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

Vastra Gotaland Region

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Device: Milled thickness varied soft upper surface, based on plantar pressure measurement; Device: No soft upper surface; Device: 3mm soft upper surface

Study type: Interventional

Funder types: Other

Identifiers

NCT06679192

2024-02115-01

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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30 participants in 3 patient groups

Thickness-Varied soft surface insole

Experimental group

Description:

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

Treatment:

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

3mm soft surface insole

Experimental group

Description:

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

Treatment:

Device: 3mm soft upper surface

No soft surface insole

Experimental group

Description:

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

Treatment:

Device: No soft upper surface