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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03254095

Enrollment

Registered

2017-08-18

Start date

2016-09-01

Completion date

2018-09-30

Last updated

2019-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetic Foot

Keywords

Skin temperature, Plantar pressure, Diabetic foot, Tissue hardness, Neuropathy, Peripheral artery disease

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Skin temperature	At study entry	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.
Barefoot plantar pressure	At study entry	Barefoot plantar pressure will be assessed using a pressure platform.
Percentage of patients developing a foot ulcer	One year after enrollment	The occurrence of foot ulceration will be assessed during a period of 1 year.

Secondary

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

Other

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

Outcome results