Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
142 participants
INTERVENTIONAL
2021-05-25
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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HM242-Solution
HM242-Solution
HM242-Solution compared to Saline compared in patients with a venous leg ulcer
Saline
Saline
HM242-Solution compared to Saline compared in patients with a venous leg ulcer
Interventions
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HM242-Solution
HM242-Solution compared to Saline compared in patients with a venous leg ulcer
Saline
HM242-Solution compared to Saline compared in patients with a venous leg ulcer
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
Yes
Sponsors
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B. Braun Ltd. Centre of Excellence Infection Control
INDUSTRY
Responsible Party
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Locations
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Asl Napoli 3 Sud
Gragnano, Napoli, Italy
Dept. of Clinical and Experimental Medicine University of Pisa
Pisa, Toscany, Italy
Countries
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Central Contacts
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Facility Contacts
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Marino Ciliberti, Dr
Role: primary
Marco Romanelli, Prof
Role: primary
Other Identifiers
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OPM-G-H-2003
Identifier Type: -
Identifier Source: org_study_id