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 theinformed consent form.

Exclusion Criteria:

• known contraindication for application of hydrogel dressings, incl. Berovenal® andNU-GEL Hydrogel with Alginate;

• at the time of randomisation - documented reduction in Index ulcer area by > 20%, ascompared 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 affectedfoot within 3 months prior to Visit 1;

• use of wound dressings that include growth factors, bioengineered tissues, or skinsubstitutes within 14 days prior to Visit 1, or documented intention to use themduring the subject's participation;

• use of any investigational drug(s) or device(s), systemic immunosuppressivetreatment (including systemic corticosteroids), or application of topical steroidsto 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 diseasethat could pose an additional risk for the participant, or could significantlyinfluence interpretation of the results (as evaluated by the investigator);

• known history of non-compliance and/or presence of any condition(s) seriouslycompromising the subject's ability to adhere to the procedures required by thisClinical Investigational Plan;

• pregnant or breast-feeding females;

• females of childbearing potential not using an effective method of contraception.