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NCT Number: NCT04759443

Detection of Small Fiber Neuropathy Using Skin Properties

Small fiber neuropathy affects millions of peoples worldwide. The neuropathy is causing disabling burning pain and dysautonomia such as dizziness with standing, brain fog, fatigue, constipation, too much or too little sweating. The detection of nerve damage is complicated and not widely available; it requires either skin biopsy or specialized equipment and training. This project utilizes the mathematical processing of skin pictures for the purpose to extract the statistical features related to loss of small fibers. This approach can improve the availability of diagnosis of small fiber neuropathy.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Brigham and Women's Faulkner Hospital

Boston, Massachusetts, 02130, United States

Location status: Recruiting

Location contact

Peter Novak, MD

CONTACT

[email protected]

About this study

Small fiber neuropathy, including cardiovascular diabetic neuropathy, affects millions of peoples worldwide. The neuropathy is causing disabling burning pain and dysautonomia such as dizziness with standing, brain fog, fatigue, constipation, urinary problems and cold or hot intolerance. Early and accurate diagnosis of neuropathy is essential for correct treatment. Available diagnostic methods are either invasive such as skin biopsy or available only in few specialized centers. This project addresses the limited availability of small fiber neuropathy detection.

The project utilizes utilize specialized image processing of skin pictures for the purpose to extract the statistical features that are related to loss of small fibers. The accuracy of the diagnosis verified using skin biopsies.

This approach can improve the availability of diagnosis of small fiber neuropathy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with age 18 year or older
  • Patients that sign the informed consent form to participate in this study
  • Patients completed the autonomic testing with skin biopsies

Exclusion criteria

  • Patients with significant hairs at the legs that will cover the skin
  • Any dermatological disorder that can affect the skin composition
  • The use of skin lotion

Treatment and study plan

Image processing of skin

Other

Image processing will be used to extract skin features that correlate with loss of small skin fibers.

Primary outcomes

  1. Diagnostic accuracy of image processing

    Time frame: 2 years

    The diagnostic accuracy of image processing will be evaluated by using the skin biopsy as a reference.

Study contacts

Contact information is provided by the study sponsor or research team.

Peter Novak, MD

CONTACT

[email protected]

617-732-7432

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Feb 18, 2021
Registry last updated
Feb 6, 2025

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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