Comparing immediate and delayed weight bearing after surgery for diabetic ankle fractures
Official title: Immediate Vs. Delayed Weight Bearing Postoperative Protocol in Diabetic Ankle Fractures
Run by University of Missouri-Columbia · NCT03966027 · Data updated 2026-11-12
This study tests whether letting people with diabetic ankle fractures walk right away after surgery, using a special brace, helps them recover better than waiting to bear weight.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 25 (estimated) |
| Sponsor | University of Missouri-Columbia Academic / other |
| Locations | 1 site (Columbia, Missouri) |
| Status | Recruiting |
| Started | August 1, 2020 |
| Main results expected | June 15, 2027 |
| Study ends | June 15, 2028 |
| Registry record updated | August 3, 2026 |
| Trial ID | NCT03966027 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 with diabetes who have sustained an isolated ankle fracture and can comply with the postoperative protocol.
✕Probably not a fit
Patients who may not benefit include children, pregnant individuals, and those with multiple extremity injuries or chronic ankle fractures requiring surgery beyond three weeks.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effects of immediate versus delayed weight bearing protocols in patients with diabetic ankle fractures following surgical intervention. It aims to determine whether immediate weight bearing with a hindfoot offloading brace can maintain adequate motion and reduce complications compared to traditional delayed weight bearing methods. The study will enroll up to 25 adult patients who have experienced isolated ankle fractures and will undergo surgery within three weeks of injury. Participants will be monitored for outcome scores and patient satisfaction post-surgery.
Why it matters
Potential benefit: If successful, this approach could improve recovery outcomes and patient satisfaction for individuals with diabetic ankle fractures.
How similar studies have gone: While similar studies have explored weight bearing protocols, this specific approach in diabetic patients is relatively novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adults 18 and ove 2. Positive for diabetes 3. Positive monofilament test 4. Isolated ankle fracture (non-pilon) and undergoing operative intervention within 3 weeks of fracture 5. Weight less than 275 (124kg) 6. Can tolerate and comply with brace 7. No signs of pre-existing charcot arthroplasty or ankle deformity Exclusion Criteria: 1. Children 2. Pregnant patients 3. No signs of diabetes complicated by neuropathy 4. Non-operative ankle fractures 5. Multiple extremity injury 6. Cannot follow post-operative protocol 7. Chronic ankle fractures receiving surgery beyond 3 weeks of injury
Where it's running
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University of Missouri Health System
Columbia, Missouri, United States Recruiting
Study contacts
- Principal investigator: Kyle M Schweser, MD — Assistant Professor Orthopaedic Trauma/Foot and Ankle
- Study coordinator: Vicki L Jones, MEd
- Email: jonesvicki@umsystem.edu
- Phone: 573-882-7583
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.