NCT03089463

Foot Assessment in People With Diabetes: A Quantitative Diagnostic Approach

• Status: Suspended
• Phase: —
• Study type: Observational
• Enrollment: 153 (estimated)
• Sponsor: Staffordshire University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

The purpose of this research observational cohort study is to investigate the applicability of using biomechanical assessment in predicting the ulceration incidence in patients with diabetic neuropathic feet. The proposed study will lead to the development of further stratification of high-risk patients into subcategories indicating the vulnerability of tissue to mechanical trauma, which deemed to be the leading cause of ulceration in people with diabetic neuropathy. As it stands, the current systems used to evaluate the risk of diabetic foot rely on global parameters such as duration of diabetes and glycated hemoglobin to predict the likelihood and risk of diabetic foot ulceration. As ulceration happens as a result of repeat mechanical trauma to the foot that doesn't heal quickly enough due to other complications of diabetes, it is important to include mechanical measurements in predicting the ulceration incident in diabetic neuropathic patients. Despite this, the currently used risk stratification systems do not include biomechanics so by introducing biomechanics it will potentially be possible to predict the ulceration risk by using more local measurements. The primary objective is to employ the measures 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. This then can be used to determine the likelihood of an ulcer forming. Furthermore, the possibility of identifying the ulceration site will be investigated.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-11-27
• Primary completion: 2024-11-30
• Completion: 2025-01-30
• First posted: 2017-03-24
• Last updated: 2023-04-18

Locations

1 site across 1 country: United Kingdom