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Diagnostic Accuracy of The Water Immersion Wrinkle Test for Small Fiber Neuropathy

NCT07255573 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 38

Last updated 2025-12-08

No results posted yet for this study

Summary

Small-fiber neuropathy (SFN) affects A-delta and C fibers and commonly presents with sensory symptoms and dysautonomia. Confirmation often relies on specialized tests such as quantitative sensory testing (QST) and sympathetic skin response (SSR). This prospective, single-center observational diagnostic-accuracy study will estimate the performance of the Water-Immersion Wrinkle Test (WIWT) for detecting SFN in adults evaluated by a neuromuscular service. The composite reference standard is specialist clinical assessment plus abnormality on ≥1 validated scale (Utah Early Neuropathy Scale \[UENS\] or modified Toronto Clinical Neuropathy Score \[mTCNS\]). The index procedure (WIWT) is standardized as follows: both hands immersed to at least the distal interphalangeal crease for 15 minutes; immersion begins at 43-44 °C with expected passive cooling of \~2 °C every 5 minutes; temperature measured at 0, 5, 10 and 15 minutes; no water is added or replaced during immersion. After gentle drying, standardized photographs are obtained and wrinkling grades (0-4) are recorded for digits 2-5; the bilateral summed score is classified abnormal \<24 and normal ≥24. Examiners for WIWT, QST, and SSR are mutually blinded. The primary outcome is WIWT sensitivity and specificity versus the composite reference at baseline. Secondary outcomes include ROC area under the curve (AUC), positive/negative predictive values, and inter- and intra-rater reliability (intraclass correlation coefficients). Recruitment is ongoing; anticipated primary completion: November 2025.

Conditions

  • Small-Fiber Neuropathy
  • Dysautonomia

Sponsors & Collaborators

  • HOSPITAL BRITANICO DE BUENOS AIRES

    lead OTHER

Principal Investigators

  • Lucas A Piedrafita Vico, MD · Hospital Británico de Buenos Aires

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2025-11-01
Completion
2025-11-20

Countries

  • Argentina

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07255573 on ClinicalTrials.gov