Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT03966027

Immediate Vs. Delayed Weight Bearing Postoperative Protocol in Diabetic Ankle Fractures

Led by Kyle Schweser MD · Updated on 2025-08-24

25

Participants Needed

1

Research Sites

306 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Immediate Vs. Delayed Weight Bearing Postoperative Protocol in Diabetic Ankle Fractures

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults 18 years and older
  • Diagnosed with diabetes
  • Positive monofilament test indicating neuropathy
  • Isolated ankle fracture (non-pilon) requiring surgery within 3 weeks of injury
  • Weight less than 275 pounds (124 kg)
  • Able to tolerate and use a brace
  • No existing Charcot arthropathy or ankle deformity
Not Eligible

You will not qualify if you...

  • Children
  • Pregnant patients
  • Diabetes without neuropathy
  • Ankle fractures treated without surgery
  • Multiple injuries to limbs
  • Unable to follow postoperative protocol
  • Chronic ankle fractures with surgery delayed beyond 3 weeks after injury

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Missouri Health System

Columbia, Missouri, United States, 65212

Actively Recruiting

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Research Team

V

Vicki L Jones, MEd

CONTACT

E

Ennio Rizzo Esposito, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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