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| Name | Class |
|---|---|
| Centro Hospitalar do Porto | OTHER |
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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| 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 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease duration | Diabetes duration until the assessment day will be noted. | At study entry |
| Type of diabetes | The type of diabetes (Type I or Type II) will be assessed. |
Inclusion Criteria:
Exclusion Criteria:
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Patients with established diagnosis of diabetic foot. Diabetic Foot is related to infection, ulceration or destruction of tissues of the foot associated with neuropathy and/or peripheral artery disease in the lower extremity of people with diabetes.
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| Name | Affiliation | Role |
|---|---|---|
| Adérito RD Seixas, MSc | Universidade do Porto | Principal Investigator |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| D003920 | Diabetes Mellitus |
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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| 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 |
| At study entry |
| Foot deformity | The presence of claw toes, hammer toes, hallux valgus, flat foot, increased foot arch and Charcot will be assessed. | At study entry |
| Amputation | The presence of minor amputation will be assessed. | At study entry |
| Neuropathy | The presence of neuropathy will be assessed according to the criteria of the International Working Group on the Diabetic Foot. | At study entry |
| Peripheral artery disease | Peripheral artery disease signs - an absence of foot pulses and intermittent claudication - will be assessed. | At study entry |
| Generic health status | The generic health status will be assessed with the EQ-5D-5L instrument. | At study entry |
| Age | The age of participants at the assessment day will be noted. | At study entry |
| Height | The height of participants at the assessment day will be noted. | At study entry |
| Weight | The weight of participants at the assessment day will be noted. | At study entry |
| Body mass index | Body mass index will be calculated from the height and weight of the participants. | At study entry |
| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D016491 | Peripheral Vascular Diseases |