Diabetic FootNCT03254095
Predictors of Skin Temperature, Plantar Pressure and Ulceration in Diabetic Foot Patients.
An observational study of Diabetic Foot and Diabetes, run by Universidade do Porto.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetic Foot, Diabetes
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2016to 30 Sep 2018
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Adults (over 18 years)
- Diagnosed as diabetic foot patient
- Able to walk 10 meters without assistance
Who cannot join
- Non-cooperating patients
- Patients with major amputations
- Patients with a draining ulcer and/or infection
- Patients with cognitive impairments
About this study
Official title: Thermal and Biomechanical Characterization of Diabetic Foot Patients, Predictors of Skin Temperature, Barefoot Plantar Pressure and Ulceration.
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
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus, Peripheral Arterial Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At study entry
Barefoot plantar pressure
Barefoot plantar pressure will be assessed using a pressure platform.
Measured: At study entry
Percentage of patients developing a foot ulcer
The occurrence of foot ulceration will be assessed during a period of 1 year.
Measured: One year after enrollment
Secondary outcomes (5)
Ankle mobility
Active ankle mobility (dorsiflexion and plantarflexion) will be assessed with a goniometer.
Measured: At study entry
Hallux active extension range of movement
Hallux active extension mobility will be assessed with a goniometer.
Measured: At study entry
Soft tissue hardness
Soft tissue hardness will be assessed with a durometer.
Measured: At study entry
In-shoe plantar pressure
In-shoe plantar pressure will be assessed using an insole system.
Measured: At study entry
Time to ulceration
The time to ulcer occurrence will be assessed.
Measured: At study entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2017
- Study start1 Sep 2016
- Primary completion31 May 2017
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Collaborators
- Centro Hospitalar do Porto
- Responsible party
- Principal investigator, Adérito Seixas, Universidade do Porto
- Investigators
- Adérito RD Seixas, MSc, Principal investigator, Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03254095
- Sponsor's protocol ID
- FADEUP_PhD_AdéritoSeixas#1
- Status last verified
- Apr 2019
- First submitted
- 12 Aug 2017
- Last updated
- 16 Apr 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thermal and Biomechanical Characterization of Diabetic Foot Patients, Predictors of Skin Temperature, Barefoot Plantar Pressure and Ulceration.
- ClinicalTrials.gov ID
- NCT03254095
- Acronym / sponsor ID
- FADEUP_PhD_AdéritoSeixas#1
- Conditions
- Diabetic Foot, Diabetes
- Keywords
- Skin temperature, Plantar pressure, Diabetic foot, Tissue hardness, Neuropathy, Peripheral artery disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Collaborators
- Centro Hospitalar do Porto
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 18 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Adults (over 18 years)
- Diagnosed as diabetic foot patient
- Able to walk 10 meters without assistance
Key exclusion criteria (4 listed)
- Non-cooperating patients
- Patients with major amputations
- Patients with a draining ulcer and/or infection
- Patients with cognitive impairments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Barefoot plantar pressure
Time frame: At study entry
Barefoot plantar pressure will be assessed using a pressure platform.
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.
5 secondary outcomes
Ankle mobility
Time frame: At study entry
Hallux active extension range of movement
Time frame: At study entry
Soft tissue hardness
Time frame: At study entry
In-shoe plantar pressure
Time frame: At study entry
Time to ulceration
Time frame: At study entry
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
Related trials for Diabetic Foot
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PAW-Hydrogel for Chronic Wound Healing
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Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
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Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adérito RD Seixas, MSc principal investigator
Universidade do Porto
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Foot and Diabetes, run by Universidade do Porto.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin temperature (time frame: At study entry). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.