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

NCT06679192 | Completed

• 1 other identifier: 2024-02115-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

plantar pressure; shoe insert; ulcer prevention

Outcome Measures

Primary Outcomes (1)

• Plantar pressure

  Measured plantar pressure (kPa) differences between the arms/interventions.

  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.

Study Arms (3)

Thickness-Varied soft surface insole

EXPERIMENTAL

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

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.

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.

Device: No soft upper surface

Interventions

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

Thickness-Varied soft surface insole

3mm soft upper surface 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.

3mm soft surface insole

No soft upper surface 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.

No soft surface insole

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Study Sites (1)

TeamOlmed Hagaplan

Stockholm, 11368, Sweden

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Roy Tranberg, PhD, Docent

  Vastra Gotaland Region

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: three-intervention cross over study.

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 7, 2024
• Study Start: November 11, 2024
• Primary Completion: December 10, 2024
• Study Completion: December 10, 2024
• Last Updated: March 26, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)