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NCT06933108Recruiting

Prediction of Peripheral Neuropathy With Functional Testing

Estimate the Risk of Diabetic and Uremic Peripheral Neuropathy Using Physical and Functional Testing

Source: ClinicalTrials.gov · Last updated 18 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

Diabetes and chronic kidney disease (CKD) are two distinct pathologies. The former is defined as an impairment in insulin production and/or utilization, while the latter refers to structural or functional abnormalities of the kidneys. However, these two diseases share a common complication: peripheral neuropathy. This condition affects between 50% and 60% of patients with diabetes or CKD. Peripheral neuropathy involves the destruction of sensory and motor neurons, leading to a wide range of painful symptoms while also reducing force production capacity. Among the diagnostic tests used, the most accessible clinical tests suffer from high variability due to human subjectivity (e.g., the tuning fork test, which requires examiner expertise and verbal patient feedback), whereas laboratory electrophysiological tests can only detect the largest neurons, which are affected at later stages. Although composite clinical tests have been developed to improve neuropathy screening performance, they still inherit the limitations of their individual components. In other words, they remain subject to variability related to the examiner's experience and the patient's ability to understand instructions, while also being performed through various procedures that lack a standardized consensus. Moreover, these composite scores are particularly time-consuming and are therefore rarely used in clinical practice. As a result, no method currently allows for large-scale, early, and reliable screening of peripheral neuropathy. Our recent work and emerging studies suggest that assessing functional capacities could serve as an objective and early marker of neuropathic impairment, even before clinical diagnosis. Specifically, the quantification of postural balance performance using stabilometric methods (i.e., center of pressure displacement area) and unipedal balance time could predict the presence of diabetes-related peripheral neuropathy with over 95% accuracy compared to diagnosis with a composite clinical method (unpublished results). Therefore, the aim of this study is to evaluate physical and balance capacities assessed during routine care in adapted physical activity settings, in order to determine whether the development of a composite score could help estimate the risk of peripheral neuropathy in individuals with diabetes and CKD.

Status (registry)
Recruiting
Study type
Observational
Enrollment
70 (estimated)
First submitted
26 Mar 2025
Start date
27 Jan 2025
Primary completion date
2 May 2025
Lead sponsor
Université catholique de l'Ouest
NCT number
NCT06933108

What you commit to

  • Study type: Observational
  • Planned participants: 70
  • From 27 Jan 2025 to the primary completion date, 2 May 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Musculoskeletal, osteorarticular and neurological disease(s)
  • Cognitive impairment

Other

  • Currently or planning dialysis
  • Low-limb amputation

Who the study is looking for

  • CKD stage 4-5 and / or diabetes (Type I or II)
  • Able to walk 20 m
  • BMI \< 35

Age in the registry: 60 years to 80 years · Sex: All

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Centre Hospitalier Le Mans
Coordinator of this site? Confirm its status
Le MansFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.

Prediction of Peripheral Neuropathy With Functional Testing (NCT06933108) – Frontlight Research