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

NACompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

November 11, 2024

Primary Completion Date

December 10, 2024

Study Completion Date

December 10, 2024

Conditions
Diabetes Mellitus
Interventions
DEVICE

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."

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.

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.

Trial Locations (1)

11368

TeamOlmed Hagaplan, Stockholm

All Listed Sponsors
lead

Vastra Gotaland Region

OTHER_GOV

NCT06679192 - Thickness-Varied Soft Surface on Shoe-Insoles Based on In-Shoe Pressure Measurement | Biotech Hunter | Biotech Hunter