Patient Specific 3D Printed Diabetic Insoles to Reduce Plantar Pressure (3D Insole)

March 6, 2024 updated by: VA Office of Research and Development

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 part, due to high loading and mechanical stress to the soft tissues of the foot. Custom standard of care insoles aim to reduce regions of the foot that experience excessive plantar pressures by redistributing pressure to other areas.

Limitations in the effectiveness of standard of care insoles, however, result in rates of ulceration that remain unacceptably high. Meanwhile, a revolution in 3D printing technologies, material properties, and digital manufacturing pipelines are enabling a wave of innovative solutions that are improving outcomes in many areas of medicine. The investigators aim to leverage these techniques to create novel patient-specific 3D printed insoles with personalized metamaterials which the investigators believe will demonstrate superior offloading performance.

Personalized metamaterials are 3D printed materials formed from lattice patterns derived from patient specific characteristics, resulting in insoles that are uniquely matched to the patient's needs. The aim of this study is to determine if 3D printed insoles with personalized metamaterials reduce plantar pressures for at-risk areas of the foot better than standard of care insoles. The investigators will manufacture three different insoles, namely the standard of care (SC), 3D printed pressure based (3DP-PB), and finite element optimized (3DP-FE) insoles. 3DP-PB insoles will be designed from plantar foot shape and dynamic plantar pressure while the 3DP-FE insoles will be designed from simulations of participant's feet interacting with different insole designs to optimize the insole shape and metamaterial properties. In a repeated measures study, the investigators will measure peak plantar pressure and pressure time integral for each type of insole with a group of 25 participants who have diabetes and elevated forefoot pressure. The investigators hypothesize that the 3D printed insoles comprised of personalized metamaterials derived from plantar measurements (3DP-PB) will have greater reductions in the peak plantar pressure and pressure time integral than the SC insoles (H1).

Additionally, the investigators hypothesize that, relative to the other two insoles, insoles optimized through patient specific finite element simulations (3DP-FE) will have the greatest reduction in peak plantar pressure and pressure time integral (H2). To facilitate the clinical translation of the novel 3D printed insoles the investigators will carry out focus groups with patients and clinicians to gain their early feedback and insights. Results from these focus groups will be qualitatively synthesized into actionable improvements to the insoles. Novel insoles that utilize 3D printing fabrication may provide enhanced protection from foot ulcers that frequently progress to amputation. Moreover, digital manufacturing technologies and 3D fabrication methods have relatively low barriers to mass production, which can greatly expedite translation into clinics. The VA is widely recognized as a leader in health care innovation. The development of custom 3D printed insoles that may reduce risk for amputation is well-aligned with VA's spirit of innovation and is supported by the VA mission "To care for him who shall have borne the battle." Reducing rates of ulceration in the Veteran population has the potential to greatly reduce incidence of lower-limb amputations and improve the quality of life for Veterans.

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98108-1532
        • Recruiting
        • VA Puget Sound Health Care System Seattle Division, Seattle, WA
        • Contact:
        • Principal Investigator:
          • Brittney C Muir, PhD
        • Sub-Investigator:
          • Patrick Aubin, PhD MS BS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diabetic with elevated plantar pressure
Device: standard of care insole
standard of care diabetic insole
Device: 3D Printed Insole - pressure based
3D Printed Insole - pressure based
Device: 3D Printed Insole - FEA
3D Printed Insole - FEA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plantar pressure
Time Frame: all interventions will be assessed in the second study visit ~ 1 month after the first
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Brittney C Muir, PhD, VA Puget Sound Health Care System Seattle Division, Seattle, WA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Estimated)

March 30, 2025

Study Completion (Estimated)

March 30, 2025

Study Registration Dates

First Submitted

March 16, 2022

First Submitted That Met QC Criteria

March 28, 2022

First Posted (Actual)

March 29, 2022

Study Record Updates

Last Update Posted (Actual)

March 7, 2024

Last Update Submitted That Met QC Criteria

March 6, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • A3539-R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All individual participant data collected will be de-identified and placed in publically accessible online data repositories.

IPD Sharing Time Frame

Data will be posted ad-hoc on an ongoing basis.

IPD Sharing Access Criteria

Once posted, the data is available to the public.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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