Clinical trial NCT03089463: Foot Assessment in People With Diabetes: A Quantitative Diagnostic Approach
Official title: Foot Assessment in People With Diabetes: A Quantitative Diagnostic Approach
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Diabetes
Diabetic Foot
Diabetes Complications
Diabetes; Neuropathic (Manifestation)
Keywords: Diabetes
Diabetic Foot
Biomechanics
Stratification
Diabetes Complications
Diabetes; Neuropathic (Manifestation)
Risk Factors
Prospective Studies
Lead sponsor: Staffordshire University
Sponsor class: OTHER
First posted: 2017-03-24
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants for this study will be recruited from the diabetic population of Staffordshire and Stoke-on-Trent Partnership and University Hospital North Midlands.

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Qualitative foot assessment
timeFrame: April 2017 to April 2018 every 6 weeks
measure: Skin assessment of the foot
timeFrame: April 2017 to April 2018 every 6 weeks
measure: Monofilament test
timeFrame: April 2017 to April 2018 every 6 weeks
measure: Tuning fork vibration test
timeFrame: April 2017 to April 2018 every 6 weeks
measure: Biothesiometry
timeFrame: April 2017 to April 2018 every 6 weeks
measure: Ankle Brachial Index
timeFrame: April 2017 to April 2018 every 6 weeks
measure: Transcutaneous oxygen pressure (TcPO2)
timeFrame: April 2017 to April 2018 every 6 weeks
measure: Skin Perfusion Pressure (SPP)
timeFrame: April 2017 to April 2018 every 6 weeks
measure: Ankle/foot strength - Dynamometer
timeFrame: April 2017 to April 2018 every 6 weeks
measure: Range of motion (ROM)
timeFrame: April 2017 to April 2018 every 6 weeks
measure: Foot Posture Index (FPI)
timeFrame: April 2017 to April 2018 every 6 weeks
measure: Range of motion during walking
timeFrame: April 2017 to April 2018 every 6 weeks
measure: Balance
timeFrame: April 2017 to April 2018 every 6 weeks
measure: Gait Analyses
timeFrame: April 2017 to April 2018 every 6 weeks
measure: Ultrasound elastography assessment
timeFrame: April 2017 to April 2018 every 6 weeks
measure: Blood test
timeFrame: April 2017 to April 2018 every 6 weeks
measure: Thermography
timeFrame: April 2017 to April 2018 every 6 weeks
measure: Barefoot Plantar pressure
timeFrame: April 2017 to April 2018 every 6 weeks
measure: In-shoe plantar pressure measurement
timeFrame: April 2017 to April 2018 every 6 weeks
measure: Perfusion measurement
timeFrame: April 2017 to April 2018 every 6 weeks
Secondary outcomes:
measure: Ulceration incident
timeFrame: April 2017 to April 2018 every 6 weeks
Other outcomes:
Locations:
city: Stoke-on-Trent
country: United Kingdom
facility: Staffordshire University
state: Staffordshire
Study officials:
affiliation: Staffordshire University
name: Roozbeh Naemi, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Staffordshire University
name: Nachiappan Chockalingam
role: STUDY_CHAIR
References: