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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
3M
ClinicalTrials.gov Identifier:
NCT01096589
First received: March 22, 2010
Last updated: November 26, 2012
Last verified: November 2012
  Purpose

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

Condition Intervention
Lymphedema
Device: 3M Coban 2 (Compression System)
Device: Comprilan

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by 3M:

Primary Outcome Measures:
  • Percent Volume Change of Affected Limb at End of Treatment Compared to Baseline. [ Time Frame: baseline and after 3 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessment of Safety by Incidence of Adverse Events. [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 82
Study Start Date: March 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01096589

Locations
United States, Illinois
NorthShore University Healthsystem
Evanston, Illinois, United States, 60201
United States, Missouri
University of Missouri
Columbia, Missouri, United States, 65203
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Memorial Hermann Hyperbaric Center
Houston, Texas, United States, 77030
United Kingdom
56 London Road Clinic
Milborne Port, Dorset, United Kingdom, DT9 5DW
Kendal Lymphology Centre
Kendal, United Kingdom, LA9 4BD
LOROS Hospice
Leicester, United Kingdom, LE3 9QE
St Giles Hospice Lymphoedema Service
Lichfield, United Kingdom, WS14 9LH
Enfield Macmillan Lymphoedema Service
London, United Kingdom, N9 7HD
St Oswalds Hospice Lymphoedema Clinic
Newcastle-upon-Tyne, United Kingdom, NE3 1EE
Swansea Lymphoedema Service Singleton Hospital
Swansea, United Kingdom, SA2 8QA
Sponsors and Collaborators
3M
Investigators
Principal Investigator: Christine Moffatt, Prof. Faculty of Medicine, Division of Nursing and Healthcare, Universtity of Glasgow, G12 8LW
  More Information

No publications provided

Responsible Party: 3M
ClinicalTrials.gov Identifier: NCT01096589     History of Changes
Other Study ID Numbers: EU Study-05-000012
Study First Received: March 22, 2010
Results First Received: July 20, 2012
Last Updated: November 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by 3M:
lymphoedema
lymphedema

Additional relevant MeSH terms:
Lymphedema
Lymphatic Diseases
Monensin
Anti-Infective Agents
Antifungal Agents
Antiparasitic Agents
Antiprotozoal Agents
Coccidiostats
Enzyme Inhibitors
Ionophores
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Proton Ionophores
Sodium Ionophores
Therapeutic Uses
Uncoupling Agents

ClinicalTrials.gov processed this record on October 22, 2014