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Validere termografisk kamera for fotvurdering ved diabetes (HIK-DM-2026)

3. august 2026 oppdatert av: Eduardo Luis Martín Javier

Validierung av termografisk kamera for vurdering av diabetisk fot

Denne tverrsnittsstudien validerer samsvaret mellom et lavkostnadstermografikamera (HIKMICRO Mini2 V2, ~200 euro) og en profesjonell klinisk standard (HIKMICRO M60) for vurdering av diabetisk fot.
Begge kameraene tar samtidig termografiske bilder av fotsålen fra 130 deltakere med diabetes mellitus.
Maksimal kontralateral termisk asymmetri (Delta T_max) over 6 plantare ROIs er hovedendepunktet, analysert med ICC og Bland-Altman-metoden.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Antatt)

130

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Spania
    • Santa Cruz de Tenerife
      • San Cristóbal de La Laguna, Santa Cruz de Tenerife, Spania, 38201
        • Clínica Avanza Salud
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

N/A

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Pasienter med type 1 eller type 2 diabetes mellitus som kommer til poliklinikken for screening og vurdering av diabetisk fot.

Beskrivelse

Inklusjonskriterier:

  • Alder 18 år eller eldre.
  • Diagnostisert med type 1 eller type 2 diabetes mellitus.
  • Evne til å forstå og signere informert samtykke.

Eksklusjonskriterier:

  • Aktive fotsår.
  • Nylig operasjon på nedre ekstremiteter.
  • Kognitiv svikt som hindrer følging av studioprotokollen.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
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.
Enhet: 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.
Enhet: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
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
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Eduardo Luis Martín Javier

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. oktober 2026

Primær fullføring (Antatt)

1. april 2027

Studiet fullført (Antatt)

1. juli 2027

Datoer for studieregistrering

Først innsendt

5. mars 2026

Først innsendt som oppfylte QC-kriteriene

5. mars 2026

Først lagt ut (Faktiske)

11. mars 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. august 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • HIK-DM-2026-01
  • CHUC_2026_24 (Annen identifikator: CEIm Provincial de Santa Cruz de Tenerife, Complejo Hospitalario Universitario de Canarias)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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