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A Study Evaluating an Advanced Pneumatic Compression Device Versus Usual Care for Treatment of Head and Neck Lymphedema

NCT04797390 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 236

Last updated 2026-03-02

Study results available
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Summary

To compare the effectiveness of an APCD to Usual Care in the management of lymphedema and fibrosis (LEF) in head and neck cancer (HNC) survivors.

Conditions

  • Lymphedema
  • Lymphedema of Face
  • Lymphedema, Secondary
  • Lymphedema Due to Radiation
  • Lymphedema; Surgical

Interventions

DEVICE

Advanced Pneumatic Compression Device (APCD)

Once daily treatment with Flexitouch Plus.

OTHER

Usual Care

Usual care consists of a two-phase CDT. Phase 1 includes consultation with a lymphedema therapist, patient education, MLD, compression garments or bandages, skin care techniques, and a program of exercises and postural recommendations. Phase 2 consists of ongoing self-care, where patients conduct a life-long program of disease management that mimics the program in phase 1.

Sponsors & Collaborators

  • Vanderbilt University Medical Center

    collaborator OTHER

  • Tactile Medical

    lead INDUSTRY

Principal Investigators

  • Barbara Murphy, MD · Vanderbilt University Medical Center

  • Sheila Ridner, RN, PhD · Vanderbilt University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-23
Primary Completion
2024-12-03
Completion
2024-12-03
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04797390 on ClinicalTrials.gov