Trial record 4 of 147 for:    "Lymphedema"

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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014