Actively Recruiting
Detection of Small Fiber Neuropathy Using Skin Properties
Led by Brigham and Women's Hospital · Updated on 2025-02-06
400
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Small fiber neuropathy, including cardiovascular diabetic neuropathy, affects millions of people worldwide and causes disabling symptoms such as burning pain, dizziness when standing, brain fog, fatigue, constipation, urinary problems, and temperature intolerance. Early and accurate diagnosis is important for proper treatment, but current methods like skin biopsy or specialized equipment are invasive or only available at few centers. This research aims to improve diagnosis by analyzing skin pictures using mathematical image processing to detect features related to small fiber loss. The study uses specialized image processing techniques on skin photographs to extract statistical features that may indicate nerve damage associated with small fiber neuropathy. The accuracy of this diagnostic approach is verified by comparing results to skin biopsy findings. This method is being evaluated for its potential to make diagnosis more accessible and less invasive. Participants will have completed autonomic testing along with skin biopsies prior to the study. Researchers will analyze the skin images and compare them to biopsy results to measure diagnostic accuracy over a two-year period. The study is observational and involves no treatment but focuses on improving diagnostic tools. Participant involvement includes consent and undergoing skin imaging and autonomic assessments. The study is sponsored by Brigham and Women's Hospital and started in July 2021 with expected completion in February 2027.
CONDITIONS
Brief Title
Detection of Small Fiber Neuropathy Using Skin Properties
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older
- Patients who sign the informed consent form to participate in this study
- Patients who have completed autonomic testing with skin biopsies
You will not qualify if you...
- Patients with significant hair on the legs that covers the skin
- Patients with any dermatological disorder that affects skin composition
- Patients who use skin lotion on their legs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants undergo specialized image processing of skin pictures to extract features related to small fiber loss, with diagnosis verified using skin biopsies.
Periodic visits for image capture and skin biopsies as scheduled by the study team
Trial Site Locations
Total: 1 location
1
Brigham and Women's Faulkner Hospital
Boston, Massachusetts, United States, 02130
Actively Recruiting
Research Team
P
Peter Novak, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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