Predictors of Skin Temperature, Plantar Pressure and Ulceration in Diabetic Foot Patients.
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|ClinicalTrials.gov Identifier: NCT03254095|
Recruitment Status : Completed
First Posted : August 18, 2017
Last Update Posted : April 16, 2019
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.
|Condition or disease|
|Diabetic Foot Diabetes|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||54 participants|
|Target Follow-Up Duration:||1 Year|
|Official Title:||Thermal and Biomechanical Characterization of Diabetic Foot Patients, Predictors of Skin Temperature, Barefoot Plantar Pressure and Ulceration.|
|Actual Study Start Date :||September 1, 2016|
|Actual Primary Completion Date :||May 31, 2017|
|Actual Study Completion Date :||September 30, 2018|
- Skin temperature [ 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.
- Barefoot plantar pressure [ Time Frame: At study entry ]Barefoot plantar pressure will be assessed using a pressure platform.
- Percentage of patients developing a foot ulcer [ Time Frame: One year after enrollment ]The occurrence of foot ulceration will be assessed during a period of 1 year.
- Ankle mobility [ Time Frame: At study entry ]Active ankle mobility (dorsiflexion and plantarflexion) will be assessed with a goniometer.
- Hallux active extension range of movement [ Time Frame: At study entry ]Hallux active extension mobility will be assessed with a goniometer.
- Soft tissue hardness [ Time Frame: At study entry ]Soft tissue hardness will be assessed with a durometer.
- In-shoe plantar pressure [ Time Frame: At study entry ]In-shoe plantar pressure will be assessed using an insole system.
- Time to ulceration [ Time Frame: At study entry ]The time to ulcer occurrence will be assessed.
- Disease duration [ Time Frame: At study entry ]Diabetes duration until the assessment day will be noted.
- Type of diabetes [ Time Frame: At study entry ]The type of diabetes (Type I or Type II) will be assessed.
- Foot deformity [ Time Frame: At study entry ]The presence of claw toes, hammer toes, hallux valgus, flat foot, increased foot arch and Charcot will be assessed.
- Amputation [ Time Frame: At study entry ]The presence of minor amputation will be assessed.
- Neuropathy [ 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.
- Peripheral artery disease [ Time Frame: At study entry ]Peripheral artery disease signs - an absence of foot pulses and intermittent claudication - will be assessed.
- Generic health status [ Time Frame: At study entry ]The generic health status will be assessed with the EQ-5D-5L instrument.
- Age [ Time Frame: At study entry ]The age of participants at the assessment day will be noted.
- Height [ Time Frame: At study entry ]The height of participants at the assessment day will be noted.
- Weight [ Time Frame: At study entry ]The weight of participants at the assessment day will be noted.
- Body mass index [ Time Frame: At study entry ]Body mass index will be calculated from the height and weight of the participants.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03254095
|Principal Investigator:||Adérito RD Seixas, MSc||Universidade do Porto|