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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03254095
• Other study ID #: FADEUP_PhD_AdéritoSeixas#1
• Status: Completed
• Start date: September 1, 2016
• Est. completion date: September 30, 2018

Study information

• Verified date: April 2019
• Source: Universidade do Porto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: September 30, 2018
• Est. primary completion date: May 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetic Foot

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Universidade do Porto	Centro Hospitalar do Porto

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Disease duration	Diabetes duration until the assessment day will be noted.	At study entry
Other	Type of diabetes	The type of diabetes (Type I or Type II) will be assessed.	At study entry
Other	Foot deformity	The presence of claw toes, hammer toes, hallux valgus, flat foot, increased foot arch and Charcot will be assessed.	At study entry
Other	Amputation	The presence of minor amputation will be assessed.	At study entry
Other	Neuropathy	The presence of neuropathy will be assessed according to the criteria of the International Working Group on the Diabetic Foot.	At study entry
Other	Peripheral artery disease	Peripheral artery disease signs - an absence of foot pulses and intermittent claudication - will be assessed.	At study entry
Other	Generic health status	The generic health status will be assessed with the EQ-5D-5L instrument.	At study entry
Other	Age	The age of participants at the assessment day will be noted.	At study entry
Other	Height	The height of participants at the assessment day will be noted.	At study entry
Other	Weight	The weight of participants at the assessment day will be noted.	At study entry
Other	Body mass index	Body mass index will be calculated from the height and weight of the participants.	At study entry
Primary	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
Primary	Barefoot plantar pressure	Barefoot plantar pressure will be assessed using a pressure platform.	At study entry
Primary	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	Ankle mobility	Active ankle mobility (dorsiflexion and plantarflexion) will be assessed with a goniometer.	At study entry
Secondary	Hallux active extension range of movement	Hallux active extension mobility will be assessed with a goniometer.	At study entry
Secondary	Soft tissue hardness	Soft tissue hardness will be assessed with a durometer.	At study entry
Secondary	In-shoe plantar pressure	In-shoe plantar pressure will be assessed using an insole system.	At study entry
Secondary	Time to ulceration	The time to ulcer occurrence will be assessed.	At study entry