NIPH Clinical Trials Search

The investigation of adherence to self-management using an pneumatic lymphatic drainage for lower limb secondary lymphoedema: A pilot study

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Secondary lower limb lymphedema
Date of first enrollment	2025/12/01
Target sample size	30
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	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 use in clinical settings. The following device will be used: Name: Sequential Air-Pressure Lymph Flow Promotion Device (PLD) Limiti (Technokatsura Co., Ltd.) Medical Device Approval Number: 30600BZX00129000 (Attached documentation will be submitted separately as an appendix) The PLD implementation protocol will be conducted as outlined below. Frequency: Once daily Duration: 30 minutes Intensity and compression direction: Optimal intensity determined by the physician prior to intervention Period: 2 weeks (outpatient visits must be scheduled within the range from 2 weeks after the start of intervention to 4 weeks after, with treatment continued until the day before the outpatient visit)

Outcome(s)

Primary Outcome

Adherence of a home Pneumatic lymphatic drainage

Secondary Outcome

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)

Key inclusion & exclusion criteria

Age minimum	35years-old
Age maximum	80years-old
Gender	Male and Female
Include criteria
Exclude 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