Clinical Trials Directory

Trials / Completed

CompletedNCT03254095

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

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

Status
Completed
Phase
Study type
Observational
Enrollment
54 (actual)
Sponsor
Universidade do Porto · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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.

Conditions

Timeline

Start date
2016-09-01
Primary completion
2017-05-31
Completion
2018-09-30
First posted
2017-08-18
Last updated
2019-04-16

Source: ClinicalTrials.gov record NCT03254095. Inclusion in this directory is not an endorsement.