Assessment of 3M Oedema Reduction System in the Treatment of Lymphoedema Compared to Commercial Short-stretch Bandage
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
1 other identifier
interventional
82
2 countries
11
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2010
Shorter than P25 for not_applicable
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 22, 2010
CompletedFirst Posted
Study publicly available on registry
March 31, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedResults Posted
Study results publicly available
November 27, 2012
CompletedOctober 2, 2024
September 1, 2024
7 months
March 22, 2010
July 20, 2012
September 30, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent Volume Change of Affected Limb at End of Treatment Compared to Baseline.
baseline and after 3 weeks of treatment
Secondary Outcomes (1)
Assessment of Safety by Incidence of Adverse Events.
3 weeks
Study Arms (4)
Arm 1 - 3M Coban 2
EXPERIMENTAL3M Coban 2 - 2 apps/wk
Arm 2 - 3M Coban 2
EXPERIMENTAL3M Coban 2 - 3 apps/wk
Arm 3 - 3M Coban 2
EXPERIMENTALArm 3 - 3M Coban 2 - 5 apps/wk
Arm 4 - Comprilan
ACTIVE COMPARATORComprilan short-stretch bandage 5 apps/wk
Interventions
Commercial short-stretch bandage (Comprilan; BSN Medical Ltd, Hull, U.K).
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
- 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
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Solventum US LLClead
- 3Mcollaborator
Study Sites (11)
NorthShore University Healthsystem
Evanston, Illinois, 60201, United States
University of Missouri
Columbia, Missouri, 65203, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Memorial Hermann Hyperbaric Center
Houston, Texas, 77030, United States
56 London Road Clinic
Milborne Port, Dorset, DT9 5DW, United Kingdom
Kendal Lymphology Centre
Kendal, LA9 4BD, United Kingdom
LOROS Hospice
Leicester, LE3 9QE, United Kingdom
St Giles Hospice Lymphoedema Service
Lichfield, WS14 9LH, United Kingdom
Enfield Macmillan Lymphoedema Service
London, N9 7HD, United Kingdom
St Oswalds Hospice Lymphoedema Clinic
Newcastle upon Tyne, NE3 1EE, United Kingdom
Swansea Lymphoedema Service Singleton Hospital
Swansea, SA2 8QA, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Prof. Christine Moffatt, Principal Investigator
- Organization
- Centre for Reasearch and Implementation of Clinical Practice (CRICP)
Study Officials
- PRINCIPAL INVESTIGATOR
Christine Moffatt, Prof.
Faculty of Medicine, Division of Nursing and Healthcare, Universtity of Glasgow, G12 8LW
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2010
First Posted
March 31, 2010
Study Start
March 1, 2010
Primary Completion
October 1, 2010
Study Completion
October 1, 2010
Last Updated
October 2, 2024
Results First Posted
November 27, 2012
Record last verified: 2024-09