Clinical trial NCT01096589: Assessment of 3M Oedema Reduction System in the Treatment of Lymphoedema Compared to Commercial Short-stretch Bandage
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphedema
Keywords: lymphoedema
lymphedema
Lead sponsor: Solventum US LLC
Sponsor class: INDUSTRY
Collaborators: name: 3M
First posted: 2010-03-31
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Percent Volume Change of Affected Limb at End of Treatment Compared to Baseline.
timeFrame: baseline and after 3 weeks of treatment
Secondary outcomes:
measure: Assessment of Safety by Incidence of Adverse Events.
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Evanston
country: United States
facility: NorthShore University Healthsystem
state: Illinois
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Houston
country: United States
facility: Memorial Hermann Hyperbaric Center
state: Texas
city: Milborne Port
country: United Kingdom
facility: 56 London Road Clinic
state: Dorset
city: Kendal
country: United Kingdom
facility: Kendal Lymphology Centre
city: Leicester
country: United Kingdom
facility: LOROS Hospice
city: Lichfield
country: United Kingdom
facility: St Giles Hospice Lymphoedema Service
city: London
country: United Kingdom
facility: Enfield Macmillan Lymphoedema Service
city: Newcastle-upon-Tyne
country: United Kingdom
facility: St Oswalds Hospice Lymphoedema Clinic
city: Swansea
country: United Kingdom
facility: Swansea Lymphoedema Service Singleton Hospital
Study officials:
affiliation: Faculty of Medicine, Division of Nursing and Healthcare, Universtity of Glasgow, G12 8LW
name: Christine Moffatt, Prof.
role: PRINCIPAL_INVESTIGATOR
References: