Lymphedema Clinical Trial
— BF09-PH-01Official title:
Therapeutical Assessment of Compression Armsleeves for Lymphatic Indications (Therapeutische Bewertung Von Armkompressionsstrümpfen für Lymphatische Indikationen BF09-PH-01)
Examination of therapeutical effects of different types of armsleeves in treating lymphatic
diseases after breast cancer surgery during maintenance phase
1. thesis:
- all types should be equal regarding volume reduction
2. thesis: armsleeves manufactured with microfibre yarn are expected to be
- better in wearing comfort and
- better in handling features.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | November 2011 |
Est. primary completion date | October 2011 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - women with a secondary arm-lymphedema for at least 3 months - willingness to wear compression arm-sleeves for at least 12 hours per day - maintenance phase, where no significant further reduction of arm-volume can be achieved - lymphedema in stadium 1 or 2 - age: at least 18 years - signed consent form by the patient - sufficient knowledge in national language Exclusion Criteria: - edema not completely reduced to "maintenance phase" - immobilized patient - acute deep vein thrombosis in arm - directly after arm-vein-thrombosis - acute arm erysipelas - malignant edema - existent lipedema - arterial occlusion - distinctive neuropathy in upper limbs - neurinoma in upper limbs - chronic pain after plastic surgery in upper limbs, shoulder or breast - change in drug treatment, that can influence edema situation during the study - pregnant women - breast giving mothers - not signed consent form - participation in a second clinical trial |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Austria | Landeskrankenhaus Wolfsberg | Wolfsberg | Kärnten |
Belgium | Universitaire Ziekenhuizen | Leuven | |
Germany | Klinik und Poliklinik für Hautkrankheiten, Sauerbruchstraße | Greifswald | Mecklenburg Vorpommern |
Netherlands | Nij Smellinghe Hosptial | Drachten |
Lead Sponsor | Collaborator |
---|---|
University Medicine Greifswald | Landeskrankenhaus Wolfsberg, Nij Smellinghe Hosptial, Universitaire Ziekenhuizen Leuven |
Austria, Belgium, Germany, Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change of volume (arm and hand together) | During a 2-weeks-phase the volume of patients arm and hand together is measured once a week, e.g. 3 times (beginning, after 1 week, at the end). This is done with armsleeves of the first type. After one week of sedation the test will be repeated with the second product. Randomization is given by chance, that during first phase product of type A or type B can be applied. During second phase then vice versa. The measurements were performed by an "inverse water plethysmography device" (later: inverse watervolumetry) desinged by R. Damstra. |
6 weaks per patient | No |
Secondary | Clinical judgement of skin status | clinical judgement of skin status with photo documentation, clinical finding (as palpation,check on fibrosclerosis, skin clour, skin surface, edema, tenderness, tissue consistency...), check of skin contamination | 6 weaks per patient | No |
Secondary | Wearing comfort and handling features of armsleeves | For both types of products questionaires are prepared to find out how patients are feeling with their armsleeves.It is asked for problems during donning procedure as well as during wearing period. This will be done in the beginning after 1 week and after 2 weeks for both types. At the end the study nurses are asked to their impression regarding patients acceptance of the armsleeves. Method: VAS score |
6 weeks per patient | No |
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