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Completed

NCT Number: NCT03254095

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

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. Barefoot plantar pressure

    Time frame: At study entry

    Barefoot plantar pressure will be assessed using a pressure platform.

  3. 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.

Secondary outcomes

  1. Ankle mobility

    Time frame: At study entry

    Active ankle mobility (dorsiflexion and plantarflexion) will be assessed with a goniometer.

  2. Hallux active extension range of movement

    Time frame: At study entry

    Hallux active extension mobility will be assessed with a goniometer.

  3. Soft tissue hardness

    Time frame: At study entry

    Soft tissue hardness will be assessed with a durometer.

  4. In-shoe plantar pressure

    Time frame: At study entry

    In-shoe plantar pressure will be assessed using an insole system.

  5. Time to ulceration

    Time frame: At study entry

    The time to ulcer occurrence will be assessed.

Other outcomes

  1. Disease duration

    Time frame: At study entry

    Diabetes duration until the assessment day will be noted.

  2. Type of diabetes

    Time frame: At study entry

    The type of diabetes (Type I or Type II) will be assessed.

  3. 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.

  4. Amputation

    Time frame: At study entry

    The presence of minor amputation will be assessed.

  5. 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.

  6. Peripheral artery disease

    Time frame: At study entry

    Peripheral artery disease signs - an absence of foot pulses and intermittent claudication - will be assessed.

  7. Generic health status

    Time frame: At study entry

    The generic health status will be assessed with the EQ-5D-5L instrument.

  8. Age

    Time frame: At study entry

    The age of participants at the assessment day will be noted.

  9. Height

    Time frame: At study entry

    The height of participants at the assessment day will be noted.

  10. Weight

    Time frame: At study entry

    The weight of participants at the assessment day will be noted.

  11. Body mass index

    Time frame: At study entry

    Body mass index will be calculated from the height and weight of the participants.

Sponsors and collaborators

Lead sponsor

Universidade do Porto

Other

Collaborators

  • Centro Hospitalar do Porto

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Aug 18, 2017
Registry last updated
Apr 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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