Patient Specific 3D Printed Diabetic Insoles to Reduce Plantar Pressure

Completed · Not applicable

Conditions studied: Diabetes

In brief

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 facts

Study ID

NCT05301478

Run by

VA Office of Research and Development

People needed

30

Starts

2022-03-01

Expected to finish

2025-12-30

Last updated by the study team

2026-06-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• VA Puget Sound Health Care System Seattle Division, Seattle, WA — Seattle, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.