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 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
Conditions:
🦠 Ankle Fractures
🗓️ Study Start (Actual) 1 August 2020
🗓️ Primary Completion (Estimated) 15 June 2025
✅ Study Completion (Estimated) 15 June 2025
👥 Enrollment (Estimated) 25
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Columbia, Missouri, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 24 May 2019
  • First Submitted that Met QC Criteria 24 May 2019
  • First Posted 29 May 2019

Study Record Updates

  • Last Update Submitted that Met QC Criteria 27 July 2023
  • Last Update Posted 28 July 2023
  • Last Verified July 2023