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Recruiting NCT06418282

Clinical Study to Evaluate the Effectiveness and Health Economics of a Novel Portable Non-Pneumatic Active Compression Device (NPCD) for Lymphedema/Phlebolymphedema

No phase Interventional Phlebolymphedema Lymphedema Chronic Venous Insufficiency

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dayspring.
Who it may be relevant to
Registry conditions: Phlebolymphedema, Lymphedema, Chronic Venous Insufficiency. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

An Open-label, Multi-center, Prospective VA Study to Evaluate the Effectiveness and Health Economics of a Novel Portable Non-Pneumatic Active Compression Device (NPCD) for Lymphedema/Phlebolymphedema

Overview

An open-label, multi-center, prospective VA study to evaluate the effectiveness and health economics of a Novel Portable Non-Pneumatic Active Compression Device (NPCD) for lymphedema/phlebolymphedema

Detailed description

An open-label, multi-center, prospective VA study to evaluate the effectiveness and health economics of a Novel Portable Non-Pneumatic Active Compression Device (NPCD) for lymphedema/phlebolymphedema

Interventions

  • Device Dayspring
    NPCD

Primary outcome measures

  • Cost comparison between NPCD and historical reference (as reflected by hospital/resource utilization related to adverse events) [Time frame: 6 months]
  • Mobility (daily steps using a pedometer) [Time frame: 6 months]
  • Venous Clinical Severity Score (VCSS) [Time frame: 180 days]
Secondary outcome measures (2)
  • Lower extremity edema response (limb girth reduction) [Time frame: 6 months]
  • Safety/Adverse Events [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

  • Males and females ≥ 18 years of age
  • Capable and willing to sign the informed consent and deemed capable of following the study protocol
  • Subjects must have a diagnosis of unilateral or bilateral lower extremity edema or lower extremity lymphedema/phlebolymphedema as a consequence of chronic venous insufficiency
  • Subjects who have medical clearance using diagnostic confirmation through venous duplex to rule out DVT and superficial/deep reflux

Exclusion criteria

  • Inability or unwillingness to participate in all aspects of study protocol and/or inability to provide informed consent
  • Individuals with a history or presence of a systemic disorder or condition that could place the subject at increased risk from sequential compression therapy
  • Subjects must not have any diagnosed cognitive or physical impairment that would interfere with the use of the device
  • Non-ambulatory individuals
  • Female: BMI > 34 (5'4", 200 lbs.)
  • Male: BMI > 34 (5'9", 230 lbs.)
  • (Max circumference at patella 58 cm; Max circumference at gluteal fold 75 cm)
  • Diagnosis of lipedema
  • Diagnosis of active or recurrent cancer (< 3 months since completion of chemotherapy, radiation therapy or primary surgery for the cancer)
  • Diagnosis of acute infection (in the last four weeks)
  • Diagnosis of active/open wound/ulcer
  • Diagnosis of acute thrombophlebitis (in last 2 months)
  • Diagnosis of pulmonary embolism or deep vein thrombosis within the previous 6 months
  • Diagnosis of pulmonary edema
  • Diagnosis of congestive heart failure (uncontrolled/uncompensated)
  • Diagnosis of chronic kidney disease with acute renal failure
  • Diagnosis of epilepsy
  • Subjects with poorly controlled asthma
  • Any condition where increased venous and lymphatic return is undesirable
  • Women who are pregnant, planning a pregnancy or nursing at study entry
  • Participation in any clinical trial of an investigational substance or device during the past 30 days

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Glenn Jacobowitz — New York

Identifiers

NCT: NCT06418282 · KCT 013 (GRANDE)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗