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

Completed

• Conditions: Diabetes; Diabetic Foot

• Registration Number: NCT03254095
• Lead Sponsor: Universidade do Porto

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-01
• Primary Completion: 2017-05-31
• Study First Submitted: 2017-08-12
• Study First Submitted QC: 2017-08-15
• Study First Posted: 2017-08-18
• Study Completion: 2018-09-30
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-15
• Last Update Posted: 2019-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.
Ankle mobility	At study entry	Active ankle mobility (dorsiflexion and plantarflexion) will be assessed with a goniometer.
In-shoe plantar pressure	At study entry	In-shoe plantar pressure will be assessed using an insole system.
Time to ulceration	At study entry	The time to ulcer occurrence will be assessed.