Two Pneumatic Compression Devices in the Treatment of Lower Extremity Lymphedema

NCT01239160 | Terminated Results DMC

• 1 other identifier: Flexitouch 1010
• Study Type: interventional
• Target: 238
• Locations: 3 countries
• Sites: 22

Brief 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

Keywords

lymphedema; pneumatic compression device; randomised clinical trial; volume reduction

Outcome Measures

Primary Outcomes (2)

• Limb Volume Change Between Baseline and 12 Weeks of Treatment - ml

  Limb volume in ml as assessed using the tape measure method of collecting circumferential leg measurements to insert into the truncated cone formula for limb volume calculation. A positive score indicates volume reduction between baseline and the noted follow-up, while a negative score indicates volume increase.

  Baseline to 12 weeks was the primary outcome; other time points included for informational purposes.

• Limb Volume Change Baseline to 12 Weeks of Treatment - Percent

  Limb volume (percent change from baseline) as assessed using the tape measure method of collecting circumferential leg measurements to insert into the truncated cone formula for limb volume calculation. A positive score indicates volume reduction between baseline and the noted follow-up, while a negative score indicates volume increase.

  Baseline to 12 weeks was the primary outcome; other time points included for informational purposes.

Secondary Outcomes (1)

• Adverse Events - Totals

  Up to 24 weeks of treatment

Study Arms (2)

Advanced PCD

EXPERIMENTAL

The use of an advanced PCD device to reduce and maintain limb volume

Device: Flexitouch System

Simple PCD

ACTIVE COMPARATOR

The use of the Simple PCD is to reduce and maintain limb volume

Device: Hydroven FPR

Interventions

Flexitouch System DEVICE

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

Advanced PCD

Hydroven FPR DEVICE

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.

Simple PCD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must be ≥ 18 years old or legal age in host country.
• Subjects must have a diagnosis of primary or secondary late Stage 2 or 3 unilateral or bilateral lower extremity lymphoedema.
• At time of initial evaluation, individuals must be at least 3 months post-surgery, chemotherapy and/or radiation treatment for cancer if applicable.
• If subjects were treated in a clinic setting for lymphoedema (Phase 1 treatment) they must be at least 3 months post completion of their acute care.

You may not qualify if:

• 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.
• Diagnosis of acute infection. The source of the infection must be treated for 2 weeks prior to admittance into the study.
• Diagnosis of acute thrombophlebitis (in last 2 months)
• Diagnosis of peripheral arterial disease (PAD): PAD is defined as an Ankle Brachial Index (ABI), of 0.7 or lower.
• Diagnosis of pulmonary embolism or deep vein thrombosis within the previous 6 months
• Diagnosis of pulmonary edema
• Diagnosis of congestive heart failure (uncontrolled)
• Diagnosis of chronic kidney disease with a Glomerular Filtration Rate (GFR) of less than 30 mls per minute.
• Patients with poorly controlled asthma (i.e. those with severe persistent symptoms throughout the day, night time awakenings several times per week, use of a beta2 agonist inhaler several times per day and those whose normal activity is extremely limited).
• Pregnancy
• Any condition where increased venous and lymphatic return is undesirable
• Inability or unwillingness to participate in all aspects of study protocol and/or inability to provide informed consent
• Currently participating in another clinical trial

Sponsors & Collaborators

• Tactile Medical: lead

Study Sites (22)

Hope Research Institute

Phoenix, Arizona, 85050, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Prairie Education & Research Cooperative

Springfield, Illinois, 62701, United States

Location

University of Missouri-Columbia,Ellis Fischel Cancer Center, Lymphedema Therapy Clinic

Columbia, Missouri, 65203, United States

Location

Stony Brook University Medical Center

Stony Brook, New York, 11794-8191, United States

Location

Carolinas Rehabilitation

Charlotte, North Carolina, 28203, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Greenville Hospital Systems

Greenville, South Carolina, 29615, United States

Location

Fletcher Allen Health Care, Inc., University of Vermont

Colchester, Vermont, 05446, United States

Location

Flinders Medical Center

Adelaide, Australia

Location

LOROS Hospice

Leicester, Leics, LE3 9QE, United Kingdom

Location

King's Mill Hospital

Mansfield, Nottinghamshire, United Kingdom

Location

University of Glasgow

Glasgow, Scotland, G12 8LL, United Kingdom

Location

Abertawe Bro Morgannwg University

Swansea, West Glamorgan, United Kingdom

Location

Royal Derby Hospital

Derby, DE22 3NE, United Kingdom

Location

St Oswalds Hospice

Gosforth, NE25 8SU, United Kingdom

Location

Kendal Lymphology Centre

Kendal, LA9 4BD, United Kingdom

Location

Norfolk and Norwich University

Norwich, United Kingdom

Location

Queens Medical Center

Nottingham, United Kingdom

Location

Lymphoedema Clinic, Singleton Hospital

Swansea, SA2 8QA, United Kingdom

Location

St Giles Hospice

Whittington, WS14 9LH, United Kingdom

Location

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Limitations and Caveats

Early termination DSMB recommendation on 23Jan2012 due to underpowered endpoint in 26Oct2011 dataset. Results presented include 130 subjects who had completed the 12 week follow up (or who withdrew within 12 weeks) prior to the 26Oct2011 dataset.

Results Point of Contact

• Title: Director of Clinical Research
• Organization: Tactile Medical

astone@tactilemedical.com

612-540-5267

Study Officials

• Christine J Moffatt, RN PhD

  Nottingham Trent University

  STUDY CHAIR

• Vaughan Keeley, MD

  Derby Hospitals NHS Trust

  STUDY DIRECTOR

• Margaret Sneddon, RGN

  University of Glasgow

  PRINCIPAL INVESTIGATOR

• Peter J Franks, PhD

  Tactile Medical

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2010
• First Posted: November 11, 2010
• Study Start: November 2, 2010
• Primary Completion: October 26, 2011
• Study Completion: June 27, 2012
• Last Updated: November 6, 2020
• Results First Posted: October 14, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (11); US (10); AU (1)