Foot Assessment in People With Diabetes: A Quantitative Diagnostic Approach
NCT ID: NCT03089463
Last Updated: 2023-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
153 participants
OBSERVATIONAL
2017-11-27
2025-01-30
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Observation group
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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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Over 18
* English speaking
* Ability to walk unaided over 5m
* Diabetic neuropathy as defined by a 10g monofilament test
Exclusion Criteria
* Active ulcers
* History of neurological disorders (apart from neuropathy)
* Orthopaedic problems
* Systemic disease affecting mobility or leading to chronic inflammation of any lower limb joint.
* Visual impairment leading to difficulties in walking
* Charcot foot
* Unable to walk unaided for 5m
18 Years
ALL
No
Sponsors
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Staffordshire University
OTHER
Responsible Party
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Roozbeh Naemi
Associate Professor of Biomechanics
Principal Investigators
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Roozbeh Naemi, PhD
Role: PRINCIPAL_INVESTIGATOR
Staffordshire University
Nachiappan Chockalingam
Role: STUDY_CHAIR
Staffordshire University
Locations
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Staffordshire University
Stoke-on-Trent, Staffordshire, United Kingdom
Countries
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Other Identifiers
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1
Identifier Type: -
Identifier Source: org_study_id
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