EO2 Oxygen Delivery To Study Success Rate of Surgically Closed Wounds
NCT03960463
Amputation Wound, Arterial Occlusive Diseases
Houston, Texas, United States
View Trial DetailsNCT Number: NCT03254095
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.
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Notify Me18 year and older
All sexes
Observational
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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.
Time frame: At study entry
Barefoot plantar pressure will be assessed using a pressure platform.
Time frame: One year after enrollment
The occurrence of foot ulceration will be assessed during a period of 1 year.
Time frame: At study entry
Active ankle mobility (dorsiflexion and plantarflexion) will be assessed with a goniometer.
Time frame: At study entry
Hallux active extension mobility will be assessed with a goniometer.
Time frame: At study entry
Soft tissue hardness will be assessed with a durometer.
Time frame: At study entry
In-shoe plantar pressure will be assessed using an insole system.
Time frame: At study entry
The time to ulcer occurrence will be assessed.
Time frame: At study entry
Diabetes duration until the assessment day will be noted.
Time frame: At study entry
The type of diabetes (Type I or Type II) will be assessed.
Time frame: At study entry
The presence of claw toes, hammer toes, hallux valgus, flat foot, increased foot arch and Charcot will be assessed.
Time frame: At study entry
The presence of minor amputation will be assessed.
Time frame: At study entry
The presence of neuropathy will be assessed according to the criteria of the International Working Group on the Diabetic Foot.
Time frame: At study entry
Peripheral artery disease signs - an absence of foot pulses and intermittent claudication - will be assessed.
Time frame: At study entry
The generic health status will be assessed with the EQ-5D-5L instrument.
Time frame: At study entry
The age of participants at the assessment day will be noted.
Time frame: At study entry
The height of participants at the assessment day will be noted.
Time frame: At study entry
The weight of participants at the assessment day will be noted.
Time frame: At study entry
Body mass index will be calculated from the height and weight of the participants.
Universidade do Porto
Other
Thermal and Biomechanical Characterization of Diabetic Foot Patients, Predictors of Skin Temperature, Barefoot Plantar Pressure and Ulceration.
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