Immediate Vs. Delayed Weight Bearing Postoperative Protocol in Diabetic Ankle Fractures
Recruiting now · Not applicable
Conditions studied: Ankle Fractures
In brief
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
Key facts
- Study ID
- NCT03966027
- Run by
- Kyle Schweser MD
- People needed
- 25
- Starts
- 2020-08-01
- Expected to finish
- 2028-06-15
- Last updated by the study team
- 2026-08-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adults 18 and ove
- Positive for diabetes
- Positive monofilament test
- Isolated ankle fracture (non-pilon) and undergoing operative intervention within 3 weeks of fracture
- Weight less than 275 (124kg)
- Can tolerate and comply with brace
- No signs of pre-existing charcot arthroplasty or ankle deformity
You may not qualify if…
- Children
- Pregnant patients
- No signs of diabetes complicated by neuropathy
- Non-operative ankle fractures
- Multiple extremity injury
- Cannot follow post-operative protocol
- Chronic ankle fractures receiving surgery beyond 3 weeks of injury
Where it is running
- University of Missouri Health System — Columbia, Missouri, United States (enrolling)
Full record on ClinicalTrials.gov
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