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

NCT03966027 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-08-24

No results posted yet for this study

Summary

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

Interventions

OTHER

Postoperative protocol (Immediate weight bearing)

After ORIF of the ankle fracture, the patient will be randomized to follow an immediate weight bearing rehabilitation protocol using an offloading hindfoot brace

OTHER

Postoperative Protocol (Delayed Weight Bearing)

After ORIF of the ankle fracture, the patient will be randomized to follow a standard delayed weight-bearing rehabilitation protocol

Sponsors & Collaborators

  • Kyle Schweser MD

    lead OTHER

Principal Investigators

  • Kyle M Schweser, MD · Assistant Professor Orthopaedic Trauma/Foot and Ankle

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-01
Primary Completion
2026-06-15
Completion
2026-06-15

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03966027 on ClinicalTrials.gov