custom orthoses with varying degrees of hindfoot posting for Flatfoot

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Flatfoot+3 More
custom orthoses with varying degrees of hindfoot posting - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study the effects of different orthotics on ankle osteoarthritis and adult-onset flat feet. A custom X-ray system will be used to measure foot bone motion. The goal is to find which orthotic design is most effective in improving function.

Eligible Conditions
  • Flatfoot
  • Ankle
  • Foot

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: immediate

immediate
peak hindfoot eversion
peak tibial rotation in degrees

Trial Safety

Safety Progress

1 of 3

Trial Design

3 Treatment Groups

control
1 of 3
flat foot
1 of 3
ankle OA
1 of 3

Active Control

Experimental Treatment

35 Total Participants · 3 Treatment Groups

Primary Treatment: custom orthoses with varying degrees of hindfoot posting · No Placebo Group · N/A

flat foot
Device
Experimental Group · 1 Intervention: custom orthoses with varying degrees of hindfoot posting · Intervention Types: Device
ankle OA
Device
Experimental Group · 1 Intervention: custom orthoses with varying degrees of hindfoot posting · Intervention Types: Device
controlNoIntervention Group · 1 Intervention: control · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: immediate

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,474 Previous Clinical Trials
2,741,699 Total Patients Enrolled
University of WashingtonOTHER
1,587 Previous Clinical Trials
1,567,188 Total Patients Enrolled
William R. Ledoux, PhDPrincipal InvestigatorVA Puget Sound Health Care System Seattle Division, Seattle, WA

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The person is not a candidate for surgery, but is undergoing conservative care.
The study found that people with ankle OA or PTTD were more likely to have a diagnosis of depression.
able to walk without difficulty for at least 15 meters, but has difficulty walking because of ankle OA or PTTD.
You are between 18 and 80 years of age.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 22nd, 2021

Last Reviewed: November 1st, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Washington100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
University of Washington100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%