Clinical Research Directory

Major Inclusion Criteria: * Written informed consent for participation in the study * Male or female patient aged ≥18 years * BMI ≥18.5 and ≥40.0 kg/m2 * Lower leg wound due to venous insufficiency * Target wound has failed to heal despite standard wound care for a minimum of 6 weeks * A surface area of the target wound of ≥2 and ≤40 cm2 Major Exclusion Criteria: * Signs or symptoms of clinically significant ongoing infection i the target wound requiring anti-microbial treatment * History of autoimmune disease, such as but not limited to systemic lupus erythematosus, Addison's disease, Crohn's disease and type I diabetes mellitus * B-HbA1C value ≥52 mmol/mol * Plaque psoriasis or any other skin disease that could interfere with the outcome of the study * Arterial insufficiency * History of any malignancy within the past 5 years * Target wound diagnosed as a malignant wound, neuropathic wound, pressure wound or osteomyelitis * Patients who are immunocompromised due to disease or for other reasons such as the use of systemic immunosuppressants