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

An Observational Registry Evaluating the Flexitouch® Plus in Vascular Clinic Patients With Lower Extremity Lymphedema

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.

Study Overview

• Status: Terminated
• Conditions: Lymphedema
• Intervention / Treatment: Other: Conservative care; Device: Flexitouch Plus

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).

• Study Type: Observational
• Enrollment (Actual): 63

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Glen Burnie, Maryland, United States, 21061
      • Center for Vein Restoration - Glen Burnie
    • Greenbelt, Maryland, United States, 20770
      • Center for Vein Restoration - Greenbelt
    • Silver Spring, Maryland, United States, 20903
      • Center for Vein Restoration - Silver Spring

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; May include graduated compression, MLD performed by a licensed therapist, self-MLD, and instruction on exercise and skin 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; May include graduated compression, MLD performed by a licensed therapist, self-MLD, and instruction on exercise and skin care.; Device: Flexitouch Plus; Flexitouch Plus treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life changes: Short-Form 12 (SF-12)	To evaluate the effectiveness of the Flexitouch Plus and conservative care, compared to conservative care alone, in vascular patients with lower extremity lymphedema after 6 months of treatment based upon changes in the SF-12. This survey includes 12 questions to measure physical and mental health from the patient's point of view. The questionnaire includes eight health domains: physical functioning, physical health problems, bodily pain, general health, vitality, social functioning, emotional health problems, and mental health. The scoring mechanism uses T scores for all surveys using means and standard deviations from the 1998 US general population. A higher score represents better function.	6 months
Quality of life changes: Quality of Life with Venous Insufficiency (CIVIQ-20)	To evaluate the effectiveness of the Flexitouch Plus and conservative care, compared to conservative care alone, in vascular patients with lower extremity lymphedema after 6 months of treatment based upon changes in the CIVIQ-20, which is a survey specific to assess patient-perceived quality of life with chronic venous disorders. The instrument reviews four dimensions - psychological (range 9-45), pain (range 4-20), physical (range 4-20), and social (range 3-15). A global index score can be obtained by adding up the scores of all 20 items (range 20-100). A low score corresponds to greater patient comfort.	6 months
Quality of life changes: Lymphedema Quality of Life Tool (LYMQOL)	To evaluate the effectiveness of the Flexitouch Plus and conservative care, compared to conservative care alone, in vascular patients with lower extremity lymphedema after 6 months of treatment based upon changes in the LYMQOL, used to assess lymphedema symptom changes. LYMQOL includes sub-scores for function (range 8-32), appearance (range 7-28), symptoms (range 5-20), and mood (range 6-24) where lower scores represent a better outcome. It also includes an overall QOL sub-score (range 0-10) where a higher score represents a better outcome.	6 months
Quality of life changes: Clinical Global Impression of Change - Global Improvement (CGI-I)	To evaluate the effectiveness of the Flexitouch Plus and conservative care, compared to conservative care alone, in vascular patients with lower extremity lymphedema after 6 months of treatment based upon a clinician's response to one question at the 6 month follow-up visit pertaining to overall clinical improvement (range 1-7). A lower score signifies greater improvement.	6 months
Quality of life changes: Patient Global Impression of Change (PGIC)	To evaluate the effectiveness of the Flexitouch Plus and conservative care, compared to conservative care alone, in vascular patients with lower extremity lymphedema after 6 months of treatment based upon the patient's response to one question at the 6 month follow-up visit pertaining to overall status change (range 1-7). A lower score signifies greater improvement.	6 months
Edema measures	To evaluate the effectiveness of the Flexitouch Plus and conservative care, compared to conservative care alone, in vascular patients with lower extremity lymphedema after 6 months of treatment based upon changes in edema measures on affected/ most affected leg.	6 months
Presence and severity of skin changes	To evaluate the effectiveness of the Flexitouch Plus and conservative care, compared to conservative care alone, in vascular patients with lower extremity lymphedema after 6 months of treatment based upon skin changes on affected/ most affected leg.	6 months
Wound area	To evaluate the effectiveness of the Flexitouch Plus and conservative care, compared to conservative care alone, in vascular patients with lower extremity lymphedema after 6 months of treatment based upon percent wound area reduction in subjects presenting with wounds.	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Flexitouch Plus treatment satisfaction	To evaluate Flexitouch Plus treatment satisfaction after 6 months of treatment.	6 months
Call volume	Assess subject call volume for conservative care subjects compared to subjects using the Flexitouch Plus and conservative care.	12 months

Collaborators and Investigators

• Sponsor: Tactile Medical
• Investigators: Principal Investigator: Peter Pappas, Center for Vein Restoration

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2019
• Primary Completion (Actual): November 24, 2021
• Study Completion (Actual): November 24, 2021

Study Registration Dates

• First Submitted: September 11, 2019
• First Submitted That Met QC Criteria: October 3, 2019
• First Posted (Actual): October 4, 2019

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 30, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Chronic Venous Insufficiency; Lymphedema of Leg; Primary Lymphedema; Secondary Lymphedema
• Additional Relevant MeSH Terms: Lymphatic Diseases; Lymphedema
• Other Study ID Numbers: 5020 (South African Clinical Trials Registry)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes