RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2020-08-01
Study Completion:2025-06-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03966027

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Adults 18 and ove
  2. 2. Positive for diabetes
  3. 3. Positive monofilament test
  4. 4. Isolated ankle fracture (non-pilon) and undergoing operative intervention within 3 weeks of fracture
  5. 5. Weight less than 275 (124kg)
  6. 6. Can tolerate and comply with brace
  7. 7. No signs of pre-existing charcot arthroplasty or ankle deformity
  1. 1. Children
  2. 2. Pregnant patients
  3. 3. No signs of diabetes complicated by neuropathy
  4. 4. Non-operative ankle fractures
  5. 5. Multiple extremity injury
  6. 6. Cannot follow post-operative protocol
  7. 7. Chronic ankle fractures receiving surgery beyond 3 weeks of injury

Contacts and Locations

Study Contact

Vicki L Jones, MEd
CONTACT
573-882-7583
jonesvicki@umsystem.edu
Ennio Rizzo Esposito, MD
CONTACT
3468126445
eardvb@health.missouri.edu

Principal Investigator

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

Study Locations (Sites)

University of Missouri Health System
Columbia, Missouri, 65212
United States

Collaborators and Investigators

Sponsor: Kyle Schweser MD

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

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

Study Start Date2020-08-01
Study Completion Date2025-06-15

Study Record Updates

Study Start Date2020-08-01
Study Completion Date2025-06-15

Terms related to this study

Keywords Provided by Researchers

  • Diabetic Ankle Fractures

Additional Relevant MeSH Terms

  • Ankle Fractures