Venous Leg UlcerNCT04902612
HM242-Solution vs Comparator
A study testing HM242-Solution and Saline in people with Venous Leg Ulcer, run by B. Braun Ltd. Centre of Excellence Infection Control at 2 sites in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Venous Leg Ulcer
- What is being tested?
- HM242-Solution and Saline
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 2 sitesItaly
- Study dates
- 25 May 2021to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
Asl Napoli 3 Sud
Gragnano, Napoli, 80054
Marino Ciliberti, Dr, (+39) 0815367613, marinodoct@gmail.com
- Recruiting
Dept. of Clinical and Experimental Medicine University of Pisa
Pisa, Toscany, 56126
Marco Romanelli, Prof, +39 050 992436, m.romanelli@med.unipi.it
About this study
Official title: Prospective, Controlled, Randomized, Double-blind, Premarket Multi-centre Study on the Performance of HM242-Solution vs Comparator in Patients Under Condition of Venous Leg Ulcer
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.
- Conditions
- Venous Leg Ulcer
- Being tested
- HM242-Solution, Saline
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HM242-SolutionDevice
HM242-Solution compared to Saline compared in patients with a venous leg ulcer
SalineDevice
HM242-Solution compared to Saline compared in patients with a venous leg ulcer
| Study group | Role | What they receive |
|---|---|---|
| HM242-Solution | Experimental | Not described Receives: Device: HM242-Solution |
| Saline | Active comparator | Not described Receives: Device: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of the study is to demonstrate that the HM242-Solution performs at least comparably to Saline regarding wound healing.
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.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start25 May 2021
- Primary completionOct 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Leg UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- B. Braun Ltd. Centre of Excellence Infection Control
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04902612
- Sponsor's protocol ID
- OPM-G-H-2003
- Status last verified
- Nov 2021
- First submitted
- 21 May 2021
- Last updated
- 22 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Controlled, Randomized, Double-blind, Premarket Multi-centre Study on the Performance of HM242-Solution vs Comparator in Patients Under Condition of Venous Leg Ulcer
- ClinicalTrials.gov ID
- NCT04902612
- Acronym / sponsor ID
- OPM-G-H-2003
- Conditions
- Venous Leg Ulcer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- B. Braun Ltd. Centre of Excellence Infection ControlIndustry (pharma, biotech, devices)
- Study start
- 25 May 2021 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 26 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HM242-Solution | Experimental | Device: HM242-Solution |
| Saline | Active comparator | Device: Saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HM242-SolutionHM242-Solution compared to Saline compared in patients with a venous leg ulcer | Device | HM242-Solution |
| SalineHM242-Solution compared to Saline compared in patients with a venous leg ulcer | Device | Saline |
Primary outcome
The primary objective of the study is to demonstrate that the HM242-Solution performs at least comparably to Saline regarding 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HM242-Solution and Saline in people with Venous Leg Ulcer, run by B. Braun Ltd. Centre of Excellence Infection Control at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joerg Brechbuehl (+41 58 258 50 00, joerg.brechbuehl@bbraun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary objective of the study is to demonstrate that the HM242-Solution performs at least comparably to Saline regarding wound healing. (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2021.