Secondary lower limb lymphedema
Conditions
Interventions
This study will have participants implement self-management at home using a combination therapy that includes the use of PLD. PLD is a medical device that has been approved in Japan and is already in
Sponsors
Keio University
Kita Fukushima Medical Center Kosei hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Outpatient with secondary lower limb lymphedema 2) Experience worsening of their lymphedema in the past 3 months 3) Age: 35 and 80 years 4) Consent to participate in this study 5) ISL stage II or III
Exclusion criteria
Exclusion criteria: 1) DVT, thrombophlebitis, PE, or suspected these conditions 2) Ssevere arteriosclerosis or ischemic disease in the treated area 3) CHF 4) Possible negative effect by increasing blood flow to the heart 5) Weak bones (osteoporosis, etc.), a fracture or dislocation in the treated area 6) Acute inflammatory findings (dermatitis, cellulitis, etc.), severe skin disorders, ulcers, necrosis or gangrene in the treated area 7) Weak or unstable skin in the treated area, or recent skin graft 8) Sensory disorders in the treated area 9) Acute or chronic abdominal diseases, or Recent abdominal surgery 10) Muscle strain, torn fascia or muscle fibres, sprains or tendonitis in the treated area 11) Pregnancy 12) Patients who the doctor deems unsuitable for PLD use, such as those who cannot use it properly 13) Dementia, intellectual disability or suspected these conditions 14) Communicational difficulties with medical staff and maintenance staff due to language problems, etc. 15) Patients who have difficulty working with doctors during past medical treatment 16) Incapability of attending regular check-ups according to doctor requirement 17) Inpatients 18) Participation in a other clinical trial in the past 4 months 19) Severe peripheral neuropathy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adherence of a home Pneumatic lymphatic drainage | — |
Secondary
| Measure | Time frame |
|---|---|
| Demographic information (age, gender, height, weight, BMI, dominant hand) Social background (employment status, household members) Medical information (primary disease, side of lymphedema, symptoms associated with lymphedema, medical history , drug history, ISL stage, peripheral circulatory status) Safety and tolerability (tolerability-limiting events, adverse events, deviations, usability) Efficacy (lower limb circumference, QOL: J-LYMQOL-l, subjective assessment) Other (physical activity : GPAQ, adherence of compression and weight management) | — |
Countries
Japan
Contacts
Public ContactHiroki Okawara
Keio University Department of Rehabilitation Medicine, School of Medicine
Outcome results
None listed