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

March 25, 2025 updated by: Vastra Gotaland Region

Comparing a Thickness-Varied Soft Surface of Custom Made Shoe Insoles Based on Plantar Pressure Analysis in Shoes, to Insoles With Even Thickness Surfaces: A Cross Sectional Study Design

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 11368
        • TeamOlmed Hagaplan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Thickness-Varied soft surface insole
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

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.
Experimental: 3mm soft surface insole
Each participant will be measured with this insole. The order between the three insoles is randomized.
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.
Experimental: No soft surface insole
Each participant will be measured with this insole. The order between the three insoles is randomized.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plantar pressure
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vastra Gotaland Region

Investigators

  • Principal Investigator: Roy Tranberg, PhD, Docent, Vastra Gotaland Region

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2024

Primary Completion (Actual)

December 10, 2024

Study Completion (Actual)

December 10, 2024

Study Registration Dates

First Submitted

November 4, 2024

First Submitted That Met QC Criteria

November 5, 2024

First Posted (Actual)

November 7, 2024

Study Record Updates

Last Update Posted (Estimated)

March 26, 2025

Last Update Submitted That Met QC Criteria

March 25, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-02115-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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