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Completed

NCT Number: NCT04457375

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

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

Completed

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Key information

Conditions

Lymphedema, Secondary Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nova Southeastern University

Fort Lauderdale, Florida, 33328, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

TDC

Diagnostic Test

measurements

Primary outcomes

  1. Neck-to-Arm TDC ratio

    Time frame: one year

    Neck-to-Arm TDC ratio

  2. Sub-Mental-to-Arm TDC ratio

    Time frame: one year

    Sub-Mental-to-Arm TDC ratio

Secondary outcomes

  1. Bilateral values and Variability in TDC values

    Time frame: one year

    Bilateral values and Variability in TDC values

Sponsors and collaborators

Lead sponsor

Nova Southeastern University

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 7, 2020
Registry last updated
Jun 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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