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

NCT04116099 | Terminated DMC FDA Device

• 1 other identifier: 5020
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 3

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.

Conditions

Lymphedema

Keywords

Lymphedema of Leg; Chronic Venous Insufficiency; Primary Lymphedema; Secondary Lymphedema

Outcome Measures

Primary Outcomes (2)

• Complications

  To evaluate the Flexitouch Plus and conservative care, compared to conservative care alone, in vascular patients with lower extremity lymphedema after 12 months of treatment based upon the number of lymphedema and venous-related complications.

  12 months

• Number of unscheduled visits

  To evaluate the Flexitouch Plus and conservative care, compared to conservative care alone, in vascular patients with lower extremity lymphedema after 12 months of treatment based upon the number of lymphedema and venous-related unscheduled follow-up visits (non-routine clinic, hospital, urgent care, and emergency room visits).

  12 months

Secondary Outcomes (8)

• Quality of life changes: Short-Form 12 (SF-12)

  6 months

• Quality of life changes: Quality of Life with Venous Insufficiency (CIVIQ-20)

  6 months

• Quality of life changes: Lymphedema Quality of Life Tool (LYMQOL)

  6 months

• Quality of life changes: Clinical Global Impression of Change - Global Improvement (CGI-I)

  6 months

• Quality of life changes: Patient Global Impression of Change (PGIC)

  6 months

Other Outcomes (2)

• Flexitouch Plus treatment satisfaction

  6 months

• Call volume

  12 months

Study Arms (2)

Conservative care alone

Conservative care alone which may include graduated compression, manual lymphatic drainage (MLD) performed by a licensed therapist, self-MLD, and instruction on exercise and skin care.

Other: Conservative care

Flexitouch Plus and conservative care

Flexitouch Plus and conservative care which includes Flexitouch Plus treatment as well as conservative care measures which may include graduated compression, manual lymphatic drainage (MLD) performed by a licensed therapist, self-MLD, and instruction on exercise and skin care.

Other: Conservative care; Device: Flexitouch Plus

Interventions

Conservative care OTHER

May include graduated compression, MLD performed by a licensed therapist, self-MLD, and instruction on exercise and skin care.

Conservative care alone; Flexitouch Plus and conservative care

Flexitouch Plus DEVICE

Flexitouch Plus treatment.

Flexitouch Plus and conservative care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tactile Medical: lead

Study Sites (3)

Center for Vein Restoration - Glen Burnie

Glen Burnie, Maryland, 21061, United States

Location

Center for Vein Restoration - Greenbelt

Greenbelt, Maryland, 20770, United States

Location

Center for Vein Restoration - Silver Spring

Silver Spring, Maryland, 20903, United States

Location

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Peter Pappas

  Center for Vein Restoration

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2019
• First Posted: October 4, 2019
• Study Start: October 10, 2019
• Primary Completion: November 24, 2021
• Study Completion: November 24, 2021
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)