MedTrace Logo

Two Pneumatic Compression Devices in the Treatment of Lower Extremity Lymphedema

NCT01239160 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 238

Last updated 2020-11-06

Study results available
· View outcomes & findings →

Summary

The treatment of lymphedema has been a major focus of attention for physicians and scientists for several decades. At this time, no successful techniques have been developed to prevent lymphedema, and therefore, a great deal of emphasis is placed on treatment modalities that can lessen the severity and impede the progression of this debilitating condition.

The treatment on offer usually consists of a maintenance phase using compression garments and an intensive treatment phase, which includes the use of skin care, compression bandaging, exercise and manual lymphatic drainage (MLD). The intensive phase is usually described as complex decongestive therapy (CDT). This is time consuming and requires high resource usage. Pneumatic compression devices (PCD) offer and alternative to MLD and can be used by the patient. There are a number of devices on the market that are categorized into 1. without calibrated gradient compression 2. With calibrated gradient compression.

This trial will compare two PCDs, a simple device without calibrated compression, and an advanced device with calibrated compression, in the reduction of swelling and maintenance of reduced limb volume in 262 patients with lower limb lymphoedema. The primary end point will be limb volume reduction over 12 weeks of treatment, with secondary outcome after 24 weeks.

Conditions

  • Lymphedema

Interventions

DEVICE

Flexitouch System

A segmental, programmable, gradient pneumatic compression device. It consists of a controller and garment set. The garments are constructed of nylon and have 27-32 chambers, depending upon garment size. The pressure setting is variable between "normal" and "increased." The device is intended to be used for 60 minutes per day

DEVICE

Hydroven FPR

The FH is an intermittent sequential external pneumatic compression system. The garment contains 3 compression chambers. The pressure range of the compressor device is 30-100 mmHg. It is intended to be used for 60 minutes per day.

Sponsors & Collaborators

  • Tactile Medical

    lead INDUSTRY

Principal Investigators

  • Christine J Moffatt, RN PhD · Nottingham Trent University

  • Vaughan Keeley, MD · Derby Hospitals NHS Trust

  • Margaret Sneddon, RGN · University of Glasgow

  • Peter J Franks, PhD · Tactile Medical

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-02
Primary Completion
2011-10-26
Completion
2012-06-27

Countries

  • United States
  • Australia
  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01239160 on ClinicalTrials.gov