Validierung der thermografischen Kamera zur Beurteilung des diabetischen Fußes (HIK-DM-2026)
Validierung der thermografischen Kamera für die diabetische Fußbeurteilung
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Eduardo Luis Martín Javier
- Telefonnummer: +34 647 773 675
- E-Mail: eduardo@avanza-salud.com
Studienorte
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Santa Cruz de Tenerife
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San Cristóbal de La Laguna, Santa Cruz de Tenerife, Spanien, 38201
- Clínica Avanza Salud
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Kontakt:
- Eduardo Luis Martín Javier
- Telefonnummer: +34 647 773 675
- E-Mail: eduardo@avanza-salud.com
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
Einschlusskriterien:
- Alter 18 Jahre und älter.
- Diagnose von Typ-1- oder Typ-2-Diabetes mellitus.
- Fähigkeit, die Einwilligung nach Aufklärung zu verstehen und zu unterschreiben.
Ausschlusskriterien:
- Aktive Fußulzera.
- Kürzliche Operation an den unteren Gliedmaßen.
- Kognitive Beeinträchtigung, die die Einhaltung des Studienprotokolls verhindert.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
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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.
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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.
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.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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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
Zeitfenster: Single measurement session (Day 1)
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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.
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Single measurement session (Day 1)
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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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
Zeitfenster: Single measurement session (Day 1)
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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.
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Single measurement session (Day 1)
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Consistency intraclass correlation coefficient, ICC(C,1), between the two cameras for mean plantar temperature (Tmean)
Zeitfenster: Single measurement session (Day 1)
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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.
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Single measurement session (Day 1)
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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)
Zeitfenster: Single measurement session (Day 1)
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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.
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Single measurement session (Day 1)
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Influence of participant clinical variables on the magnitude of inter-device discordance
Zeitfenster: Single measurement session (Day 1)
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The absolute inter-device difference is analyzed against the presence of peripheral sensory neuropathy, body mass index and type of diabetes mellitus.
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Single measurement session (Day 1)
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Image acquisition time
Zeitfenster: Single measurement session (Day 1)
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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.
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Single measurement session (Day 1)
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Proportion of technically valid thermograms
Zeitfenster: Single measurement session (Day 1)
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Percentage of thermographic acquisitions that did not require repetition because of a technical error, namely defocus, participant movement or a saving failure.
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Single measurement session (Day 1)
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Participant acceptability of the measurement protocol
Zeitfenster: Single measurement session (Day 1)
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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.
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Single measurement session (Day 1)
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Descriptive distribution of the maximum contralateral thermal asymmetry per participant
Zeitfenster: Single measurement session (Day 1)
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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.
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Single measurement session (Day 1)
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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- HIK-DM-2026-01
- CHUC_2026_24 (Andere Kennung: CEIm Provincial de Santa Cruz de Tenerife, Complejo Hospitalario Universitario de Canarias)
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