Diabetic ComplicationsNCT07620379
Evaluation of Materials for the Distribution of Pressure in the Treatment of Neuroischemic Ulcers
A study testing felt padding in people with Diabetic Complications and Foot Care, run by University of Valencia at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 55 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Complications, Foot Care
- What is being tested?
- felt padding
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteSpain
- Study dates
- 9 Mar 2021to 8 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario y Politécnico La Fe
Valencia, Valencia
IVAN JULIAN ROCHINA, +34639687251, ivan.julian@uv.es
About this study
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.
Read the detailed description
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.
- Conditions
- Diabetic Complications, Foot Care
- Being tested
- felt padding
- Keywords
- diabetic foot, plantar pressure, offloading, felt padding, hyperspectral imaging, thermography, pressure redistribution, ulcer prevention
- Medical subject headings
- Diabetes Complications, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
felt paddingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| felt padding | Experimental | The 5 mm and 10 mm felt pads are applied for 4 days. Receives: Other: felt padding |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 4 days
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start9 Mar 2021
- Primary completion1 Jan 2027 (estimated)
- Study completion8 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic ComplicationsStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Investigacion Sanitaria La Fe
- Responsible party
- Principal investigator, Iván Julián Rochina, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07620379
- Sponsor's protocol ID
- 2020-672-1
- Status last verified
- May 2026
- First submitted
- 13 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Materials for the Distribution of Pressure in the Treatment of Neuroischemic Ulcers
- ClinicalTrials.gov ID
- NCT07620379
- Acronym / sponsor ID
- 2020-672-1
- Conditions
- Diabetic Complications, Foot Care
- Keywords
- diabetic foot, plantar pressure, offloading, felt padding, hyperspectral imaging, thermography, pressure redistribution, ulcer prevention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Collaborators
- Instituto de Investigacion Sanitaria La Fe
- Study start
- 9 Mar 2021 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 8 Mar 2027 (estimated)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| felt padding | Experimental | Other: felt paddingThe 5 mm and 10 mm felt pads are applied for 4 days. |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| felt paddingThe 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. | Other | felt padding |
Primary outcome
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.
7 secondary outcomes
Thermography
Time frame: Baseline and 4 days
Peak pressure (Pmax)
Time frame: Baseline and 4 days
Tissue oxygen saturation (StO₂)
Time frame: Baseline and 4 days
Tissue hemoglobin index (THI)
Time frame: Baseline and 4 days
Tissue wáter index (TWI)
Time frame: Baseline and 4 days
Tissue lipid index (TLI)
Time frame: Baseline and 4 days
Mean pressure (Pmean)
Time frame: Baseline and 4 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing felt padding in people with Diabetic Complications and Foot Care, run by University of Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact IVAN JULIAN ROCHINA, PhD (+34 639687251, ivan.julian@uv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Near-infrared perfusion index (NIR perfusion) (time frame: Baseline and 4 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.