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

NCT ID: NCT03254095

Last Updated: 2019-04-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 54 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-09-01
• Study Completion Date: 2018-09-30

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.

Conditions

Diabetic Foot; Diabetes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centro Hospitalar do Porto

OTHER

Sponsor Role: collaborator

Universidade do Porto

OTHER

Sponsor Role: lead

Responsible Party

Adérito Seixas

PhD Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adérito RD Seixas, MSc

Role: PRINCIPAL_INVESTIGATOR

Universidade do Porto

Other Identifiers

FADEUP_PhD_AdéritoSeixas#1

Identifier Type: -

Identifier Source: org_study_id