Inter-Device Concordance of Plantar Thermal Asymmetry Measurement (HIK-DM-2026)

August 3, 2026 updated by: Eduardo Luis Martín Javier

Inter-Device Concordance in the Measurement of Plantar Thermal Asymmetry: Comparative Evaluation of a Low-Cost Thermographic Camera (HIKMICRO Mini2 V2) Versus a High-Resolution Camera (HIKMICRO M60) in Patients With Diabetes Mellitus

This cross-sectional observational study measures the inter-device concordance between two infrared thermographic cameras, a low-cost model (HIKMICRO Mini2 V2) and a high-resolution model (HIKMICRO M60), when measuring plantar skin temperature in adults with diabetes mellitus. Each participant undergoes two consecutive thermographic acquisitions, always less than 10 seconds apart, from a fixed tripod at 75 cm, under standardized environmental conditions. The order of the two cameras is randomized 1:1 at participant level (sequence A: M60 then Mini2 V2; sequence B: Mini2 V2 then M60). The primary endpoint is the agreement between the two devices for contralateral thermal asymmetry (Delta T) in each of six pre-specified plantar regions of interest (ROIs), quantified by the intraclass correlation coefficient (ICC) for absolute agreement, with the consistency ICC for mean plantar temperature (Tmean) as an exploratory endpoint.

The study is strictly metrological. Neither camera is a medical device under Regulation (EU) 2017/745, no clinical decision is derived from the measurements, and the study does not evaluate the detection, diagnosis, screening or prevention of any disease. Neither device is designated as a diagnostic reference standard. Participants with diabetes mellitus are included solely because plantar thermal variability is greater in this population, which makes the inter-device comparison metrologically demanding.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Each participant is assessed in a single session in a thermally stable room at 20 to 25 degrees Celsius, with relative humidity recorded as a covariate. After 15 minutes of acclimatization in a semi-Fowler position with the backrest at 30 to 45 degrees, both cameras acquire plantar thermograms from a static tripod at a fixed distance of 75 cm, with the tripod head at 90 degrees to the plantar plane and an emissivity setting of 0.98. The two radiometric acquisitions are consecutive and always less than 10 seconds apart. The order of the cameras is randomized 1:1 at participant level (sequence A: M60 then Mini2 V2; sequence B: Mini2 V2 then M60), from a list generated in advance by a team member not involved in image acquisition and kept in a password-protected file until recruitment is complete. No specific background is used.

Thermograms are exported to HIKMICRO Analyzer version 2.0.1. Six anatomical regions of interest, defined a priori and identical for both cameras, are delimited on each foot: hallux, first, third and fifth metatarsal heads, midfoot and heel. There is no post-hoc region selection and no indexing to either device. Contralateral thermal asymmetry (Delta T) is computed per region as the absolute difference in mean temperature between homologous regions of the right and left foot.

Images are renamed with an alphanumeric code that removes any explicit reference to the source device before analysis, and regions are delimited by an independent evaluator blinded to the neurological status of the participant. Technical blinding is acknowledged as partial, because the difference in spatial resolution between the two cameras may allow a trained evaluator to infer the source device.

The sample size follows the method of Walter, Eliasziw and Donner for the intraclass correlation coefficient, with a null hypothesis of ICC0 = 0.65 against an alternative of ICC1 = 0.80, alpha = 0.05, nominal power 0.80 and two observations per participant, which yields a minimum of 77 participants. The study enrolls 130 participants, which raises the actual power for this contrast to 95.7 percent and absorbs expected losses.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Spain
    • Santa Cruz de Tenerife
      • San Cristóbal de La Laguna, Santa Cruz de Tenerife, Spain, 38201
        • Clínica Avanza Salud
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Adults with type 1 or type 2 diabetes mellitus recruited from the active caseload of general podiatry and physiotherapy consultations. Participants with a disability who require support in decision making or in expressing consent may take part with the participation and signature of their legal representative or designated support person, in accordance with Spanish Law 8/2021 of 2 June.

Description

Inclusion Criteria:

  • Age 18 years or older.
  • Confirmed diagnosis of type 1 or type 2 diabetes mellitus.
  • Preserved plantar skin integrity at the time of the test.
  • Voluntary signature of the informed consent after receiving detailed information about the study.

Exclusion Criteria:

  • Active ulcers or open wounds in the plantar area, since exudation alters thermal emissivity.
  • Acute skin infection or extensive mycosis of the foot.
  • Previous partial amputation of the forefoot or midfoot that alters the anatomy of the regions of interest.
  • Severe peripheral arterial disease (Fontaine grade IV, critical ischemia) compromising tissue viability.
  • Physical or cognitive inability to remain in the semi-Fowler position (backrest 30 to 45 degrees) during the 15 minutes of the acclimatization protocol.
  • Intense physical activity or hydrotherapy within the 2 hours before the appointment, and caffeine intake or tobacco use within the same period, because of their vasoconstrictor effects.
  • Acute febrile state, body or tympanic temperature above 37.5 degrees Celsius at the time of the test.
  • Application of creams, moisturizing lotions, topical ointments or talcum powder to the plantar area within the 4 hours before the examination, because of the alteration of infrared emissivity and the evaporative cooling effect.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Diabetes patients
Adults with diagnosed type 1 or type 2 diabetes mellitus, without active plantar ulceration, recruited from the active caseload of general podiatry and physiotherapy consultations.
Device: HIKMICRO® Mini2 V2
Low-cost infrared thermographic camera (256 x 192 pixels, NETD below 40 mK) used solely as a measuring instrument. It is not a medical device and no clinical decision is derived from its readings.
Device: HIKMICRO® M60
High-resolution infrared thermographic camera (640 x 480 pixels, NETD below 35 mK) used as a technical comparator. It is not designated as a clinical or diagnostic reference standard.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Intraclass correlation coefficient for absolute agreement, ICC(A,1), between the two cameras for contralateral thermal asymmetry (Delta T) in each of six pre-specified plantar regions of interest
Time Frame: Single measurement session (Day 1)
Delta T is computed per region as the absolute difference in mean temperature between homologous regions of the right and left foot. One ICC(A,1) is reported for each of the six regions defined a priori (hallux, first, third and fifth metatarsal heads, midfoot and heel), with its 95 percent confidence interval, using the McGraw and Wong (1996) formulation, equivalent to ICC(2,1) of Shrout and Fleiss (1979), two-way random effects, single measurement. Each region contributes 130 paired measurements. The study hypothesis is ICC greater than or equal to 0.80, tested against a null of ICC0 = 0.65. Neither device is treated as a reference standard.
Single measurement session (Day 1)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cohen's Kappa for inter-device agreement in the binary classification of thermal asymmetry at the 2.2 degree Celsius cut-off, per region of interest
Time Frame: Single measurement session (Day 1)
Overall agreement proportion and Kappa with 95 percent confidence interval for the dichotomous classification Delta T greater than or equal to 2.2 degrees Celsius versus below it, in each of the six regions. The cut-off is used as an operational category without clinical connotation, and neither device is designated as the diagnostic reference.
Single measurement session (Day 1)
Consistency intraclass correlation coefficient, ICC(C,1), between the two cameras for mean plantar temperature (Tmean)
Time Frame: Single measurement session (Day 1)
McGraw and Wong (1996) consistency formulation, equivalent to ICC(3,1) of Shrout and Fleiss (1979), reported with its 95 percent confidence interval. Exploratory endpoint with a hypothesis of ICC greater than or equal to 0.75. It is not powered by an independent sample size calculation.
Single measurement session (Day 1)
Bland-Altman systematic bias and 95 percent limits of agreement between the two cameras for mean plantar temperature (Tmean) and for contralateral thermal asymmetry (Delta T)
Time Frame: Single measurement session (Day 1)
Systematic bias and 95 percent limits of agreement computed across the six pre-specified plantar regions of interest, for both the mean plantar temperature and the contralateral thermal asymmetry. Neither device is treated as a reference standard.
Single measurement session (Day 1)
Influence of participant clinical variables on the magnitude of inter-device discordance
Time Frame: Single measurement session (Day 1)
The absolute inter-device difference is analyzed against the presence of peripheral sensory neuropathy, body mass index and type of diabetes mellitus.
Single measurement session (Day 1)
Image acquisition time
Time Frame: Single measurement session (Day 1)
Time elapsed from the end of the acclimatization period to the correct export of both thermograms, measured with a stopwatch for each participant and reported in seconds.
Single measurement session (Day 1)
Proportion of technically valid thermograms
Time Frame: Single measurement session (Day 1)
Percentage of thermographic acquisitions that did not require repetition because of a technical error, namely defocus, participant movement or a saving failure.
Single measurement session (Day 1)
Participant acceptability of the measurement protocol
Time Frame: Single measurement session (Day 1)
Number of participants answering yes to a single dichotomous question asked verbally at the end of the session, on whether they would consider repeating this procedure at a future appointment.
Single measurement session (Day 1)
Descriptive distribution of the maximum contralateral thermal asymmetry per participant
Time Frame: Single measurement session (Day 1)
Median and interquartile range reported separately for each camera. This measure is descriptive only. It is not the primary criterion and it is not indexed to either device.
Single measurement session (Day 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eduardo Luis Martín Javier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 5, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 11, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HIK-DM-2026-01
  • CHUC_2026_24 (Other Identifier: CEIm Provincial de Santa Cruz de Tenerife, Complejo Hospitalario Universitario de Canarias)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings