The Purpose of This Study is to Assess Clinical Efficacy and Safety of Berovenal® Intended to Promote Treatment and to Expedite Chronic Diabetic Foot Ulcer Healing

Официальное название

A Prospective, 8-week, Multi-centre, Randomised, Open-label Clinical Investigation Comparing Clinical Efficacy and Safety of Berovenal® with a Reference Amorphous Hydrogel in Subjects with Shallow, Non-infected, Chronic Diabetic Foot Ulcer

Обзор

The goal of this clinical investigation is to evaluate clinical efficacy of medical device Berovenal® intended to promote treatment and to expedite healing of chronic diabetic foot ulcer in male or female subjects aged 18-85 years with diabetes mellitus (type 1 or 2) and with present diabetic foot ulcer by providing moist environment similar to intracellular environment of the damaged tissue. It will also learn about the safety of medical device Berovenal®. The main questions it aims to answer are: * Does medical device Berovenal® lower the size of diabetic foot ulcer? * What medical problems do participants have when using medical device Berovenal®? Researchers will compare medical device Berovenal® to a reference device (device with similar purpose of use). Participants will: * Use medical device Berovenal® or a reference device every day for 8 weeks or to the time point when the diabetic foot is closed * Visit the clinic once every 2 weeks for checkups and tests * Keep a diary of their symptoms and the number of times they use medical device Berovenal® or a reference device

Вмешательства

• Устройство Berovenal®
  Easy to spread, water-washable, light brown, turbid hydrogel in tube containing 30 g of hydrogel and closed with a plastic screw cap.
• Устройство NU-GEL Hydrogel with Alginate
  Transparent, easy to spread and water-washable hydrogel in ampoule (concertina pack) containing 25 g or 15 g of hydrogel and closed with a plastic cap.

Первичные конечные точки

• Evaluation of clinical efficacy based on comparison of the percentage reduction in Index ulcer area. [Срок оценки: 8 weeks]

Вторичные конечные точки (8)

• Evaluation of clinical efficacy based on proportion of subjects who achieved complete closure of Index ulcers [Срок оценки: 8 weeks]
• Evaluation of clinical efficacy based on median time until complete Index ulcer closure [Срок оценки: 8 weeks]
• Evaluation of clinical efficacy based on proportion of subjects who achieved a reduction in the Index ulcer area by ≥ 80% [Срок оценки: 4, 6 and 8 weeks]
• Evaluation of clinical efficacy based on mean percentage change of the Index ulcer area [Срок оценки: 2, 4, 6 and 8 weeks]
• Evaluation of clinical efficacy based on improvement in the subject's reported quality of life assessed by the Wound-QoL [Срок оценки: 2, 4, 6 and 8 weeks]
• Evaluation of safety based on proportion of target wounds with a documented wound infection [Срок оценки: 8 weeks]
• Evaluation of safety occurrence of adverse events, device failures or complaints [Срок оценки: 8 weeks]
• Evaluation of clinical efficacy based on wound healing process [Срок оценки: 2, 4, 6 and 8 weeks]

Критерии участия

Критерии включения

• male, or female subjects aged 18-85 years;
• diabetes mellitus (type 1 or 2) documented at least 12 months prior to Visit 1;
• presence of a diabetic foot ulcer meeting the following criteria (Index ulcer):

• grade 1 or 2 according to the Wagner classification;
• if applicable, surgically debrided ≥ 7 days prior to Visit 1;
• at the time of randomisation:
• sized 1 - 25 cm2;
• present for ≥ 14 days;
• offloaded for ≥ 7 days;
• not infected.
• HbA1c ≤ 10% (DCCT) or 85.8 mmol/mol (IFCC) at Visit 1;
• willing and able to comply with the scheduled procedures;
• legally capable, able to understand the provided information and willing to sign the informed consent form.

Критерии исключения

• known contraindication for application of hydrogel dressings, incl. Berovenal® and NU-GEL Hydrogel with Alginate;
• at the time of randomisation - documented reduction in Index ulcer area by > 20%, as compared to its size at Visit 1;
• Index ulcer primarily caused by a medical condition other than diabetes mellitus;
• inadequate arterial circulation to the foot documented within 28 days prior to Visit 1, or during the screening period:

• Ankle-brachial Index < 0.7 or > 1.3 and/or
• Toe-brachial Index < 0.7;
• presence of acute Charcot's neuro-arthropathy, or osteomyelitis, on the affected foot within 3 months prior to Visit 1;
• use of wound dressings that include growth factors, bioengineered tissues, or skin substitutes within 14 days prior to Visit 1, or documented intention to use them during the subject's participation;
• use of any investigational drug(s) or device(s), systemic immunosuppressive treatment (including systemic corticosteroids), or application of topical steroids to the Index ulcer surface, within 28 days prior to Visit 1;
• use of cytotoxic chemotherapy and/or radiotherapy within 6 months prior to Visit 1;
• known history of bone cancer or metastatic disease of the affected limb;
• poor nutritional status;
• presence of an on-going uncontrolled renal, hepatic, cardiovascular or other disease that could pose an additional risk for the participant, or could significantly influence interpretation of the results (as evaluated by the investigator);
• known history of non-compliance and/or presence of any condition(s) seriously compromising the subject's ability to adhere to the procedures required by this Clinical Investigational Plan;
• pregnant or breast-feeding females;
• females of childbearing potential not using an effective method of contraception.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Польша · 7 центров

• Diab Serwis Popenda Spółka Jawna — Chorzów
• Uniwersyteckie Centrum Kliniczne — Gdansk
• Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET — Krakow
• MIKOMED Sp. z o.o. — Lodz
• Wojewódzka Poradnia Diabetologiczna, Gabinet Stopy Cukrzycowej — Olsztyn
• Centrum Medyczne Omedica Jarosław Opiela I Beata Opiela Spółka Jawna — Poznan
• Ginemedica Sp. z o.o. Sp. k. — Wroclaw

Германия · 2 центра

• Klinik Kösching — Kösching
• Universitätsklinikum Heidelberg — Heidelberg

Идентификаторы

NCT: NCT06584617 · BER202001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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