Clinical trial NCT03254095: Predictors of Skin Temperature, Plantar Pressure and Ulceration in Diabetic Foot Patients.
Official title: Thermal and Biomechanical Characterization of Diabetic Foot Patients, Predictors of Skin Temperature, Barefoot Plantar Pressure and Ulceration.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Foot
Diabetes
Keywords: Skin temperature
Plantar pressure
Diabetic foot
Tissue hardness
Neuropathy
Peripheral artery disease
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
Collaborators: name: Centro Hospitalar do Porto
First posted: 2017-08-18
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


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

Primary outcomes:
measure: Skin temperature
timeFrame: At study entry
measure: Barefoot plantar pressure
timeFrame: At study entry
measure: Percentage of patients developing a foot ulcer
timeFrame: One year after enrollment
Secondary outcomes:
measure: Ankle mobility
timeFrame: At study entry
measure: Hallux active extension range of movement
timeFrame: At study entry
measure: Soft tissue hardness
timeFrame: At study entry
measure: In-shoe plantar pressure
timeFrame: At study entry
measure: Time to ulceration
timeFrame: At study entry
Other outcomes:
measure: Disease duration
timeFrame: At study entry
measure: Type of diabetes
timeFrame: At study entry
measure: Foot deformity
timeFrame: At study entry
measure: Amputation
timeFrame: At study entry
measure: Neuropathy
timeFrame: At study entry
measure: Peripheral artery disease
timeFrame: At study entry
measure: Generic health status
timeFrame: At study entry
measure: Age
timeFrame: At study entry
measure: Height
timeFrame: At study entry
measure: Weight
timeFrame: At study entry
measure: Body mass index
timeFrame: At study entry
Locations:
Study officials:
affiliation: Universidade do Porto
name: Adérito RD Seixas, MSc
role: PRINCIPAL_INVESTIGATOR
References: