- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04902651
HM242-Gel vs Comparator
July 15, 2022 updated by: B. Braun Ltd. Centre of Excellence Infection Control
A PROSPECTIVE, CONTROLLED, RANDOMIZED, OPEN-LABEL PREMARKET MULTICENTER STUDY OF THE PERFORMANCE OF THE HM242-GEL VS COMPARATOR IN PATIENTS UNDER THE CONDITION OF VENOUS LEG ULCER
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
73
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HM242-Gel
|
HM242-Gel compared to Intrasite Gel in patients with a venous leg ulcer
|
Active Comparator: Intrasite Gel
|
HM242-Gel compared to Intrasite Gel in patients with a venous leg ulcer
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: 28 days
|
The primary variable is defined as the relative reduction of the wound area of a patient in percentage 28 days (4 weeks) after baseline.
The wound size area is measured on site by the tracing method.
|
28 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 21, 2021
Primary Completion (Actual)
January 5, 2022
Study Completion (Actual)
February 16, 2022
Study Registration Dates
First Submitted
May 21, 2021
First Submitted That Met QC Criteria
May 21, 2021
First Posted (Actual)
May 26, 2021
Study Record Updates
Last Update Posted (Actual)
July 19, 2022
Last Update Submitted That Met QC Criteria
July 15, 2022
Last Verified
May 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OPM-G-H-2004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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