HM242-Solution vs Comparator

November 19, 2021 updated by: B. Braun Ltd. Centre of Excellence Infection Control

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
142

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Italy
    • Napoli
      • Gragnano, Napoli, Italy, 80054
        • Recruiting
        • Asl Napoli 3 Sud
        • Contact:
    • Toscany
      • Pisa, Toscany, Italy, 56126
        • Recruiting
        • Dept. of Clinical and Experimental Medicine University of Pisa
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Saline
Device: Saline
HM242-Solution compared to Saline compared in patients with a venous leg ulcer
Experimental: HM242-Solution
Device: HM242-Solution
HM242-Solution compared to Saline compared in patients with a venous leg ulcer

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
B. Braun Ltd. Centre of Excellence Infection Control

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 25, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 21, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 26, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 22, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OPM-G-H-2003

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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