Immediate vs. Delayed Weight Bearing for Diabetic Ankle Fractures
This study is looking at the best way for people with diabetes to recover after surgery for an ankle fracture. Typically, people with diabetes are told to avoid putting weight on their ankle for a long time after surgery. This study wants to see if starting to put weight on the ankle sooner, using a special brace that takes pressure off the heel (hindfoot offloading brace), is just as safe and effective. Researchers will compare this "immediate weight bearing" approach to the usual "delayed weight bearing" method. They will look at any problems that happen over 12 months. You might be able to join if you are an adult with diabetes, have an ankle fracture that needs surgery, and meet other specific health requirements.
- Study design
- This is an interventional study that plans to enroll up to 25 participants. Participants will be randomly assigned to either the immediate or delayed weight-bearing group.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for adverse events for 12 months after the intervention.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Immediate Vs. Delayed Weight Bearing Postoperative Protocol in Diabetic Ankle Fractures
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Kyle M Schweser, MD · PRINCIPAL_INVESTIGATOR · Assistant Professor Orthopaedic Trauma/Foot and Ankle
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Adverse Events12 months
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).