Diabetes MellitusNCT06679192
Thickness-Varied Soft Surface on Shoe-Insoles Based on In-Shoe Pressure Measurement
A study testing Milled thickness varied soft upper surface, based on plantar pressure measurement, 3mm soft upper surface and No soft upper surface in people with Diabetes Mellitus, run by Vastra Gotaland Region at 1 site in Sweden.
Trial summary
The goal of this cross-sectional study is to evaluate a new shoe insole manufacturing method with the goal of further preventing foot ulceration for people with diabetes. This is achieved by decreasing pressure under risk areas of the foot, often on the insole; the interface between the shoe and the foot. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Milled thickness varied soft upper surface, based on plantar pressure measurement, 3mm soft upper surface and No soft upper surface
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- 11 Nov 2024to 10 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years of age at the date of signing consent.
- Diabetes mellitus 1 or 2
- Diabetic foot risk group 2: Signs of distal neuropathy and/or peripheral circulatory disorder.
- Able to walk 10 meters without walking aids
- Able to speak and understand Swedish
Who cannot join
- Diabetic foot risk group 3: Distal neuropathy or peripheral circulatory disorder and foot ulcers, or amputation, foot deformity of clinical importance or skin pathology.
- Diabetic foot risk group 4: Occuring foot ulcer, severe osteoarthropathy or chronic foot pain.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing a Thickness-Varied Soft Surface of Custom Made Shoe Insoles Based on Plantar Pressure Analysis in Shoes, to Insoles With Even Thickness Surfaces: A Cross Sectional Study Design
The goal of this cross-sectional study is to evaluate a new shoe insole manufacturing method with the goal of further preventing foot ulceration for people with diabetes. This is achieved by decreasing pressure under risk areas of the foot, often on the insole; the interface between the shoe and the foot. The main question it aims to answer is:
Does a thickness-varied surface based on plantar pressure measurement decrease pressure at high risk areas compared to even thickness surfaces.
Read more
Researchers will compare three different pairs of insoles for each participant.
Participants will partake in two sessions. The first one being a pre-measurement and foot status for manufacturing the insoles. During the second session, three pairs of insoles will in a random order be tested for each participant. The pressure measurement of the insoles will be made using F-Scan(TM), while participants walk.
- Conditions
- Diabetes Mellitus
- Being tested
- Milled thickness varied soft upper surface, based on plantar pressure measurement, 3mm soft upper surface, No soft upper surface
- Keywords
- plantar pressure, shoe insert, ulcer prevention
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Milled thickness varied soft upper surface, based on plantar pressure measurementDevice
This custom made shoe insole is milled, with a thickness varied soft upper surface ranging from 0-6mm in thickness. The base of the insole is 45 shore Ethylene-vinyl acetate (EVA).
This intervention makes the insole from an individual foot scan, a plantar pressure measurement from the individual and the shoe model to mill a finished custom made shoe insole with a soft upper surface. It is difficult in clinical practice of making shoe inserts to create a thickness varied soft upper with different zones all over the insole. Furthermore, a soft upper requires a physical positive model to be made of the foot and staff must spend time to grind the insole to an acceptable shape. A milled version would be more effective since it require no physical foot model, little to no work grinding the insole and enables the use of thickness-variations. It also enables the use of data-based insole-manufacturing, such as data from plantar pressure measurements.
3mm soft upper surfaceDevice
This intervention has a 3mm soft layer on the insole, milled with a 45 shore base of the custom made insole. This is one of the most commonly used designs in clinical practice.
No soft upper surfaceDevice
This intervention has a no soft layer on the insole, milled with a 45 shore base of the custom made insole. This is one of the most commonly used designs in clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Thickness-Varied soft surface insole | Experimental | Each participant will be measured with this insole. The order between the three insoles is randomized. Receives: Device: Milled thickness varied soft upper surface, based on plantar pressure measurement |
| 3mm soft surface insole | Experimental | Each participant will be measured with this insole. The order between the three insoles is randomized. Receives: Device: 3mm soft upper surface |
| No soft surface insole | Experimental | Each participant will be measured with this insole. The order between the three insoles is randomized. Receives: Device: No soft upper surface |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plantar pressure
Measured plantar pressure (kPa) differences between the arms/interventions.
Measured: Pre-measurement used for insole design at first meeting. Intervention-measurement for all patients and interventions at second meeting, approximately 3-4 weeks after pre-measurement.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start11 Nov 2024
- Primary completion10 Dec 2024
- Study completion10 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe 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
- Randomised
- Intervention model
- Crossover
- Model description
- three-intervention cross over study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Roy Tranberg, PhD, Docent, Principal investigator, Vastra Gotaland Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06679192
- Sponsor's protocol ID
- 2024-02115-01
- Status last verified
- Nov 2024
- First submitted
- 4 Nov 2024
- Last updated
- 26 Mar 2025
- 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 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing a Thickness-Varied Soft Surface of Custom Made Shoe Insoles Based on Plantar Pressure Analysis in Shoes, to Insoles With Even Thickness Surfaces: A Cross Sectional Study Design
- ClinicalTrials.gov ID
- NCT06679192
- Acronym / sponsor ID
- 2024-02115-01
- Conditions
- Diabetes Mellitus
- Keywords
- plantar pressure, shoe insert, ulcer prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- 10 Dec 2024 (actual)
- Study completion
- 10 Dec 2024 (actual)
- First posted
- 7 Nov 2024 (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 goal of this cross-sectional study is to evaluate a new shoe insole manufacturing method with the goal of further preventing foot ulceration for people with diabetes. This is achieved by decreasing pressure under risk areas of the foot, often on the insole; the interface between the shoe and the foot. The main question it aims to answer is:
Does a thickness-varied surface based on plantar pressure measurement decrease pressure at high risk areas compared to even thickness surfaces.
Researchers will compare three different pairs of insoles for each participant.
Participants will partake in two sessions. The first one being a pre-measurement and foot status for manufacturing the insoles. During the second session, three pairs of insoles will in a random order be tested for each participant. The pressure measurement of the insoles will be made using F-Scan(TM), while participants walk.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- three-intervention cross over study.
| Arm | Type | Receives |
|---|---|---|
| Thickness-Varied soft surface insole | Experimental | Device: Milled thickness varied soft upper surface, based on plantar pressure measurementEach participant will be measured with this insole. The order between the three insoles is randomized. |
| 3mm soft surface insole | Experimental | Device: 3mm soft upper surfaceEach participant will be measured with this insole. The order between the three insoles is randomized. |
| No soft surface insole | Experimental | Device: No soft upper surfaceEach participant will be measured with this insole. The order between the three insoles is randomized. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Over 18 years of age at the date of signing consent.
- Diabetes mellitus 1 or 2
- Diabetic foot risk group 2: Signs of distal neuropathy and/or peripheral circulatory disorder.
- Able to walk 10 meters without walking aids
- Able to speak and understand Swedish
Key exclusion criteria (2 listed)
- Diabetic foot risk group 3: Distal neuropathy or peripheral circulatory disorder and foot ulcers, or amputation, foot deformity of clinical importance or skin pathology.
- Diabetic foot risk group 4: Occuring foot ulcer, severe osteoarthropathy or chronic foot pain.
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 |
|---|---|---|
| Milled thickness varied soft upper surface, based on plantar pressure measurementThis custom made shoe insole is milled, with a thickness varied soft upper surface ranging from 0-6mm in thickness. The base of the insole is 45 shore Ethylene-vinyl acetate (EVA). This intervention makes the insole from an individual foot scan, a plantar pressure measurement from the individual and the shoe model to mill a finished custom made shoe insole with a soft upper surface. It is difficult in clinical practice of making shoe inserts to create a thickness varied soft upper with different zones all over the insole. Furthermore, a soft upper requires a physical positive model to be made of the foot and staff must spend time to grind the insole to an acceptable shape. A milled version would be more effective since it require no physical foot model, little to no work grinding the insole and enables the use of thickness-variations. It also enables the use of data-based insole-manufacturing, such as data from plantar pressure measurements. | Device | Thickness-Varied soft surface insole |
| 3mm soft upper surfaceThis intervention has a 3mm soft layer on the insole, milled with a 45 shore base of the custom made insole. This is one of the most commonly used designs in clinical practice. | Device | 3mm soft surface insole |
| No soft upper surfaceThis intervention has a no soft layer on the insole, milled with a 45 shore base of the custom made insole. This is one of the most commonly used designs in clinical practice. | Device | No soft surface insole |
Primary outcome
Plantar pressure
Time frame: Pre-measurement used for insole design at first meeting. Intervention-measurement for all patients and interventions at second meeting, approximately 3-4 weeks after pre-measurement.
Measured plantar pressure (kPa) differences between the arms/interventions.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- 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. This study is not recruiting at the moment.
Roy Tranberg, PhD, Docent principal investigator
Vastra Gotaland Region
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Milled thickness varied soft upper surface, based on plantar pressure measurement, 3mm soft upper surface and No soft upper surface in people with Diabetes Mellitus, run by Vastra Gotaland Region at 1 site in Sweden.
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 5 inclusion and 2 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: finished, as of the sponsor's last update on 26 Mar 2025. 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 Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (time frame: Pre-measurement used for insole design at first meeting. Intervention-measurement for all patients and interventions at second meeting, approximately 3-4 weeks after pre-measurement.). 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 26 Mar 2025.