Evaluation of Materials for the Distribution of Pressure in the Treatment of Neuroischemic Ulcers

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55-75
SponsorUniversity of Valencia

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • felt padding

    Other intervention

    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.

Treatment groups

46 Participants
are divided into 1 treatment group
Group A: felt paddingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Near-infrared perfusion index (NIR perfusion)

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.

Time frame
Baseline and 4 days

Secondary outcomes

1

Thermography

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.

Time frame
Baseline and 4 days
2

Peak pressure (Pmax)

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.

Time frame
Baseline and 4 days
3

Tissue oxygen saturation (StO₂)

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.

Time frame
Baseline and 4 days
4

Tissue hemoglobin index (THI)

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.

Time frame
Baseline and 4 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Valencia

Lead sponsor

Instituto de Investigacion Sanitaria La Fe

Collaborator