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

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.