HM242-Solution vs Comparator

This is an interventional treatment trial for Venous Leg Ulcer Read More

Inclusion Criteria:

• Males or females of at least 18 years at the time of enrolment
• Has the legal capacity and is able to understand the nature, risks, significance and scope of the clinical trial and to determine his or her will accordingly
• Signed form of consent, including the understanding of and willingness by the patient to participate in the clinical study and ability to comply with study procedures and study visit schedule
• Patients must be willing to have all dressing changes performed by the wound specialist, with no treatments at home
• Presence of at least one venous ulcer of the lower leg extending through the full thickness of the skin but not down to muscle, tendon or bone
• Size of study ulcer ≥ 2cm² and ≤ 100cm² measured using the tracing method
• Presence of venous leg ulcer for at least 6 weeks, but not longer than 12 months
• Ankle Brachial Pressure Index (ABI) > 0.75
• In the case of a female patient of childbearing potential, willingness to use highly effective methods of contraception (failure rate of < 1% when used consistently and correctly); acceptable contraceptive measures in this trial are: combined pill and progestin-only pill, contraceptive patch, ring or injection, Etonogestrel implant, intrauterine device (IUD) (copper and Levonogestrel), male sterilization (vasectomy), female sterilization (abdominal, laparoscopic, hysteroscopic), or sexual abstinence.

Exclusion Criteria:

• Patients kept in an institution due to an official or court order
• Patients dependent on the Sponsor, Investigator or Site
• Patients suspected of having SARS-CoV-2 infection or COVID-19 disease
• Study ulcer judged by the Investigator to be caused by a medical condition other than venous insufficiency
• Study ulcer with signs and symptoms of infection, or under suspicion of cancer
• Study ulcer under treatment with topical antimicrobials within past two weeks or systemic antimicrobial treatment within past two weeks
• More than two venous leg ulcers or more than two chronic wounds
• Dementia stage greater than 3 according to Reisberg
• Known allergies against wound dressings used in the study
• Known chronical skin diseases, dermatoses, or known allergies or other conditions which might trigger dermatitis
• Acute cases of substance use disorders (ICD-10 F1x.1 or F1x.2)
• Buerger's disease
• Participation in Medical Device trials less than 4 weeks ago or participation in Drug trials less than six months ago
• Terminally ill patients
• Patients with poorly managed diabetes mellitus: absence of a glycated hemoglobin test within the last 3 months or a result of HbA1c ≥ 8% not older than 3 months, or a major diabetes-related incident within the past 4 weeks
• Ulcers of diabetic origin
• Patients under treatment with systemic corticosteroids, immunosuppressants, cytotoxic chemotherapy, or radiotherapy
• Presence of one or more medical conditions (other than venous insufficiency and diabetes) as determined by medical history, which:
• Is known to interfere with the wound healing process (e.g. arteriopathy, vasculitis, rheumatoid arthritis, systemic lupus erythematosus, other auto-immune diseases, cancer, immunodeficiency, severe lymphedema of the leg, thrombophilia)
• In the opinion of the Investigator, would make the patient an inappropriate candidate for this venous ulcer healing study (e.g. malnutrition, hygiene, obesity)
• Pregnant or lactating patients