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

This study is currently recruiting participants.
Verified April 2017 by Tactile Medical
Sponsor:
ClinicalTrials.gov Identifier:
NCT02031627
First Posted: January 9, 2014
Last Update Posted: April 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Tactile Medical
  Purpose
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.

Condition Intervention
Lower Extremity Lymphoedema Leg Lymphoedema Device: pneumatic compression 1 hour per day Device: pneumatic compression - 2 hours per day Device: pneumatic compression - 4 hours per day

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Physiologic Response to Varying Lymphoedema Compression Programs With the Flexitouch System

Resource links provided by NLM:


Further study details as provided by Tactile Medical:

Primary Outcome Measures:
  • Intra/extra cellular fluid changes [ Time Frame: Day 5 and 12 ]
    The study will use bioimpedance to determine intra and extra cellular fluid changes.


Estimated Enrollment: 30
Study Start Date: December 2013
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: pneumatic compression 1 hour per day
Pneumatic compression device - 12 consecutive days undergoing a 1 hour treatment regimen.
Device: pneumatic compression 1 hour per day
Pneumatic compression treatment once per day (1 hour)
Other Names:
  • Flexitouch pump
  • Flexitouch device
Experimental: 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.
Device: pneumatic compression - 2 hours per day
pneumatic compression treatment twice per day (am and pm = 2 hours)
Other Names:
  • Flexitouch pump
  • Flexitouch device
Experimental: 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)
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)
Other Names:
  • Flexitouch pump
  • Flexitouch 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must be ≥ 18 years old
  • Subjects must have a diagnosis of secondary Stage 2 unilateral or bilateral lower extremity lymphoedema.
  • Must currently be using adequate compression garment(s):
  • 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, and 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.
  • Patients with 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 implants that would interfere with bio impedance equipment
  • Individual with pacemaker or other implanted electronic devices
  • Inability or unwillingness to remove bandaging from treatment regimen while participating in the study.
  • 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
  • Currently using diuretics
  • BMI > 35
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02031627


Contacts
Contact: Sunday Hoy shoy@tactilemedical.com

Locations
United Kingdom
Royal Derby Hospital Recruiting
Derby, United Kingdom, DE22 3NE
Contact: Vaughan Keeley, PhD, FRCP         
Principal Investigator: Vaughan Keeley, PhD, FRCP         
Sponsors and Collaborators
Tactile Medical
Investigators
Principal Investigator: Vaughan Keeley, PhD, FRCP Royal Derby Hospital
  More Information

Responsible Party: Tactile Medical
ClinicalTrials.gov Identifier: NCT02031627     History of Changes
Other Study ID Numbers: 4010 FlexDose
First Submitted: January 7, 2014
First Posted: January 9, 2014
Last Update Posted: April 27, 2017
Last Verified: April 2017

Keywords provided by Tactile Medical:
lymphedema
lymphoedema
leg lymphoedema
lower extremity lymphoedema
pneumatic compression device

Additional relevant MeSH terms:
Lymphedema
Lymphatic Diseases