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

NACompletedINTERVENTIONAL
Enrollment

236

Participants

Timeline

Start Date

September 23, 2021

Primary Completion Date

March 31, 2025

Study Completion Date

March 31, 2025

Conditions
LymphedemaLymphedema of FaceLymphedema, SecondaryLymphedema Due to RadiationLymphedema; 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.

Trial Locations (10)

10310

Richmond University Medical Center, Staten Island

10467

Montefiore Medical Center, The Bronx

21205

Johns Hopkins University, Baltimore

35924

University of Alabama, Birmingham

37232

Vanderbilt University Medical Center, Nashville

40202

University of Louisville, Louisville

48109

University of Michigan, Ann Arbor

48201

Karmanos Cancer Institute, Detroit

60612

Rush University Medical Center, Chicago

76104

Advanced Head & Neck Rehabilitation Center of Texas, Fort Worth

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Vanderbilt University Medical Center

OTHER

lead

Tactile Medical

INDUSTRY

NCT04797390 - A Study Evaluating an Advanced Pneumatic Compression Device Versus Usual Care for Treatment of Head and Neck Lymphedema | Biotech Hunter | Biotech Hunter