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

Study Overview
=================
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.

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

Conditions
-----------------
Diabetic Foot, Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------
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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Skin temperature, Plantar pressure, Diabetic foot, Tissue hardness, Neuropathy, Peripheral artery disease