Trial record 4 of 140 for:    "Lymphedema"

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

This study is currently recruiting participants.
Verified January 2014 by Tactile Medical
Sponsor:
Information provided by (Responsible Party):
Tactile Medical
ClinicalTrials.gov Identifier:
NCT02031627
First received: January 7, 2014
Last updated: January 17, 2014
Last verified: January 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]
    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: August 2014
Estimated Primary Completion Date: August 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Tactile Medical
ClinicalTrials.gov Identifier: NCT02031627     History of Changes
Other Study ID Numbers: 4010 FlexDose
Study First Received: January 7, 2014
Last Updated: January 17, 2014
Health Authority: United Kingdom: National Health Service
United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Lymphedema
Lymphatic Diseases

ClinicalTrials.gov processed this record on April 17, 2014