Status:
TERMINATED
CVR Registry Evaluating Flexitouch Plus and Conservative Care vs Conservative Care Only for Treatment of Lymphedema
Lead Sponsor:
Tactile Medical
Conditions:
Lymphedema
Eligibility:
All Genders
18+ years
Brief 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.
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 10 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 24 2021
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT04116099
Start Date
October 10 2019
End Date
November 24 2021
Last Update
March 31 2022
Active Locations (3)
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1
Center for Vein Restoration - Glen Burnie
Glen Burnie, Maryland, United States, 21061
2
Center for Vein Restoration - Greenbelt
Greenbelt, Maryland, United States, 20770
3
Center for Vein Restoration - Silver Spring
Silver Spring, Maryland, United States, 20903