Clinical Research Directory

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.