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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03254095
Recruitment Status : Completed
First Posted : August 18, 2017
Last Update Posted : April 16, 2019
Centro Hospitalar do Porto
Information provided by (Responsible Party):
Adérito Seixas, Universidade do Porto

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.

Condition or disease
Diabetic Foot Diabetes

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Study Type : Observational [Patient Registry]
Actual Enrollment : 54 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Thermal and Biomechanical Characterization of Diabetic Foot Patients, Predictors of Skin Temperature, Barefoot Plantar Pressure and Ulceration.
Actual Study Start Date : September 1, 2016
Actual Primary Completion Date : May 31, 2017
Actual Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03254095

Sponsors and Collaborators
Universidade do Porto
Centro Hospitalar do Porto
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Principal Investigator: Adérito RD Seixas, MSc Universidade do Porto

Additional Information:

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Responsible Party: Adérito Seixas, PhD Student, Universidade do Porto Identifier: NCT03254095     History of Changes
Other Study ID Numbers: FADEUP_PhD_AdéritoSeixas#1
First Posted: August 18, 2017    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019

Keywords provided by Adérito Seixas, Universidade do Porto:
Skin temperature
Plantar pressure
Diabetic foot
Tissue hardness
Peripheral artery disease

Additional relevant MeSH terms:
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Diabetic Foot
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies