Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2025-12-24 @ 3:35 PM
Study NCT ID:
NCT06679192
Status:
COMPLETED
Last Update Posted:
2025-03-26
First Post:
2024-11-04
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Thickness-Varied Soft Surface on Shoe-Insoles Based on In-Shoe Pressure Measurement
Sponsor:
Vastra Gotaland Region
Organization:
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: