Predictors of Skin Temperature, Plantar Pressure and Ulceration in Diabetic Foot Patients.

Thermal and Biomechanical Characterization of Diabetic Foot Patients, Predictors of Skin Temperature, Barefoot Plantar Pressure and Ulceration.

Diabetes is a chronic disease with increasing prevalence worldwide with a high burden to individuals and the society and it is expected to be the 7th leading cause of death in 2030. Diabetes related complications manifest in many body parts, often in the foot, due to reduced blood flow and nerve damage, increasing the risk of ulcers and amputation. High plantar pressures during walking contribute to the development of foot ulcers and foot ulcer recurrence. Emerging studies also point skin temperature as another predictor of foot ulceration. However, the number of studies including prediction models of plantar pressure and skin temperature are scarce, especially in patients with confirmed diagnosis of diabetic foot and a history of foot ulcer. Factors like mobility, hardness of plantar soft tissue, foot deformities and other diabetes related characteristics have been related to plantar pressure measurements but not to foot skin temperature measurements, and the relation between skin temperature and plantar pressure has not been much explored in the literature. The role of these variables in the development of foot ulceration needs further attention, especially in patients with history of foot ulcers has they are at the highest risk to develop a foot ulcer.

Therefore, the goal of this research is to determine which variables can be used to predict plantar pressure and skin temperature and which factors are associated with the development of foot ulcers in patients with established diagnosis of diabetic foot. The associations between skin temperature and plantar pressure will also be addressed.

Study Overview

• Status: Completed
• Conditions: Diabetes; Diabetic Foot

• Study Type: Observational
• Enrollment (Actual): 54

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with established diagnosis of diabetic foot. Diabetic Foot is related to infection, ulceration or destruction of tissues of the foot associated with neuropathy and/or peripheral artery disease in the lower extremity of people with diabetes.

Description

Inclusion Criteria:

• Adults (over 18 years)
• Diagnosed as diabetic foot patient
• Able to walk 10 meters without assistance

Exclusion Criteria:

• Non-cooperating patients
• Patients with major amputations
• Patients with a draining ulcer and/or infection
• Patients with cognitive impairments

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin temperature	After an acclimation period of 10 minutes, skin temperature of the sole and dorsum of the foot will be assessed with a thermographic camera. Thermograms will be captured before, immediately after and five minutes after a two-minute cold stress test using an aluminium plaque.	At study entry
Barefoot plantar pressure	Barefoot plantar pressure will be assessed using a pressure platform.	At study entry
Percentage of patients developing a foot ulcer	The occurrence of foot ulceration will be assessed during a period of 1 year.	One year after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ankle mobility	Active ankle mobility (dorsiflexion and plantarflexion) will be assessed with a goniometer.	At study entry
Hallux active extension range of movement	Hallux active extension mobility will be assessed with a goniometer.	At study entry
Soft tissue hardness	Soft tissue hardness will be assessed with a durometer.	At study entry
In-shoe plantar pressure	In-shoe plantar pressure will be assessed using an insole system.	At study entry
Time to ulceration	The time to ulcer occurrence will be assessed.	At study entry

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease duration	Diabetes duration until the assessment day will be noted.	At study entry
Type of diabetes	The type of diabetes (Type I or Type II) will be assessed.	At study entry
Foot deformity	The presence of claw toes, hammer toes, hallux valgus, flat foot, increased foot arch and Charcot will be assessed.	At study entry
Amputation	The presence of minor amputation will be assessed.	At study entry
Neuropathy	The presence of neuropathy will be assessed according to the criteria of the International Working Group on the Diabetic Foot.	At study entry
Peripheral artery disease	Peripheral artery disease signs - an absence of foot pulses and intermittent claudication - will be assessed.	At study entry
Generic health status	The generic health status will be assessed with the EQ-5D-5L instrument.	At study entry
Age	The age of participants at the assessment day will be noted.	At study entry
Height	The height of participants at the assessment day will be noted.	At study entry
Weight	The weight of participants at the assessment day will be noted.	At study entry
Body mass index	Body mass index will be calculated from the height and weight of the participants.	At study entry

Collaborators and Investigators

• Sponsor: Universidade do Porto
• Collaborators: Centro Hospitalar do Porto
• Investigators: Principal Investigator: Adérito RD Seixas, MSc, Universidade do Porto

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): May 31, 2017
• Study Completion (Actual): September 30, 2018

Study Registration Dates

• First Submitted: August 12, 2017
• First Submitted That Met QC Criteria: August 15, 2017
• First Posted (Actual): August 18, 2017

Study Record Updates

• Last Update Posted (Actual): April 16, 2019
• Last Update Submitted That Met QC Criteria: April 15, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Neuropathy; Diabetic foot; Peripheral artery disease; Skin temperature; Plantar pressure; Tissue hardness
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Ulcer; Diabetic Foot
• Other Study ID Numbers: FADEUP_PhD_AdéritoSeixas#1