Lymphedema
Conditions
Keywords
lymphoedema, lymphedema
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
Interventions
DEVICE3M Coban 2 (Compression System)
Nonwoven cohesive backing and foam.
DEVICEComprilan
Commercial short-stretch bandage (Comprilan; BSN Medical Ltd, Hull, U.K).
Sponsors
3M
Solventum US LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Volume Change of Affected Limb at End of Treatment Compared to Baseline. | baseline and after 3 weeks of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of Safety by Incidence of Adverse Events. | 3 weeks |
Countries
United Kingdom, United States
Participant flow
Recruitment details
Participants were randomly allocated to the 4 application frequencies for 19 days. The randomisation was stratified according to limb location. Enroled participants were randomly assigned to one of the four treatment groups. Patients were treated in private lymphoedema clinics or in NHS centres (UK). US patients were treated in hospitals.
Participants by arm
| Arm | Count |
|---|---|
| Arm 1 - 3M Oedema Reduction System 3M Oedema Reduction System - 2 apps/wk
3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam. | 22 |
| Arm 2 - 3M Oedema Reduction System 3M Oedema Reduction System - 3 apps/wk
3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam. | 20 |
| Arm 3 - 3M Oedema Reduction System 3M Oedema Reduction System - 5 apps/wk
3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam. | 22 |
| Arm 4 - Commercial Compression System 5 Apps/wk Commercial Compression System 5 apps/wk
Short-stretch Bandage (Comprilan; BSN Medical Ltd,). : Commercial short-stretch bandage (Comprilan; BSN Medical Ltd, Hull, U.K). | 18 |
| Total | 82 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 | 2 | 1 |
| Overall Study | Compliance with protocol | 0 | 0 | 1 | 0 |
| Overall Study | found treatment exhausting | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 1 | 1 | 1 |
Baseline characteristics
| Characteristic | Arm 1 - 3M Oedema Reduction System | Arm 2 - 3M Oedema Reduction System | Arm 3 - 3M Oedema Reduction System | Arm 4 - Commercial Compression System 5 Apps/wk | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 11 Participants | 11 Participants | 4 Participants | 33 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 9 Participants | 11 Participants | 14 Participants | 49 Participants |
| Age, Continuous | 59.73 years STANDARD_DEVIATION 13.29 | 61.85 years STANDARD_DEVIATION 14.49 | 62.27 years STANDARD_DEVIATION 13.25 | 56.22 years STANDARD_DEVIATION 14.78 | 60.16 years STANDARD_DEVIATION 13.85 |
| Region of Enrollment United Kingdom | 17 participants | 17 participants | 20 participants | 16 participants | 70 participants |
| Region of Enrollment United States | 5 participants | 3 participants | 2 participants | 2 participants | 12 participants |
| Sex: Female, Male Female | 20 Participants | 20 Participants | 20 Participants | 17 Participants | 77 Participants |
| Sex: Female, Male Male | 2 Participants | 0 Participants | 2 Participants | 1 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 13 / 22 | 11 / 20 | 14 / 22 | 10 / 18 |
| serious Total, serious adverse events | 0 / 22 | 0 / 20 | 0 / 22 | 0 / 18 |
Outcome results
Primary
Percent Volume Change of Affected Limb at End of Treatment Compared to Baseline.
Time frame: baseline and after 3 weeks of treatment
Population: Patients must have completed the first week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 - 3M Oedema Reduction System | Percent Volume Change of Affected Limb at End of Treatment Compared to Baseline. | -14.56 % volume change measured in mL. | Standard Deviation 12.22 |
| Arm 2 - 3M Oedema Reduction System | Percent Volume Change of Affected Limb at End of Treatment Compared to Baseline. | -7.09 % volume change measured in mL. | Standard Deviation 7.3 |
| Arm 3 - 3M Oedema Reduction System | Percent Volume Change of Affected Limb at End of Treatment Compared to Baseline. | -10.24 % volume change measured in mL. | Standard Deviation 8.65 |
| Arm 4 - Commercial Compression System 5 Apps/wk | Percent Volume Change of Affected Limb at End of Treatment Compared to Baseline. | -9.84 % volume change measured in mL. | Standard Deviation 4.34 |
Secondary
Assessment of Safety by Incidence of Adverse Events.
Time frame: 3 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1 - 3M Oedema Reduction System | Assessment of Safety by Incidence of Adverse Events. | 13 No. of treatment-emergent adverse events |
| Arm 2 - 3M Oedema Reduction System | Assessment of Safety by Incidence of Adverse Events. | 11 No. of treatment-emergent adverse events |
| Arm 3 - 3M Oedema Reduction System | Assessment of Safety by Incidence of Adverse Events. | 14 No. of treatment-emergent adverse events |
| Arm 4 - Commercial Compression System 5 Apps/wk | Assessment of Safety by Incidence of Adverse Events. | 10 No. of treatment-emergent adverse events |