Status:
TERMINATED
HM242-Gel vs Comparator
Lead Sponsor:
B. Braun Ltd. Centre of Excellence Infection Control
Conditions:
Venous Leg Ulcer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The primary objective of the study is to demonstrate that the HM242-Gel performs at least comparably to INTRASITE Gel with regard to wound healing.
Eligibility Criteria
Inclusion
- Males or females of at least 18 years at the time of enrolment
- The legal capacity and ability 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
- 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
- In the case of heavily exuding ulcers, if in the opinion of Investigator the patient is not suitable for treatment with gel
- 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, immunosuppressant, 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
Key Trial Info
Start Date :
May 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 16 2022
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT04902651
Start Date
May 21 2021
End Date
February 16 2022
Last Update
July 19 2022
Active Locations (3)
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1
Kožní ambulance Fialová, s.r.o.
Prague, Praha 6, Czechia, 16000
2
Viliam Cibik
Pruské, Slovakia, 018 52
3
Rudolf Suchy
Trenčín, Slovakia, 911 01