Patient Specific 3D Printed Diabetic Insoles to Reduce Plantar Pressure (NCT05301478) | Clinical Trial Compass
CompletedNot Applicable
Patient Specific 3D Printed Diabetic Insoles to Reduce Plantar Pressure
United States30 participantsStarted 2022-03-01
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Plantar Pressure - Standard of Care
Timeframe: all interventions will be assessed in the second study visit ~ 1 month after the first