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

NCT03254095 | Completed

• 1 other identifier: FADEUP_PhD_AdéritoSeixas#1
• Study Type: observational
• Target: 54
• Locations: 0 countries
• Sites: N/A

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

Keywords

Skin temperature; Plantar pressure; Diabetic foot; Tissue hardness; Neuropathy; Peripheral artery disease

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (5)

• Ankle mobility

  At study entry

• Hallux active extension range of movement

  At study entry

• Soft tissue hardness

  At study entry

• In-shoe plantar pressure

  At study entry

• Time to ulceration

  At study entry

Other Outcomes (11)

• Disease duration

  At study entry

• Type of diabetes

  At study entry

• Foot deformity

  At study entry

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Adults (over 18 years)
• Diagnosed as diabetic foot patient
• Able to walk 10 meters without assistance

You may not qualify if:

• Non-cooperating patients
• Patients with major amputations
• Patients with a draining ulcer and/or infection
• Patients with cognitive impairments

Sponsors & Collaborators

• Universidade do Porto: lead
• Centro Hospitalar do Porto: collaborator

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus; Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Endocrine System Diseases; Diabetic Neuropathies; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases

Study Officials

• Adérito RD Seixas, MSc

  Universidade do Porto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: August 12, 2017
• First Posted: August 18, 2017
• Study Start: September 1, 2016
• Primary Completion: May 31, 2017
• Study Completion: September 30, 2018
• Last Updated: April 16, 2019

Record last verified: 2019-04