The Effects of Heel Distraction Height on Foot Loading With Carbon Fiber Custom Dynamic Orthoses

Study acronym: CDODistract
StatusRecruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 1 year 2 months later Jun 1, 2026 → Aug 1, 2027
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Record History

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  1. Primary and study completion pushed from Jun 1, 2026 to Aug 1, 2027
    • Eligibility criteria expanded, about 17 words
    • Secondary endpoints: details revised at 2 of 7 entries
  2. Re-verified, no change to tracked fieldsv7
  3. Site contact updatedv6
  4. Primary and study completion dates pushed to Jun 1, 2026
    • Site contact updated
    v5
  5. Trial status: Not Yet Recruiting to Recruitingv4 Show 5 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Jul 1, 2024 to Aug 16, 2024
    • Eligibility criteria shortened, about 40 words
    • Secondary endpoints: 4 to 7
    • Study description shortened, about 32 words
Show 2 earlier versionsHide 2 earlier versions
  1. Start date: Mar 1, 2024 to Jul 1, 2024v3
  2. Start date: Jan 1, 2024 to Mar 1, 2024
    • Primary completion date: Jan 1, 2025 to May 1, 2025
    • Study completion date: May 1, 2025 to Sep 1, 2025
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Carbon fiber custom dynamic orthoses (CDOs) and unloading ankle foot orthoses (AFOs) have shown varying levels of success in reducing forces acting on different regions of the bottom of the foot during gait. CDOs and unloading AFOs have shown differing offloading capabilities across different regions of the foots (hindfoot, midfoot, forefoot) which may be related to a distinct difference between CDOs and unloading AFOs: CDOs do not suspend, or distract, the foot away from the footplate. The purpose of this study is to determine the effects of CDOs and heel distraction height (the distance between the heel and the footplate) on limb loading and motion during gait as well as patient reported pain, and comfort.
Trial Details
NCT Number NCT06127316
Lead Sponsor University of Iowa
Collaborators: Fabtech Systems
Conditions
(from sponsor)		 Traumatic Lower Limb Injury
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov