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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Pneumatic compression treatment once per day (1 hour)
pneumatic compression treatment twice per day in the AM \& PM (2 hours)
pneumatic compression treatment twice per day consisting of 2 consecutive 1 hour treatments in the AM \& PM (4 hours)
Royal Derby Hospital
Derby, United Kingdom
Limb Volume (ml)
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.
Time frame: Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
Limb Volume (% Change)
Limb volume changes measured via perometry reported in percent reduction. A negative value is associated with the clinically-desirable decrease in fluid.
Time frame: Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
Change in Skin Tone
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.
Time frame: Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
Patient Reported Outcomes - MYMOP
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
Time frame: Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
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Cellular Fluid Changes (Ohms)
Changes in extra cellular fluid (ECF) on treated leg measured by bioimpedance. A negative number is indicative of a clinically desirable reduction in ECF.
Time frame: Change after initial treatment on day 1 and change baseline to end of day 5 for all groups
Cellular Fluid Changes (% Change)
Changes in extra cellular fluid (ECF) on treated leg measured by bioimpedance. A negative number is indicative of a clinically desirable reduction in ECF.
Time frame: Change after initial treatment on day 1 and change baseline to end of day 5 for all groups
Incidence of Complications
Number of complications experienced. Incidence based on clinician assessment.
Time frame: Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
Activity Level
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.
Time frame: Day 1 compared to final treatment day (day 12 for Group A and day 5 for Groups B and C)