Evaluation of Materials for the Distribution of Pressure in the Treatment of Neuroischemic Ulcers
The hypothesis of this study is based on the premise that pressure-distributing materials with superior biomechanical and tissue response properties will be capable of improving the healing rate of neuropathic ulcers.
The overarching objective of the present project is to assess the influence of the nature and method of application of the materials under study on tissue response, the reduction of pressure on the sole of the foot, and the healing of neuropathic ulcers in patients with diabetes mellitus.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
The study is divided into two distinct phases:
The following analysis is concerned with the characteristics of materials that are employed for the purpose of the distribution of pressure. This will entail the meticulous analysis of the response exhibited by the materials, with the objective of ascertaining their true biomechanical behaviour in volunteers devoid of active ulcers.
The materials selected in the first part will be applied for the treatment of revascularised neuroischaemic ulcers. This will determine which of the materials is the most suitable for treating the lesion.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: IVAN JULIAN ROCHINA, PhD
- Telefoonnummer: +34 639687251
- E-mail: ivan.julian@uv.es
Studie Locaties
-
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Valencia
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Valencia, Valencia, Spanje
- Werving
- Hospital Universitario y Politécnico La Fe
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Contact:
- IVAN JULIAN ROCHINA
- Telefoonnummer: +34639687251
- E-mail: ivan.julian@uv.es
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
- Aged between 55 and 75.
- Diagnosis of diabetes mellitus.
- Patients with an ankle-brachial index of >0.8 and <1.2.
- Signature of the informed consent form
Exclusion Criteria:
- Leg or foot injuries or ulcers that cause pain and prevent normal movement in both lower limbs.
- Foot trauma within the last month.
- Inability to adhere to the full schedule of measurements required by the study.
- Participants who do not sign the informed consent form.
- Known contact dermatitis to any of the study materials
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: felt padding
The 5 mm and 10 mm felt pads are applied for 4 days.
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The 5 mm felt pad is applied for 4 days and then removed.
After allowing the skin at least 48 hours to recover, the 10 mm felt pad is applied, also for 4 days.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Near-infrared perfusion index (NIR perfusion)
Tijdsspanne: Baseline and 4 days
|
Hyperspectral imaging was performed using the TIVITA® 2.0 camera (Diaspective Vision GmbH, Germany).
This non-contact, non-invasive device captures images across multiple wavelengths within the visible and near-infrared spectrum (500-1000 nm), enabling assessment of microcirculatory parameters up to a tissue depth of approximately 8 mm.
The device provides an image resolution of 640 × 480 pixels, with an acquisition time of 6.4 seconds.
Images were analyzed using TIVITA® Suite software by selecting a circular region of interest adjusted to the metatarsal head and offloading area under study.
|
Baseline and 4 days
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Thermography
Tijdsspanne: Baseline and 4 days
|
The images will be captured using the FLIR C8 thermal imaging camera.
The camera in question features a true thermal resolution of 320 × 240 pixels (76,800 measurement points) and MSX® technology, which combines visual and thermal details into a single image, thereby facilitating the detection of anatomical abnormalities.
Thermographic variables of interest included differences in absolute temperature values (maximum and mean temperature) within the region of interest corresponding to the offloading area.
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Baseline and 4 days
|
|
Peak pressure (Pmax)
Tijdsspanne: Baseline and 4 days
|
Peak pressure (Pmax) measured at the metatarsal head corresponding to the highest dynamic pressure. Plantar pressures were assessed using the EPS+R platform (Loran Engineering®, Bologna, Italy). The platform measures 50 × 70 × 4 mm, weighs 7 kg, and incorporates 2304 resistive sensors measuring 9 × 9 mm each. The pressure range is 50-350 kPa, with a maximum acquisition frequency of 100 Hz. Biomech® Studio 2019 software (LetSense Srl, Loran Engineering®) was used for data analysis. |
Baseline and 4 days
|
|
Tissue oxygen saturation (StO₂)
Tijdsspanne: Baseline and 4 days
|
Hyperspectral imaging was performed using the TIVITA® 2.0 camera (Diaspective Vision GmbH, Germany).
This non-contact, non-invasive device captures images across multiple wavelengths within the visible and near-infrared spectrum (500-1000 nm), enabling assessment of microcirculatory parameters up to a tissue depth of approximately 8 mm.
The device provides an image resolution of 640 × 480 pixels, with an acquisition time of 6.4 seconds.
Images were analyzed using TIVITA® Suite software by selecting a circular region of interest adjusted to the metatarsal head and offloading area under study.
|
Baseline and 4 days
|
|
Tissue hemoglobin index (THI)
Tijdsspanne: Baseline and 4 days
|
Hyperspectral imaging was performed using the TIVITA® 2.0 camera (Diaspective Vision GmbH, Germany).
This non-contact, non-invasive device captures images across multiple wavelengths within the visible and near-infrared spectrum (500-1000 nm), enabling assessment of microcirculatory parameters up to a tissue depth of approximately 8 mm.
The device provides an image resolution of 640 × 480 pixels, with an acquisition time of 6.4 seconds.
Images were analyzed using TIVITA® Suite software by selecting a circular region of interest adjusted to the metatarsal head and offloading area under study.
|
Baseline and 4 days
|
|
Tissue wáter index (TWI)
Tijdsspanne: Baseline and 4 days
|
Hyperspectral imaging was performed using the TIVITA® 2.0 camera (Diaspective Vision GmbH, Germany).
This non-contact, non-invasive device captures images across multiple wavelengths within the visible and near-infrared spectrum (500-1000 nm), enabling assessment of microcirculatory parameters up to a tissue depth of approximately 8 mm.
The device provides an image resolution of 640 × 480 pixels, with an acquisition time of 6.4 seconds.
Images were analyzed using TIVITA® Suite software by selecting a circular region of interest adjusted to the metatarsal head and offloading area under study.
|
Baseline and 4 days
|
|
Tissue lipid index (TLI)
Tijdsspanne: Baseline and 4 days
|
Hyperspectral imaging was performed using the TIVITA® 2.0 camera (Diaspective Vision GmbH, Germany).
This non-contact, non-invasive device captures images across multiple wavelengths within the visible and near-infrared spectrum (500-1000 nm), enabling assessment of microcirculatory parameters up to a tissue depth of approximately 8 mm.
The device provides an image resolution of 640 × 480 pixels, with an acquisition time of 6.4 seconds.
Images were analyzed using TIVITA® Suite software by selecting a circular region of interest adjusted to the metatarsal head and offloading area under study.
|
Baseline and 4 days
|
|
Mean pressure (Pmean)
Tijdsspanne: Baseline and 4 days
|
Mean pressure (Pmean) measured at the metatarsal head corresponding to the highest dynamic pressure. Plantar pressures were assessed using the EPS+R platform (Loran Engineering®, Bologna, Italy). The platform measures 50 × 70 × 4 mm, weighs 7 kg, and incorporates 2304 resistive sensors measuring 9 × 9 mm each. The pressure range is 50-350 kPa, with a maximum acquisition frequency of 100 Hz. Biomech® Studio 2019 software (LetSense Srl, Loran Engineering®) was used for data analysis. |
Baseline and 4 days
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2020-672-1
Plan Individuele Deelnemersgegevens (IPD)
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Informatie over medicijnen en apparaten, studiedocumenten
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