Treatment Response to Different Lymphoedema Compression Programs Using a Pneumatic Compression Device

Not Applicable

Completed

Conditions: Lower Extremity Lymphoedema
Leg Lymphoedema

Interventions: Device: pneumatic compression - 2 hours per day
Device: pneumatic compression - 1 hour per day
Device: pneumatic compression - 4 hours per day

Registration Number: NCT02031627

Lead Sponsor: Tactile Medical

Brief Summary: Proof of principle study in order to determine if there is a difference in treatment effect across the 3 study groups when treating lower extremity lymphoedema using a pneumatic compression device.

Detailed Description: This is a single center, 3 arm, prospective, randomized, clinical trial to assess the difference between 3 treatment options for achieving a measurable physiologic effect on lower extremity lymphedema with pneumatic compression device. Each intervention arm will include 10 completed subjects for a total of 30 completed subjects.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 21

Inclusion Criteria

Subjects must be ≥ 18 years old
Subjects must have a diagnosis of primary or secondary Stage 2 unilateral or bilateral lower extremity lymphoedema
Must currently be using adequate compression garment(s) as determined by the clinician: (Garments must be at least 20mmHg and no more than 3 months old and must be worn upon rising and removed at bedtime)
Subjects must have clinically relevant excess limb swelling as determined by clinician "pitting test"
Must be able to attend all required in-clinic treatment visits

Exclusion Criteria

Diagnosis of active or recurrent cancer, or less than 3 months at the time of initial evaluation from the completion of chemotherapy, radiation therapy, or primary surgery for the treatment of cancer
Active infection or inflammation
Active thrombophlebitis (within the last 2 months)
History of pulmonary embolism (within the last 2 months)
Documented history of deep chronic venous insufficiency or deep venous obstruction with a reflux duration of > 2 second in the deep system or any history of deep vein thrombosis (DVT)
History of pulmonary edema
History of congestive heart failure
History of chronic kidney disease with a glomerular filtration rate (GFR) of less than 30 mls per minute
Poorly controlled asthma
Symptomatic or severe peripheral artery disease (defined by current lifestyle-limiting claudication or critical limb ischemia)
Presence of an open wound or ulcer of any etiology
Diagnosis of lipoedema and lipolymphoedema
Currently using an in-home pneumatic compression device
Metal implant(s) that would interfere with bioimpedance equipment
Pacemaker or other implanted electronic device(s)
Unable or unwilling to remove bandaging from treatment regimen while participating in the study
Pregnant
Any condition where increased venous and lymphatic return is undesirable
Unable or unwilling to participate in all aspects of the study protocol and/or unable to provide informed consent
Currently participating in another clinical trial
Currently using diuretics
BMI > 40

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pneumatic compression - 2 hours per day	pneumatic compression - 2 hours per day	Pneumatic compression device - 5 consecutive days undergoing 1 hour treatment in the am and 1 hour of treatment in the pm.
pneumatic compression - 1 hour per day	pneumatic compression - 1 hour per day	Pneumatic compression device - 12 consecutive days undergoing a 1 hour treatment regimen.
pneumatic compression - 4 hours per day	pneumatic compression - 4 hours per day	Pneumatic compression device - 5 consecutive days undergoing treatment twice per day consisting of 2 consecutive 1 hour treatments in the am and the pm (4 hours total)

Primary Outcome Measures

Name	Time	Method
Limb Volume (% Change)	Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)	Limb volume changes measured via perometry reported in percent reduction. A negative value is associated with the clinically-desirable decrease in fluid.
Limb Volume (ml)	Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)	Limb volume changes measured via perometry reported in change of ml of fluid. A negative value is associated with the clinically-desirable decrease in fluid.
Change in Skin Tone	Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)	Change in skin tone (fibrosis) measured via tonometry. The tonometer is a mechanical device that gives an indication of the resistance of tissue to compression. It is used in lymphedema to give an estimate of the extent of pitting and fibrotic induration. Tonometry measures were collected at 5 anatomical locations. A negative value is associated with a clinically desirable decrease in tone.
Patient Reported Outcomes - MYMOP	Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)	Changes in patient-determined symptoms\* and change in affect the symptoms had on the subject. Measured via MYMOP (Measure Yourself Medical Outcome Profile) questionnaire. A low score indicates a good outcome. Scores range from 0 (as good as can be) to 6 (as bad as can be). \*Recorded symptoms were: Gr A, 1st symptom: none, abdominal pain and discomfort, swelling, physical, and worrying about granddaughters Gr B, 1st symptom: arthritis, hayfever, look of fat foot, right hand area of neck and shoulder, stairs, and swelling Gr C, 1st symptom: none, energy during dancing and gardening, frustration of not going out on own, swelling, mild longstanding depression, and MPT joint at base of small toe Gr A, 2nd symptom: fatigue, heaviness of leg, mental, and pain under knee Gr B, 2nd symptom: narrowed choice of footwear, shower in bath, and swollen left foot Gr C, 2nd symptom: being tired and aching all over, and shoes and clothing

Secondary Outcome Measures

Name	Time	Method
Incidence of Complications	Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)	Number of complications experienced. Incidence based on clinician assessment.
Activity Level	Day 1 compared to final treatment day (day 12 for Group A and day 5 for Groups B and C)	Change in number of steps as accumulated each day monitored through use of a pedometer. A positive number indicates an increase in step count (activity) while a negative number indicates a decrease in step count.
Cellular Fluid Changes (Ohms)	Change after initial treatment on day 1 and change baseline to end of day 5 for all groups	Changes in extra cellular fluid (ECF) on treated leg measured by bioimpedance. A negative number is indicative of a clinically desirable reduction in ECF.
Cellular Fluid Changes (% Change)	Change after initial treatment on day 1 and change baseline to end of day 5 for all groups	Changes in extra cellular fluid (ECF) on treated leg measured by bioimpedance. A negative number is indicative of a clinically desirable reduction in ECF.