N/A N=30 Other

Patient Specific 3D Printed Diabetic Insoles to Reduce Plantar Pressure

Diabetes

Bottom Line

View on ClinicalTrials.gov: NCT05301478 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2026

Primary outcome: Primary: Plantar Pressure - Standard of Care — 202.71 kPa

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: standard of care insole (Device); 3D Printed Insole - pressure based (Device); 3D Printed Insole - FEA (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: VA Office of Research and Development
Primary completion: Dec 2025

Outcome Measures

Outcome	Result	p-value
PRIMARY Plantar Pressure - Standard of Care	202.71	—
PRIMARY Plantar Pressure - Finite Element Insole	152.69	—
PRIMARY Plantar Pressure - Pressure Based Insole	156.50	—

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

Eligibility Criteria

Inclusion Criteria

Age 18+ years
Valid prescription for diabetic custom foot orthotics or current diabetic CFO user
Plantar pressure greater than or equal to250 KPa (assessed at first study visit)

Exclusion Criteria

Healed or non-healed foot ulcer within the last month
Prior amputation of more than 1 digit
Requirement for boots, custom shoes, or other specialty footwear for daily activities
Non-ambulatory status
Terminal illness that would make two-year survival unlikely
Pregnant (determined by self-report)
Inadequate cognitive function or language proficiency to consent to participate

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05301478). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.