CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled / 30 target
Drug / intervention
standard of care insole +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05301478
NCT05301478N/ACompletedOn Track (0.6/mo)Completion was 6mo ago

Patient Specific 3D Printed Diabetic Insoles to Reduce Plantar Pressure

VA Office of Research and Development·interventional·Posted Mar 29, 2022·Updated Jun 1, 2026

In Brief

A clinical study evaluating standard of care insole, 3D Printed Insole - pressure based, and 1 other intervention for Diabetes. Completed, enrolled 30 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedMar 29, 2022
Enrollment StartMar 1, 2022
Primary CompletionDec 30, 2025
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 4.3 years ago

Arms & Interventions

Diabetic with elevated plantar pressureexperimental

Diabetic with elevated plantar pressure

Device: standard of care insoleDevice: 3D Printed Insole - pressure basedDevice: 3D Printed Insole - FEA

Interventions

standard of care insoledevice

standard of care diabetic insole

3D Printed Insole - pressure baseddevice

3D Printed Insole - pressure based

3D Printed Insole - FEAdevice

3D Printed Insole - FEA