Patient Specific 3D Printed Diabetic Insoles to Reduce Plantar Pressure

NCT05301478 | Active Not Recruiting FDA Device

• 1 other identifier: A3539-R
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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 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

Conditions

Diabetes

Keywords

Diabetic Accommodative insoles; 3D printing; 3D printed insoles; Personalized Metamaterials; FEA modeling

Outcome Measures

Primary Outcomes (1)

• Plantar pressure

  pressure on the bottom of the feet between insole conditions

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

Study Arms (1)

Diabetic with elevated plantar pressure

EXPERIMENTAL

Diabetic with elevated plantar pressure

Device: standard of care insole; Device: 3D Printed Insole - pressure based; Device: 3D Printed Insole - FEA

Interventions

standard of care insole DEVICE

standard of care diabetic insole

Diabetic with elevated plantar pressure

3D Printed Insole - pressure based DEVICE

3D Printed Insole - pressure based

Diabetic with elevated plantar pressure

3D Printed Insole - FEA DEVICE

3D Printed Insole - FEA

Diabetic with elevated plantar pressure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, 98108-1532, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Brittney C Muir, PhD

  VA Puget Sound Health Care System Seattle Division, Seattle, WA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Wear custom foot orthotics during in laboratory testing for up to four hours

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: March 29, 2022
• Study Start: March 1, 2022
• Primary Completion: March 30, 2025
• Study Completion: March 30, 2026
• Last Updated: April 20, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be posted ad-hoc on an ongoing basis.
• Access Criteria: Once posted, the data is available to the public.

Locations

US (1)