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NCT Number: NCT07620379

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.

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Key information

Age range

55 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario y Politécnico La Fe

Valencia, Spain

Location status: Recruiting

Location contact

IVAN JULIAN ROCHINA

CONTACT

[email protected]

+34639687251

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

felt padding

Other

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.

Primary outcomes

  1. Near-infrared perfusion index (NIR perfusion)

    Time frame: 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.

Secondary outcomes

  1. Thermography

    Time frame: 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.

  2. Peak pressure (Pmax)

    Time frame: 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.

  3. Tissue oxygen saturation (StO₂)

    Time frame: 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.

  4. Tissue hemoglobin index (THI)

    Time frame: 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.

  5. Tissue wáter index (TWI)

    Time frame: 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.

  6. Tissue lipid index (TLI)

    Time frame: 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.

  7. Mean pressure (Pmean)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

IVAN JULIAN ROCHINA, PhD

CONTACT

[email protected]

+34 639687251

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Collaborators

  • Instituto de Investigacion Sanitaria La Fe

Registry information

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Jun 2, 2026
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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