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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

63 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-10

Study Completion Date

2021-11-24

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Lymphedema

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Conservative care

Intervention Type OTHER

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.

Conservative care

Intervention Type OTHER

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

Flexitouch Plus

Intervention Type DEVICE

Flexitouch Plus treatment.

Interventions

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Conservative care

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

Intervention Type OTHER

Flexitouch Plus

Flexitouch Plus treatment.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No