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

Tactile Medical

Status: Completed

Conditions: Leg Lymphoedema; Lower Extremity Lymphoedema

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02031627

4010 FlexDose

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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21 participants in 3 patient groups

pneumatic compression - 1 hour per day

Experimental group

Description:

Pneumatic compression device - 12 consecutive days undergoing a 1 hour treatment regimen.

Treatment:

Device: pneumatic compression - 1 hour per day

pneumatic compression - 2 hours per day

Experimental group

Description:

Pneumatic compression device - 5 consecutive days undergoing 1 hour treatment in the am and 1 hour of treatment in the pm.

Treatment:

Device: pneumatic compression - 2 hours per day

pneumatic compression - 4 hours per day

Experimental group

Description:

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)

Treatment:

Device: pneumatic compression - 4 hours per day