Diabete MellitusSiliconepadsNCT07172763
The Pressure Relieving Capacity of Siliconepads Compared to Felted Foam to Relieve Caput Metatarsal 2 in a Population With Diabetes
An observational study of Diabete Mellitus and Peripheral Neuropathy, run by University Hospital, Ghent.
Trial summary
To evaluate the clinical effectiveness of siliconepads and if they could be an alternative to felted foam used in offloading high risk pressure areas in the plantar forefoot region using plantar pressure measurements. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diabete Mellitus, Peripheral Neuropathy
- What is being tested?
- Siliconepad and Felted foam
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 8 Oct 2025to 30 Oct 2028
- How long will I take part?
- 1 Week
- Phase
- Observational
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diabetic patients with peripheral neuropathy
Who may be able to join
- Diabetes, Peripheral neuropathy, able to walk 5 minutes, able to sign informed consent
Who cannot join
- No diabetes, No neuropathy, not able to walk without walking aid, not able to sign informed consent
About this study
Official title: The Pressure Relieving Capacity of Siliconepads Compared to Felted Foam to Relieve Caput Metatarsal 2 in a Population With Diabetes at High Risk of Foot Ulcerations
To evaluate the clinical effectiveness of siliconepads and if they could be an alternative to felted foam used in offloading high risk pressure areas in the plantar forefoot region using plantar pressure measurements.
Also user experience will be evaluated which is an important criterion in the use of this new type of offloading. Comfort, convenience and functionality of both felted foam and siliconepads will be tested to evaluate if siliconepads are more appropriate then felted foam.
Read the detailed description
People with diabetes mellitus (DM) experience increased pressure under the plantar surface of the foot because of morphological, muscular and sensory abnormalities.
One third of these people have deformed feet, usually due to diabetic neuropathy, which causes localized increases in plantar pressure, particularly on the plantar side of the forefoot, where the risk of foot ulcers is high.
Custom-made therapeutic shoes and arch supports are recommended and are part of standard care for patients with foot deformities and a history of ulceration. The pressure under a human foot can be measured using a technique called Pedobarography or plantar pressure measurement, which uses insole- or platform-based pressure and force systems.
Pedobarographic measurements quantify the vertical load experienced by the foot when walking barefoot or with footwear by measuring the pressure on the plantar side. This makes it possible to identify any functional abnormalities in the structure and function of the dynamic foot. Wearing shoes with or without arch supports was reported to reduce peak pressure by 17 to 52% compared to walking barefoot. Furthermore, proof-of-principle studies have shown that reducing peak pressure on the plantar surface to less than 200 kPa (or by at least 25%) halves the risk of ulcer recurrence in people with diabetes over an 18-month period.
Felted foam therapy is, in addition to insoles and shoes, a complementary conservative treatment that facilitates this pressure relief. Felt consists of compressed wool in various thicknesses that distributes the increased pressure over a larger surface area, thereby reducing the peak pressure at a specific point. The location of the peak pressure is then relieved by the felt with a recess at this zone, whereby the pressure is distributed over the surface.
Felted foam, which has been the 3rd offloading method when it comes to local pressure relief after removable and non-removable knee-high devices, has many advantages but also its limitations. The material needs to be replaced weekly but in reality is often replaced every two days because the effect of the felt is limited in time. The thickness of the original felt decreases with wear and the material must not get wet.
Siliconepads, specifically designed for this study (Remedicare, Netherlands), with a CE certificate, could be more resistant than felt and a game changer in the offloading around the ulcer. These siliconepads are now used in treatment of skin tears and adapted for this study so this can be used and applied similarly to felted foam.
- Conditions
- Diabete Mellitus, Peripheral Neuropathy
- Being tested
- Siliconepad, Felted foam
- Keywords
- Diabetes, Sensory peripheral neuropathy, Siliconepads, Felted foam, Plantar pressure measurement
- Medical subject headings
- Diabetes Mellitus, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SiliconepadDevice
Plantar pressure measurement
Felted foamDevice
Plantar pressure measurement
What is being measured
The primary outcome is the main question the study is designed to answer.
Plantar pressure reduction
Achieve a plantar pressure decrease of 25%, leading to less than 200kpa under the 2nd caput metatarsal region after wearing siliconepads in comparison to barefoot plantar pressure measurement at baseline and after 48 hours.
Achieve a plantar pressure decrease of 25% or less then 200kpa in the 2nd caput metatarsal region after wearing felted foam in comparison to barefoot plantar pressure measurement at baseline and after 48 hours.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start8 Oct 2025 (estimated)
- Primary completion30 Mar 2028 (estimated)
- Study completion30 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete MellitusStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DienstThoracaleEnVasculaireHeelkunde, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07172763
- Sponsor's protocol ID
- ONZ-2024-0628
- Acronym
- Siliconepads
- Status last verified
- Sep 2025
- First submitted
- 8 Sep 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pressure Relieving Capacity of Siliconepads Compared to Felted Foam to Relieve Caput Metatarsal 2 in a Population With Diabetes at High Risk of Foot Ulcerations
- ClinicalTrials.gov ID
- NCT07172763
- Acronym / sponsor ID
- Siliconepads / ONZ-2024-0628
- Conditions
- Diabete Mellitus, Peripheral Neuropathy
- Keywords
- Diabetes, Sensory peripheral neuropathy, Siliconepads, Felted foam, Plantar pressure measurement
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 8 Oct 2025 (estimated)
- Primary completion
- 30 Mar 2028 (estimated)
- Study completion
- 30 Oct 2028 (estimated)
- First posted
- 15 Sep 2025 (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.
To evaluate the clinical effectiveness of siliconepads and if they could be an alternative to felted foam used in offloading high risk pressure areas in the plantar forefoot region using plantar pressure measurements.
Also user experience will be evaluated which is an important criterion in the use of this new type of offloading. Comfort, convenience and functionality of both felted foam and siliconepads will be tested to evaluate if siliconepads are more appropriate then felted foam.
Detailed description
People with diabetes mellitus (DM) experience increased pressure under the plantar surface of the foot because of morphological, muscular and sensory abnormalities.
One third of these people have deformed feet, usually due to diabetic neuropathy, which causes localized increases in plantar pressure, particularly on the plantar side of the forefoot, where the risk of foot ulcers is high.
Custom-made therapeutic shoes and arch supports are recommended and are part of standard care for patients with foot deformities and a history of ulceration. The pressure under a human foot can be measured using a technique called Pedobarography or plantar pressure measurement, which uses insole- or platform-based pressure and force systems.
Pedobarographic measurements quantify the vertical load experienced by the foot when walking barefoot or with footwear by measuring the pressure on the plantar side. This makes it possible to identify any functional abnormalities in the structure and function of the dynamic foot. Wearing shoes with or without arch supports was reported to reduce peak pressure by 17 to 52% compared to walking barefoot. Furthermore, proof-of-principle studies have shown that reducing peak pressure on the plantar surface to less than 200 kPa (or by at least 25%) halves the risk of ulcer recurrence in people with diabetes over an 18-month period.
Felted foam therapy is, in addition to insoles and shoes, a complementary conservative treatment that facilitates this pressure relief. Felt consists of compressed wool in various thicknesses that distributes the increased pressure over a larger surface area, thereby reducing the peak pressure at a specific point. The location of the peak pressure is then relieved by the felt with a recess at this zone, whereby the pressure is distributed over the surface.
Felted foam, which has been the 3rd offloading method when it comes to local pressure relief after removable and non-removable knee-high devices, has many advantages but also its limitations. The material needs to be replaced weekly but in reality is often replaced every two days because the effect of the felt is limited in time. The thickness of the original felt decreases with wear and the material must not get wet.
Siliconepads, specifically designed for this study (Remedicare, Netherlands), with a CE certificate, could be more resistant than felt and a game changer in the offloading around the ulcer. These siliconepads are now used in treatment of skin tears and adapted for this study so this can be used and applied similarly to felted foam.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Week
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetic patients with peripheral neuropathy
Key inclusion criteria (1 listed)
- Diabetes, Peripheral neuropathy, able to walk 5 minutes, able to sign informed consent
Key exclusion criteria (1 listed)
- No diabetes, No neuropathy, not able to walk without walking aid, not able to sign informed consent
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 |
|---|---|---|
| SiliconepadPlantar pressure measurement | Device | – |
| Felted foamPlantar pressure measurement | Device | – |
Primary outcome
Plantar pressure reduction
Time frame: 48 hours
Achieve a plantar pressure decrease of 25%, leading to less than 200kpa under the 2nd caput metatarsal region after wearing siliconepads in comparison to barefoot plantar pressure measurement at baseline and after 48 hours. Achieve a plantar pressure decrease of 25% or less then 200kpa in the 2nd caput metatarsal region after wearing felted foam in comparison to barefoot plantar pressure measurement at baseline and after 48 hours.
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 22 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabete Mellitus and Peripheral Neuropathy, run by University Hospital, Ghent.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plantar pressure reduction (time frame: 48 hours). 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 22 Sep 2025.