Overview

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

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.