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Orthotics

Custom 3D Printed Insoles for Diabetes Foot Health (3D Insole Trial)

N/A

Recruiting

Led By Brittney C Muir, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Valid prescription for diabetic custom foot orthotics or current diabetic CFO user

Age 18+ years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up all interventions will be assessed in the second study visit ~ 1 month after the first

Awards & highlights

3D Insole Trial Summary

This trial is testing if custom foot orthotics improve foot health and mobility for people who are at increased risk of developing foot ulcers, compared to those who don't wear them. The study involves up to 12 visits lasting up to 4 hours, and participants are paid for their time.

Who is the study for?

This trial is for adults over 18 with diabetes who need custom foot orthotics and have high plantar pressure. It's not for those with recent foot ulcers, terminal illness, special footwear needs beyond insoles, non-ambulatory individuals, pregnant women, or those unable to consent.Check my eligibility

What is being tested?

The study tests if custom-made diabetic insoles created using two different 3D printing methods can improve foot health and mobility compared to standard care insoles. Participants will visit the VA Hospital in Seattle up to 12 times for assessments.See study design

What are the potential side effects?

While there are no direct side effects from wearing the orthotics being tested, discomfort or skin irritation may occur due to new pressure distribution from the custom insoles.

3D Insole Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have a prescription for diabetic foot supports.

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I am 18 years old or older.

3D Insole Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ all interventions will be assessed in the second study visit ~ 1 month after the first

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~all interventions will be assessed in the second study visit ~ 1 month after the first

This trial's timeline: 3 weeks for screening, Varies for treatment, and all interventions will be assessed in the second study visit ~ 1 month after the first for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Plantar pressure

3D Insole Trial Design

1Treatment groups

Experimental Treatment

Group I: Diabetic with elevated plantar pressureExperimental Treatment3 Interventions

Diabetic with elevated plantar pressure

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,611 Previous Clinical Trials

3,305,259 Total Patients Enrolled

22 Trials studying Diabetes

13,585 Patients Enrolled for Diabetes

Brittney C Muir, PhDPrincipal InvestigatorVA Puget Sound Health Care System Seattle Division, Seattle, WA

1 Previous Clinical Trials

7 Total Patients Enrolled

Media Library

3D Printed Insole - FEA (Orthotics) Clinical Trial Eligibility Overview. Trial Name: NCT05301478 — N/A

Diabetes Research Study Groups: Diabetic with elevated plantar pressure

Diabetes Clinical Trial 2023: 3D Printed Insole - FEA Highlights & Side Effects. Trial Name: NCT05301478 — N/A

3D Printed Insole - FEA (Orthotics) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05301478 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals have been selected to participate in this clinical investigation?

"Absolutely. The clinical trial database reveals that this experiment, which was posted on March 1st 2022, is actively seeking volunteers. 25 participants need to be enrolled from one research centre."

Answered by AI

Is there still room in this clinical trial for new participants?

"According to the information posted clinicaltrials.gov, recruitment for this medical study is ongoing. It was published on March 1st 2022 and had its most recent update on April 28th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Patient Specific 3D Printed Diabetic Insoles to Reduce Plantar Pressure

2022. "Patient Specific 3D Printed Diabetic Insoles to Reduce Plantar Pressure". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05301478.