarin Gel in Chronic Venous Insufficiency and Varicose Veins Phase 4
Active, not recruiting NCT05926830 - Extracorporeal Flow Abolition in Relation With Primary Insufficiency of Great Saphenous Veins (GSV) Using High Intensity Focused Ultrasound (HIFU) Generated by Sonovein: A Multi Center Prospective Pivotal Study N/A
Withdrawn NCT05047302 - Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System-Canada N/A
Active, not recruiting NCT04339075 - Registry to Investigate the Efficacy and Safety of VenaBlock VeIn SEaling System for VaRicose Veins in SingApore
Active, not recruiting NCT04580160 - Venous Stent for the Iliofemoral Vein Investigational Clinical Trial Using the DUO Venous Stent System N/A
Not yet recruiting NCT02927483 - Study to Assess the Efficacy and Safety of Endolex Forte VErsus Diosmin and Hesperidin in Reducing VeNous Insufficiency Phase 3
Completed NCT02015221 - Evaluation of a Dual Action Pneumatic Compression Device: Patient Ease of Use and Comfort N/A
Completed NCT02050061 - Chronic Venous Insufficiency; Impact of Compression Stockings on Quality of Life N/A