Diabetes MellitusNCT07463456
Inter-Device Concordance of Plantar Thermal Asymmetry Measurement (HIK-DM-2026)
An observational study of Diabetes Mellitus, run by Eduardo Luis Martín Javier at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- HIKMICRO® Mini2 V2 and HIKMICRO® M60
- Type of treatment
- Medical device
- How many people
- 130 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2026to Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Clínica Avanza Salud
San Cristóbal de La Laguna, Santa Cruz de Tenerife, 38201
Eduardo Luis Martín Javier, +34 647 773 675, eduardo@avanza-salud.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetes Mellitus
- Being tested
- HIKMICRO® Mini2 V2, HIKMICRO® M60
- Keywords
- thermography, infrared, concordance, ICC, low-cost, HIKMICRO, plantar temperature, inter-device concordance, intraclass correlation coefficient, thermal asymmetry, agreement study, measurement reproducibility
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIKMICRO® Mini2 V2Device
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.
HIKMICRO® M60Device
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: HIKMICRO® Mini2 V2; Device: HIKMICRO® M60 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Measured: Single measurement session (Day 1)
Secondary outcomes (8)
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
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.
Measured: Single measurement session (Day 1)
Consistency intraclass correlation coefficient, ICC(C,1), between the two cameras for mean plantar temperature (Tmean)
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.
Measured: 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)
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.
Measured: Single measurement session (Day 1)
Influence of participant clinical variables on the magnitude of inter-device discordance
The absolute inter-device difference is analyzed against the presence of peripheral sensory neuropathy, body mass index and type of diabetes mellitus.
Measured: Single measurement session (Day 1)
Image acquisition time
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.
Measured: Single measurement session (Day 1)
Proportion of technically valid thermograms
Percentage of thermographic acquisitions that did not require repetition because of a technical error, namely defocus, participant movement or a saving failure.
Measured: Single measurement session (Day 1)
Participant acceptability of the measurement protocol
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.
Measured: Single measurement session (Day 1)
Descriptive distribution of the maximum contralateral thermal asymmetry per participant
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.
Measured: Single measurement session (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study startOct 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Cross-sectional
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eduardo Luis Martín Javier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eduardo Luis Martín Javier, Universidad Europea de Canarias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07463456
- Sponsor's protocol ID
- HIK-DM-2026-01
- Other IDs
- CHUC_2026_24
- Status last verified
- Sep 2026
- First submitted
- 5 Mar 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07463456
- Acronym / sponsor ID
- HIK-DM-2026-01
- Conditions
- Diabetes Mellitus
- Keywords
- thermography, infrared, concordance, ICC, low-cost, HIKMICRO, plantar temperature, inter-device concordance
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Eduardo Luis Martín JavierUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 11 Mar 2026 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetes patients | – | Device: HIKMICRO® Mini2 V2, Device: HIKMICRO® M60Adults with diagnosed type 1 or type 2 diabetes mellitus, without active plantar ulceration, recruited from the active caseload of general podiatry and physiotherapy consultations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIKMICRO® Mini2 V2Low-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 | Diabetes patients |
| HIKMICRO® M60High-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. | Device | Diabetes patients |
Primary outcome
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.
8 secondary outcomes
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)
Consistency intraclass correlation coefficient, ICC(C,1), between the two cameras for mean plantar temperature (Tmean)
Time frame: 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)
Influence of participant clinical variables on the magnitude of inter-device discordance
Time frame: Single measurement session (Day 1)
Image acquisition time
Time frame: Single measurement session (Day 1)
Proportion of technically valid thermograms
Time frame: Single measurement session (Day 1)
Participant acceptability of the measurement protocol
Time frame: Single measurement session (Day 1)
Descriptive distribution of the maximum contralateral thermal asymmetry per participant
Time frame: Single measurement session (Day 1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by Eduardo Luis Martín Javier at 1 site in Spain.
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 4 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eduardo Luis Martín Javier (+34 647 773 675, eduardo@avanza-salud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). 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 30 Sep 2026.