Foot Assessment in People With Diabetes: A Quantitative Diagnostic Approach

Staffordshire University

Status: Suspended

Conditions: Diabetes Complications; Diabetic Foot; Diabetes; Diabetes; Neuropathic (Manifestation)

Treatments: Diagnostic Test: Observation

Study type: Observational

Funder types: Other

Identifiers

NCT03089463

1

Details and patient eligibility

About

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

Full 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.

Enrollment: 153 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 1 OR 2 diabetes
• Over 18
• English speaking
• Ability to walk unaided over 5m
• Diabetic neuropathy as defined by a 10g monofilament test

Exclusion criteria

• Lower limb surgery (amputation)
• 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

Trial design

153 participants in 1 patient group

Observation group

Description:

The entire participants in this study will be included in this group.

Treatment:

Diagnostic Test: Observation