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Patient Specific 3D Printed Diabetic Insoles to Reduce Plantar Pressure

NCT05301478 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-04-20

No results posted yet for this study

Summary

In this research study, the investigators are evaluating if novel custom foot orthotics improves foot health and mobility for people who are at increased risk of developing foot ulcers. The investigators are comparing different methods of custom foot orthotic fabrication in people who are at increased risk of developing foot ulcers and individuals who are not. Participating in this study involves coming to the VA Hospital in Seattle for up to 12 study visits, lasting up to four hours. If eligible and choose to participate, participants will:

* Wear custom foot orthotics during in laboratory testing for up to four hours
* Receive a foot health assessment
* Walk through the laboratory space so the investigators can see how the orthotics affect the participant's body movement
* Participants will be paid for participating in the study

Conditions

Interventions

DEVICE

standard of care insole

standard of care diabetic insole

DEVICE

3D Printed Insole - pressure based

3D Printed Insole - pressure based

DEVICE

3D Printed Insole - FEA

3D Printed Insole - FEA

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Brittney C Muir, PhD · VA Puget Sound Health Care System Seattle Division, Seattle, WA

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2025-03-30
Completion
2026-03-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05301478 on ClinicalTrials.gov