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

Not Applicable

Completed

• Conditions: Lymphedema
• Interventions: Device: 3M Coban 2 (Compression System); Device: Comprilan

• Registration Number: NCT01096589
• Lead Sponsor: Solventum US LLC

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-22
• Study First Submitted QC: 2010-03-30
• Study First Posted: 2010-03-31
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Results First Submitted: 2012-07-20
• Results First Submitted QC: 2012-11-26
• Results First Posted: 2012-11-27
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1 - 3M Coban 2	3M Coban 2 (Compression System)	3M Coban 2 - 2 apps/wk
Arm 2 - 3M Coban 2	3M Coban 2 (Compression System)	3M Coban 2 - 3 apps/wk
Arm 3 - 3M Coban 2	3M Coban 2 (Compression System)	Arm 3 - 3M Coban 2 - 5 apps/wk
Arm 4 - Comprilan	Comprilan	Comprilan short-stretch bandage 5 apps/wk

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Assessment of Safety by Incidence of Adverse Events.	3 weeks

Trial Locations

Locations (11)

NorthShore University Healthsystem; 🇺🇸 Evanston, Illinois, United States

University of Missouri; 🇺🇸 Columbia, Missouri, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Memorial Hermann Hyperbaric Center; 🇺🇸 Houston, Texas, United States

56 London Road Clinic; 🇬🇧 Milborne Port, Dorset, United Kingdom

Kendal Lymphology Centre; 🇬🇧 Kendal, United Kingdom

LOROS Hospice; 🇬🇧 Leicester, United Kingdom

St Giles Hospice Lymphoedema Service; 🇬🇧 Lichfield, United Kingdom

Enfield Macmillan Lymphoedema Service; 🇬🇧 London, United Kingdom

St Oswalds Hospice Lymphoedema Clinic; 🇬🇧 Newcastle-upon-Tyne, United Kingdom

Swansea Lymphoedema Service Singleton Hospital; 🇬🇧 Swansea, United Kingdom