CVR Registry Evaluating Flexitouch Plus and Conservative Care vs Conservative Care Only for Treatment of Lymphedema

  • STATUS
    Recruiting
  • End date
    Apr 17, 2022
  • participants needed
    300
  • sponsor
    Tactile Medical
Updated on 17 February 2020
Investigator
Susy Peters
Primary Contact
Center for Vein Restoration - Greenbelt (4.3 mi away) Contact
+2 other location
lower extremity lymphedema

Summary

Subjects with lower extremity lymphedema will be prescribed, per standard of care, to either Flexitouch Plus with conservative care or conservative care only and be followed for 12 months.

Description

Conservative care treatment for lymphedema may include use of compression, manual lymphatic drainage (MLD, performed either by a therapist or self-MLD), exercises and skin care. Subjects presenting to a vein clinic (Center for Vein Restoration or CVR) with lymphedema of the lower extremity/ies may receive a standard-of-care prescription for conservative care or for the Flexitouch Plus pneumatic compression device along with conservative care. Subjects will be followed (by phone and in clinic) for 12 months after initiating treatment for venous- and lymphedema-related complications, unscheduled visits, changes in quality of life measures and edema measures, skin changes, and changes to wounds (if present).

Details
Treatment conservative care, Flexitouch Plus
Clinical Study IdentifierNCT04116099
SponsorTactile Medical
Last Modified on17 February 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Lymphedema?
Male or female 18 years of age or older
Diagnosis of lower extremity lymphedema (including primary, secondary, chronic venous insufficiency (CVI)-related, unilateral, or bilateral)
Clinical Etiology Anatomy Pathophysiology (CEAP) Classification of C3 or higher
Willing to comply with prescribed care, protocol requirements, and study-related visits
Willing and able to provide consent to participate

Exclusion Criteria

BMI > 50\
Significant venous reflux disease, as determined by the investigator (e.g., indicated for venous intervention, post intervention with inadequate venous function, or ultrasound evidence of deep venous obstruction)
Unresolved healing at the surgical site following a venous intervention (e.g., ablation, stenting, or venoplasty)
Heart failure (acute pulmonary edema, decompensated acute heart failure)
Acute venous disease (< 6 weeks) such as acute thrombophlebitis, acute deep venous thrombosis, or acute pulmonary embolism
Significant peripheral artery disease (ankle-brachial index (ABI) < 0.6, critical limb ischemia including ischemic rest pain, arterial wounds or gangrene)
Active skin or limb infection/ inflammatory disease (acute cellulitis, other uncontrolled skin or untreated inflammatory skin disease)
Active cancer (cancer that is currently under treatment, but not yet in remission)
Poorly controlled kidney disease (glomerular filtration rate < 30 mls per minute), hypoproteinemia, pulmonary hypertension, hypothyroidism, cyclic edema, or Munchausen Syndrome
Any circumstance where increased lymphatic or venous return is undesirable
Currently pregnant or trying to become pregnant (for Flexitouch Plus and conservative care group)
Current participation in any drug or other device clinical studies
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