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Skin Biophysical Measures for Assessing Head and Neck Cancer-Related External Lymphedema

Skin Biophysical Measures for Assessing Head and Neck Cancer-Related External Lymphedema

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04457375
Enrollment
70
Registered
2020-07-07
Start date
2020-01-16
Completion date
2021-01-15
Last updated
2021-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphedema, Secondary

Keywords

tissue dielectric constant, head and neck lymphedema, lymphedema, reference values

Brief summary

Selected measurements in healthy persons of skin tissue dielectric constant as reference values for subsequent use to evaluate patients with head and neck lymphedema.

Detailed description

Skin tissue dielectric constant (TDC) measurements will non-invasively be made bilaterally at two neck sites, bilaterally on two forearm sites and one site at the chin sub-mental area. Measurements are made with subjects fully clothed and seated. Measurements are made in triplicate and averaged at each site. Full measurements take about 5-7 minutest to complete. Data will be analyzed to determine the neck-to-arm ratios and chin-to-arm ratios to establish normal ranges of these parameters for subsequent use as comparisons to evaluate and track changes in patients with head and neck lymphedema.

Interventions

DIAGNOSTIC_TESTTDC

measurements

Sponsors

Nova Southeastern University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Healthy with no current or past skin conditions affecting neck or arms

Exclusion criteria

1. Known to have diabetes of any type. 2. Having facial or neck hair that prohibits accurate measurements

Design outcomes

Primary

MeasureTime frameDescription
Neck-to-Arm TDC ratioone yearNeck-to-Arm TDC ratio
Sub-Mental-to-Arm TDC ratioone yearSub-Mental-to-Arm TDC ratio

Secondary

MeasureTime frameDescription
Bilateral values and Variability in TDC valuesone yearBilateral values and Variability in TDC values

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026