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Foot Assessment in People With Diabetes: A Quantitative Diagnostic Approach

NCT03089463 · Status: SUSPENDED · Type: OBSERVATIONAL · Enrollment: 153

Last updated 2023-04-18

No results posted yet for this study

Summary

This observational cohort study aims to develop a novel risk stratification system implementing biomechanics to aid in the prevention of diabetic foot ulcers.

Conditions

  • Diabetes
  • Diabetic Foot
  • Diabetes Complications
  • Diabetes; Neuropathic (Manifestation)

Interventions

DIAGNOSTIC_TEST

Observation

The primary objective is to employ the measurements of neuropathy, micro/macro-perfusion, and biomechanics of the foot mainly tissue stiffness and plantar pressure to determine the vulnerability of foot to mechanical trauma and ulceration. From the data collected it is proposed that a prognostic risk stratification system will be developed based on the range of parameters collected to identify those that are at highest risk of ulceration incident. Those that are classed as high risk are to be sub-stratified to increase the accuracy of the system in predicting ulceration. This will allow a patient-specific approach to be taken in the prevention of ulcers by providing adequate information to predict ulceration incident.

Sponsors & Collaborators

  • Staffordshire University

    lead OTHER

Principal Investigators

  • Roozbeh Naemi, PhD · Staffordshire University

  • Nachiappan Chockalingam · Staffordshire University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-27
Primary Completion
2024-11-30
Completion
2025-01-30

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

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 NCT03089463 on ClinicalTrials.gov