HM242-Solution vs Comparator

B. Braun

Status

Unknown

Conditions

Venous Leg Ulcer

Treatments

Device: Saline

Device: HM242-Solution

Study type

Interventional

Funder types

Industry

Identifiers

NCT04902612

OPM-G-H-2003

Details and patient eligibility

About

The objectives of this study include investigating the performance of HM242-Solution compared to normal Saline with respect to venous leg ulcer healing. Saline is widely used for venous leg ulcer cleansing and has served as comparator or standard treatment in clinical trials evaluating new cleansing products to prove that it is as good as the standard treatment. Data will also be collected on the patients' quality of life and any adverse events that may arise during the study.

Enrollment

142 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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