Clinical trial NCT04116099: CVR Registry Evaluating Flexitouch Plus and Conservative Care vs Conservative Care Only for Treatment of Lymphedema
Official title: An Observational Registry Evaluating the Flexitouch® Plus in Vascular Clinic Patients With Lower Extremity Lymphedema
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Lymphedema
Keywords: Lymphedema of Leg
Chronic Venous Insufficiency
Primary Lymphedema
Secondary Lymphedema
Lead sponsor: Tactile Medical
Sponsor class: INDUSTRY
First posted: 2019-10-04
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be drawn from vascular patients with lower extremity lymphedema that is unilateral or bilateral.

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 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).

Eligibility criteria: Inclusion Criteria:

1. Male or female 18 years of age or older.
2. Diagnosis of lower extremity lymphedema (including primary, secondary, chronic venous insufficiency (CVI)-related, unilateral, or bilateral).
3. Clinical Etiology Anatomy Pathophysiology (CEAP) Classification of C3 or higher.
4. Willing to comply with prescribed care, protocol requirements, and study-related visits.
5. Willing and able to provide consent to participate.

Exclusion Criteria:

1. BMI \> 50.
2. 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).
3. Unresolved healing at the surgical site following a venous intervention (e.g., ablation, stenting, or venoplasty).
4. Heart failure (acute pulmonary edema, decompensated acute heart failure).
5. Acute venous disease (\< 6 weeks) such as acute thrombophlebitis, acute deep venous thrombosis, or acute pulmonary embolism.
6. Significant peripheral artery disease (ankle-brachial index (ABI) \< 0.6, critical limb ischemia including ischemic rest pain, arterial wounds or gangrene).
7. Active skin or limb infection/ inflammatory disease (acute cellulitis, other uncontrolled skin or untreated inflammatory skin disease).
8. Active cancer (cancer that is currently under treatment, but not yet in remission).
9. Poorly controlled kidney disease (glomerular filtration rate \< 30 mls per minute), hypoproteinemia, pulmonary hypertension, hypothyroidism, cyclic edema, or Munchausen Syndrome.
10. Any circumstance where increased lymphatic or venous return is undesirable.
11. Currently pregnant or trying to become pregnant (for Flexitouch Plus and conservative care group).
12. Current participation in any drug or other device clinical studies.

Primary outcomes:
measure: Complications
timeFrame: 12 months
measure: Number of unscheduled visits
timeFrame: 12 months
Secondary outcomes:
measure: Quality of life changes: Short-Form 12 (SF-12)
timeFrame: 6 months
measure: Quality of life changes: Quality of Life with Venous Insufficiency (CIVIQ-20)
timeFrame: 6 months
measure: Quality of life changes: Lymphedema Quality of Life Tool (LYMQOL)
timeFrame: 6 months
measure: Quality of life changes: Clinical Global Impression of Change - Global Improvement (CGI-I)
timeFrame: 6 months
measure: Quality of life changes: Patient Global Impression of Change (PGIC)
timeFrame: 6 months
measure: Edema measures
timeFrame: 6 months
measure: Presence and severity of skin changes
timeFrame: 6 months
measure: Wound area
timeFrame: 6 months
Other outcomes:
measure: Flexitouch Plus treatment satisfaction
timeFrame: 6 months
measure: Call volume
timeFrame: 12 months
Locations:
city: Glen Burnie
country: United States
facility: Center for Vein Restoration - Glen Burnie
state: Maryland
city: Greenbelt
country: United States
facility: Center for Vein Restoration - Greenbelt
state: Maryland
city: Silver Spring
country: United States
facility: Center for Vein Restoration - Silver Spring
state: Maryland
Study officials:
affiliation: Center for Vein Restoration
name: Peter Pappas
role: PRINCIPAL_INVESTIGATOR
References: