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ACTIVE NOT RECRUITING
NCT05301478
NA

Patient Specific 3D Printed Diabetic Insoles to Reduce Plantar Pressure

Sponsor: VA Office of Research and Development

View on ClinicalTrials.gov

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

25

Start Date

2022-03-01

Completion Date

2026-03-30

Last Updated

2025-04-20

Healthy Volunteers

No

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

Locations (1)

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, United States