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

Not Applicable

Completed

• Conditions: Diabetes Mellitus

• Registration Number: NCT06679192
• Lead Sponsor: Vastra Gotaland Region

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-04
• Study First Submitted QC: 2024-11-05
• Study First Posted: 2024-11-07
• Study Start: 2024-11-11
• Primary Completion: 2024-12-10
• Study Completion: 2024-12-10
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Plantar pressure	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.

Trial Locations

Locations (1)

TeamOlmed Hagaplan; 🇸🇪 Stockholm, Sweden