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

Physiologic Response to Varying Lymphoedema Compression Programs With the Flexitouch System

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.

Study Overview

• Status: Completed
• Conditions: Lower Extremity Lymphoedema; Leg Lymphoedema
• Intervention / Treatment: Device: pneumatic compression - 1 hour per day; Device: pneumatic compression - 2 hours per day; Device: pneumatic compression - 4 hours per day

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.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Derby, United Kingdom, DE22 3NE
    • Royal Derby Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: pneumatic compression - 1 hour per day; Pneumatic compression device - 12 consecutive days undergoing a 1 hour treatment regimen.	Device: pneumatic compression - 1 hour per day; Pneumatic compression treatment once per day (1 hour); Other Names: Flexitouch pump; Flexitouch device
Experimental: 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.	Device: pneumatic compression - 2 hours per day; pneumatic compression treatment twice per day in the AM & PM (2 hours); Other Names: Flexitouch pump; Flexitouch device
Experimental: 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)	Device: pneumatic compression - 4 hours per day; pneumatic compression treatment twice per day consisting of 2 consecutive 1 hour treatments in the AM & PM (4 hours); Other Names: Flexitouch pump; Flexitouch device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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	Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Day 1 compared to final treatment day (day 12 for Group A and day 5 for Groups B and C)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Skin Thickness	Change in skin thickness measured by ultrasound. Ultrasound measures were collected at 5 anatomical locations. A negative value is associated with a clinically desirable reduction in skin thickness (a surrogate measure of oedema).	Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
Change in Local Tissue Water (LTW)	Change in local tissue water (LTW) within the skin measured by MoistureMeterD (MMD). MMD measures were collected at 5 anatomical locations using 2 probes: medium (M25) and large (L50). A negative value is associated with a clinically desirable decrease in LTW (a surrogate measure of oedema).	Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)

Collaborators and Investigators

• Sponsor: Tactile Medical
• Investigators: Principal Investigator: Vaughan Keeley, PhD, FRCP, Royal Derby Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2013
• Primary Completion (Actual): March 31, 2019
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: January 7, 2014
• First Submitted That Met QC Criteria: January 7, 2014
• First Posted (Estimate): January 9, 2014

Study Record Updates

• Last Update Posted (Actual): July 20, 2021
• Last Update Submitted That Met QC Criteria: June 29, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: lymphedema; lymphoedema; leg lymphoedema; lower extremity lymphoedema; pneumatic compression device
• Additional Relevant MeSH Terms: Lymphatic Diseases; Lymphedema
• Other Study ID Numbers: 4010 FlexDose