Clinical trial · Interventional
Therapeutical Assessment of Compression Armsleeves for Lymphatic Indications
Therapeutical Assessment of Compression Armsleeves for Lymphatic Indications (Therapeutische Bewertung Von Armkompressionsstrümpfen für Lymphatische Indikationen BF09-PH-01)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphedema | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Compression Armsleeves | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Compression ArmsleevesType A
- description
- Product A: armsleeves of type SoraLife KKl. 2 according to RAL GZ 387
- interventionNames
- Other: Compression Armsleeves
- type
- ACTIVE_COMPARATOR
- label
- Compression Armsleeves Type B
- description
- Product B: armsleeves of type Elvarex KKl. 2 according to RAL GZ 387
- interventionNames
- Other: Compression Armsleeves
Primary outcomes (1)
- measure
- change of volume (arm and hand together)
- timeFrame
- 6 weaks per patient
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available