An interventional study of felt padding in Diabetic Complications and Foot Care, sponsored by University of Valencia. Recruiting at 1 site in Spain. Open to participants aged 55 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-02.
Sponsored by University of Valencia · Not applicable, Interventional, and Prevention
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.
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.
267 studies on the registry are indexed under Diabetes Complications; 54 are open to participants now.
This study's planned enrollment of 46 is below the median of 72 across 171 interventional studies indexed under Diabetes Complications.
Browse Diabetes Complications studies →University of Valencia is the lead sponsor of 357 studies on the registry; 75 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The 5 mm and 10 mm felt pads are applied for 4 days.
Other: felt padding
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.
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
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
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
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
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
Tissue wáter index (TWI)
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
Tissue lipid index (TLI)
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
Mean pressure (Pmean)
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.
Time frame: Baseline and 4 days
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2021 (actual). Primary completion is estimated for Jan 2027, 69 months after the start.
Of 62 non-industry interventional studies with no phase under Diabetes Complications, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 41. This study's planned 69 months is above that.
Counting every sponsor, half of 69 studies reached it within 28 months; a quarter within 12 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
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