Assessment of 3M Oedema Reduction System in the Treatment of Lymphoedema Compared to Commercial Short-stretch Bandage

September 30, 2024 updated by: Solventum US LLC

Preliminary Study to Assess the Effectiveness of 3M Oedema Reduction System in the Treatment of Lymphoedema Treatment Compared to Comprilan Short-stretch Bandage Compression Therapy

Objectives. The primary objective of the study is to assess volume reduction in the treatment of lymphoedematous legs and arms with compression bandaging.

Secondary objectives:

  • Assessment of safety
  • Quality of life
  • Health economic parameters
  • Slippage
  • Subbandage pressure

Study Overview

Status

Status

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

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 (Actual)

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.
82

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 Locations

  • United Kingdom
      • Kendal, United Kingdom, LA9 4BD
        • Kendal Lymphology Centre
      • Leicester, United Kingdom, LE3 9QE
        • LOROS Hospice
      • Lichfield, United Kingdom, WS14 9LH
        • St Giles Hospice Lymphoedema Service
      • London, United Kingdom, N9 7HD
        • Enfield Macmillan Lymphoedema Service
      • Newcastle-upon-Tyne, United Kingdom, NE3 1EE
        • St Oswalds Hospice Lymphoedema Clinic
      • Swansea, United Kingdom, SA2 8QA
        • Swansea Lymphoedema Service Singleton Hospital
    • Dorset
      • Milborne Port, Dorset, United Kingdom, DT9 5DW
        • 56 London Road Clinic
  • United States
    • Illinois
      • Evanston, Illinois, United States, 60201
        • Northshore University Healthsystem
    • Missouri
      • Columbia, Missouri, United States, 65203
        • University of Missouri
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
    • Texas
      • Houston, Texas, United States, 77030
        • Memorial Hermann Hyperbaric Center

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria (Arm):

  • Mobile males or females, age 18 years or older
  • Unilateral arm lymphoedema of secondary origin
  • Pitting arm lymphoedema diagnosed as stage II or late stage II according to the International Society of Lymphology staging
  • Patients who require intense bandaging therapy (approx. >= 15% increase in arm volume over the opposite healthy arm)
  • Completion of all primary and adjuvant cancer treatments (surgery, chemotherapy, radiotherapy) at least 6 months prior to randomisation
  • Willing to give written informed consent and willing to comply with the study protocol

Inclusion Criteria (Leg):

  • Mobile males or females, age 18 years or older
  • Unilateral or bilateral leg lymphoedema of primary or secondary origin
  • Pitting leg lymphoedema diagnosed as stage II or late stage II according to the International Society of Lymphology staging
  • Patients who require intense bandaging therapy
  • Completion of all primary and adjuvant cancer treatments (surgery, chemotherapy, radiotherapy) at least 6 months prior to randomisation
  • Willing to give written informed consent and willing to comply with the study protocol

Exclusion Criteria (Arm):

  • Known pregnancy
  • Evidence of active cancer, either local or metastatic
  • A period of intense daily bandaging within the last month
  • Decompensated heart failure or clinically relevant kidney or liver disease
  • Known relevant arterial disease of the arms
  • Deep vein thrombosis or phlebitis in the last 3 months
  • Paralysis of the arms
  • Clinical infection of the arms (e.g. erysipelas)
  • Wounds located at the study arm that require dressing change more than once a week
  • History of allergic reactions to study material
  • Participation in any prospective clinical study that can potentially interfere with this study
  • Participants who are, in the opinion of the clinical investigator, unsuitable for enrolment in this study, for reasons not specified in the exclusion criteria.

Exclusion Criteria (Leg):

  • Known pregnancy
  • Evidence of active cancer, either local or metastatic
  • A period of intense daily bandaging within the last month
  • Decompensated heart failure or clinically relevant kidney or liver disease
  • Deep vein thrombosis or phlebitis in the last 3 months
  • Known relevant arterial disease of the legs
  • Paralysis of the legs
  • Clinical infection of the legs (e.g. erysipelas)
  • Circumferential Lymphorrhoea
  • Wounds located at the study leg that require dressing change more than once a week
  • History of allergic reactions to study material
  • Participation in any prospective clinical study that can potentially interfere with this study
  • Participants who are, in the opinion of the clinical investigator, unsuitable for enrolment in this study, for reasons not specified in the exclusion criteria.

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

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.
Experimental: Arm 1 - 3M Coban 2
3M Coban 2 - 2 apps/wk
Device: 3M Coban 2 (Compression System)
Nonwoven cohesive backing and foam.
Experimental: Arm 2 - 3M Coban 2
3M Coban 2 - 3 apps/wk
Device: 3M Coban 2 (Compression System)
Nonwoven cohesive backing and foam.
Experimental: Arm 3 - 3M Coban 2
Arm 3 - 3M Coban 2 - 5 apps/wk
Device: 3M Coban 2 (Compression System)
Nonwoven cohesive backing and foam.
Active Comparator: Arm 4 - Comprilan
Comprilan short-stretch bandage 5 apps/wk
Device: Comprilan
Commercial short-stretch bandage (Comprilan; BSN Medical Ltd, Hull, U.K).

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
Time Frame
Percent Volume Change of Affected Limb at End of Treatment Compared to Baseline.
Time Frame: baseline and after 3 weeks of treatment
baseline and after 3 weeks of treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Assessment of Safety by Incidence of Adverse Events.
Time Frame: 3 weeks
3 weeks

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.
Solventum US LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
3M

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christine Moffatt, Prof., Faculty of Medicine, Division of Nursing and Healthcare, Universtity of Glasgow, G12 8LW

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

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.
March 1, 2010

Primary Completion (Actual)

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, 2010

Study Completion (Actual)

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.
October 1, 2010

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).
March 22, 2010

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.
March 30, 2010

First Posted (Estimated)

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.
March 31, 2010

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.
October 2, 2024

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.
September 30, 2024

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.
September 1, 2024

More Information

Terms related to this study

Keywords

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.
  • EU Study-05-000012

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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