standard of care insole for Diabetes

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Diabetesstandard of care insole - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Active NMES
2
Standard Care
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Study Objectives

1 Primary · 0 Secondary · Reporting Duration: all interventions will be assessed in the second study visit ~ 1 month after the first

Month 1
Plantar pressure

Trial Safety

Safety Progress

1 of 3

Similar Trials

2
Active NMES
3
Standard Care
1
RN Standard care coordination and disease management

Trial Design

1 Treatment Group

Diabetic with elevated plantar pressure
1 of 1

Experimental Treatment

25 Total Participants · 1 Treatment Group

Primary Treatment: standard of care insole · No Placebo Group · N/A

Diabetic with elevated plantar pressureExperimental Group · 3 Interventions: standard of care insole, 3D Printed Insole - pressure based, 3D Printed Insole - FEA · Intervention Types: Device, Device, Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: all interventions will be assessed in the second study visit ~ 1 month after the first

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,483 Previous Clinical Trials
2,742,042 Total Patients Enrolled
22 Trials studying Diabetes
13,620 Patients Enrolled for Diabetes
Brittney C Muir, PhDPrincipal InvestigatorVA Puget Sound Health Care System Seattle Division, Seattle, WA

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have plantar pressure greater than or equal to 250 KPa (assessed at first study visit).
You have a valid prescription for custom foot orthotics or you are currently using custom foot orthotics.
References

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