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NCT03966027 · ClinicalTrials.gov registry record · NA
Immediate Vs. Delayed Weight Bearing Postoperative Protocol in Diabetic Ankle Fractures
A NA study of Ankle Fractures, sponsored by Kyle Schweser MD.
- Recruiting
- Registry status
- NA
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT03966027: Recruiting NA study of Ankle Fractures, sponsored by Kyle Schweser MD.
NCT03966027 is a NA study of Ankle Fractures that is actively recruiting participants, run by Kyle Schweser MD. The registered enrollment target is 25 participants, below the 251-participant average among 12 other Ankle Fractures trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03966027, a NA study of Ankle Fractures, is actively recruiting participants, sponsored by Kyle Schweser MD.
- RECRUITING
- Registry status
- NA
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study Summary
Operatively managed diabetic ankle fractures have significant risk for complications. The cause for failure is likely multifactorial, however, a component of failure has to do with an inability to process pain and pressure normally. This loss of protective sensation allows for an increase in abnormal stresses placed on the recently repaired fractures. Historically, diabetics have been kept non weight bearing for extended periods of time, which has its own functional and cardiovascular issues. The purpose of the study is to determine if a protocol of immediate weight bearing with a hindfoot offloading brace after surgically corrected ankle fracture in a diabetic patient will maintain adequate motion, have no difference in complications when compared to regular non-immediate weight bearing protocols, and lead to good outcome scores and patient satisfaction scores
Primary Outcome
Adverse Events by type over time, severity, seriousness, and relatedness. AEs will be tabulated and summarized as counts and percentages. AEs will also be cross-tabulated according to: 1. Severity; 2. Unanticipated Adverse Device Effect (UADE) 3. Seriousness (Serious Adverse Event (SAE), Non-serious AE); 4. Device-Relatedness (Unrelated, Possibly Related, Probably Related, Definitely Related); 5. Procedure-Relatedness (Unrelated, Possibly Related, Probably Related, Definitely Related).
Conditions Studied
Interventions
- OTHER Postoperative protocol (Immediate weight bearing)
- OTHER Postoperative Protocol (Delayed Weight Bearing)
Study Locations (1)
Missouri
- University of Missouri Health System - Columbia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2020-08-01 |
| Est. Completion | 2026-06-15 |
| Phase | NA |
What NCT03966027 shows while recruiting
NCT03966027 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 251-participant average among 12 other Ankle Fractures trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Ankle Fractures appearing as the primary indexed condition, and to 2 interventions - of which Postoperative protocol (Immediate weight bearing) is the first listed.
NCT03966027 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT03966027 about?
NCT03966027 is a clinical study titled "Immediate Vs. Delayed Weight Bearing Postoperative Protocol in Diabetic Ankle Fractures". Operatively managed diabetic ankle fractures have significant risk for complications. The cause for failure is likely multifactorial, however, a component of failure has to do with an inability to process pain and pressure normally. This loss of protective sensation allows for an increase in abnorma...
What is the current status of trial NCT03966027?
This trial is currently recruiting. It is a NA study. The enrollment target is 25 participants. The study started on 2020-08-01. Estimated completion is 2026-06-15.
What conditions does trial NCT03966027 study?
This clinical trial studies the following conditions: Ankle Fractures.
What interventions are being tested in trial NCT03966027?
The interventions under investigation include: Postoperative protocol (Immediate weight bearing) (OTHER), Postoperative Protocol (Delayed Weight Bearing) (OTHER).
Who is sponsoring clinical trial NCT03966027?
This trial is sponsored by Kyle Schweser MD, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03966027 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Ankle Fractures
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03966027's enrollment target sits among peer trials
25 11th of 12 higher than 2 of 12 other Ankle Fractures trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ankle Fractures trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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