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

This is an interventional treatment trial for Lymphedema focused on measuring lymphoedema, lymphedema Read More

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.