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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04759443
Other study ID # 2021P000410
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 1, 2021
Est. completion date February 1, 2025

Study information

Verified date February 2024
Source Brigham and Women's Hospital
Contact Peter Novak, MD
Phone 617-732-7432
Email pnovak2@bwh.harvard.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 400
Est. completion date February 1, 2025
Est. primary completion date February 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Brigham and Women's Faulkner Hospital Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Diagnostic accuracy of image processing The diagnostic accuracy of image processing will be evaluated by using the skin biopsy as a reference. 2 years
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