Status:
ACTIVE_NOT_RECRUITING
Patient Specific 3D Printed Diabetic Insoles to Reduce Plantar Pressure
Lead Sponsor:
VA Office of Research and Development
Conditions:
Diabetes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 investigat...
Detailed Description
It is estimated that, globally, a lower extremity amputation takes place every 30 seconds, and that 85% of these amputations are the result of diabetic foot ulcers. Plantar foot ulcers develop, in par...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2026
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT05301478
Start Date
March 1 2022
End Date
March 30 2026
Last Update
April 20 2025
Active Locations (1)
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1
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, United States, 98108-1532