Prospective randomised controlled trial comparing volume reduction with medical adaptive compression systems (MAC) and short-stretch bandages in complete decongestive therapy (phase I) of lymphoedema
Not Applicable
Recruiting
- Conditions
- Bilateral lymphoedema of the lower limb, stage 2 to 3
- Registration Number
- DRKS00030816
- Lead Sponsor
- Charité - Universitätsmedizin Berlin, Arbeitsbereich Physikalische Medizin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 25
Inclusion Criteria
informed consent, indication for CPD phase I, bilateral symmetrical lymphoedema (+/- 170 ml side difference), oedema stage II-III, fundamental physical ability for self-management of compression therapy, sufficient language comprehension and mental health for study participation, willingness to participate in the study.
Exclusion Criteria
Skin folds indicating additional padding, exceeding the maximum measurements for the application of MAC systems, expected incompliance (assessment), existing absolute or relative contraindications to CDT, contraindications to parts of the CDT, expected study drop-out,
unclear aetiology of the oedema
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method volume (optoelectronic measurement)
- Secondary Outcome Measures
Name Time Method Compression pressure, pressure distribution (via PicoPress®), manageability (VAS) Required time (min., sec.), wearing comfort (VAS)