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

NCT ID: NCT02031627

Last Updated: 2021-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-11
• Study Completion Date: 2019-06-30

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.

Conditions

Lower Extremity Lymphoedema; Leg Lymphoedema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

pneumatic compression - 1 hour per day

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

Group Type: EXPERIMENTAL

pneumatic compression - 1 hour per day

Intervention Type: DEVICE

Pneumatic compression treatment once per day (1 hour)

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.

Group Type: EXPERIMENTAL

pneumatic compression - 2 hours per day

Intervention Type: DEVICE

pneumatic compression treatment twice per day in the AM \& PM (2 hours)

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)

Group Type: EXPERIMENTAL

pneumatic compression - 4 hours per day

Intervention Type: DEVICE

pneumatic compression treatment twice per day consisting of 2 consecutive 1 hour treatments in the AM \& PM (4 hours)

Interventions

pneumatic compression - 1 hour per day

Pneumatic compression treatment once per day (1 hour)

Intervention Type: DEVICE

pneumatic compression - 2 hours per day

pneumatic compression treatment twice per day in the AM \& PM (2 hours)

Intervention Type: 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)

Intervention Type: DEVICE

Other Intervention Names

Flexitouch pump; Flexitouch device; Flexitouch pump; Flexitouch device; Flexitouch pump; Flexitouch device

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tactile Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vaughan Keeley, PhD, FRCP

Role: PRINCIPAL_INVESTIGATOR

Royal Derby Hospital

Locations

Royal Derby Hospital

Derby, , United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

4010 FlexDose

Identifier Type: -

Identifier Source: org_study_id