Clinical trial NCT02031627: Treatment Response to Different Lymphoedema Compression Programs Using a Pneumatic Compression Device
Official title: Physiologic Response to Varying Lymphoedema Compression Programs With the Flexitouch System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Extremity Lymphoedema
Leg Lymphoedema
Keywords: lymphedema
lymphoedema
leg lymphoedema
lower extremity lymphoedema
pneumatic compression device
Lead sponsor: Tactile Medical
Sponsor class: INDUSTRY
First posted: 2014-01-09
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Limb Volume (ml)
timeFrame: Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
measure: Limb Volume (% Change)
timeFrame: Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
measure: Change in Skin Tone
timeFrame: Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
measure: Patient Reported Outcomes - MYMOP
timeFrame: Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
Secondary outcomes:
measure: Cellular Fluid Changes (Ohms)
timeFrame: Change after initial treatment on day 1 and change baseline to end of day 5 for all groups
measure: Cellular Fluid Changes (% Change)
timeFrame: Change after initial treatment on day 1 and change baseline to end of day 5 for all groups
measure: Incidence of Complications
timeFrame: Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
measure: Activity Level
timeFrame: Day 1 compared to final treatment day (day 12 for Group A and day 5 for Groups B and C)
Other outcomes:
measure: Change in Skin Thickness
timeFrame: Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
measure: Change in Local Tissue Water (LTW)
timeFrame: Change baseline to final day (day 12 for Group A and day 5 for Groups B and C)
Locations:
city: Derby
country: United Kingdom
facility: Royal Derby Hospital
Study officials:
affiliation: Royal Derby Hospital
name: Vaughan Keeley, PhD, FRCP
role: PRINCIPAL_INVESTIGATOR
References: