Thickness-Varied Soft Surface on Shoe-Insoles Based on In-Shoe Pressure Measurement

NCT ID: NCT06679192

Last Updated: 2025-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-11
• Study Completion Date: 2024-12-10

Brief 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. 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.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Thickness-Varied soft surface insole

Each participant will be measured with this insole. The order between the three insoles is randomized.

Group Type: EXPERIMENTAL

Milled thickness varied soft upper surface, based on plantar pressure measurement

Intervention Type: DEVICE

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 surface insole

Each participant will be measured with this insole. The order between the three insoles is randomized.

Group Type: EXPERIMENTAL

3mm soft upper surface

Intervention Type: DEVICE

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 surface insole

Each participant will be measured with this insole. The order between the three insoles is randomized.

Group Type: EXPERIMENTAL

No soft upper surface

Intervention Type: DEVICE

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.

Interventions

Milled thickness varied soft upper surface, based on plantar pressure measurement

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.

Intervention Type: DEVICE

3mm soft upper surface

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.

Intervention Type: DEVICE

No soft upper surface

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vastra Gotaland Region

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roy Tranberg, PhD, Docent

Role: PRINCIPAL_INVESTIGATOR

Vastra Gotaland Region

Locations

TeamOlmed Hagaplan

Stockholm, , Sweden

Countries

Sweden

Other Identifiers

2024-02115-01

Identifier Type: -

Identifier Source: org_study_id