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Immediate vs. Delayed Weight Bearing After Surgery for Diabetic Ankle Fracture (Diabetic Ankle Trial)
N/A
Recruiting
Led By Kyle M Schweser, MD
Research Sponsored by Kyle Schweser MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Isolated ankle fracture (non-pilon) and undergoing operative intervention within 3 weeks of fracture
Weight less than 275 (124kg)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Diabetic Ankle Trial Summary
This trial is testing if immediate weight bearing with a hindfoot offloading brace is better than non-immediate weight bearing for people with operatively managed diabetic ankle fractures.
Who is the study for?
This trial is for adults over 18 with diabetes who have recently had surgery for an ankle fracture. They must be under 275 pounds, able to use a brace, and not have other foot deformities or multiple injuries. It's not suitable for pregnant individuals, children, those unable to follow the protocol, or if neuropathy complicates their diabetes.Check my eligibility
What is being tested?
The study compares two post-surgery care methods for diabetic patients with ankle fractures: one group will start putting weight on their foot right away using a special brace; the other will delay weight bearing according to traditional protocols. The goal is to see which method leads to better movement and satisfaction without increasing complications.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include discomfort from immediate weight bearing or issues related to extended non-weight bearing such as muscle weakness or cardiovascular problems.
Diabetic Ankle Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a broken ankle (not the lower part) and will have surgery within 3 weeks of the injury.
Select...
I weigh less than 275 pounds (124 kg).
Select...
I have diabetes.
Select...
I do not have any pre-existing foot or ankle deformities.
Diabetic Ankle Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse Events
Secondary outcome measures
AAOS Foot and Ankle Score
PROMIS Score
Diabetic Ankle Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Hindfoot Offloading Braces / Immediate Weight-bearingExperimental Treatment1 Intervention
Diabetic patients over 18 years of age who sustained an isolated (non-pilon) ankle fracture will undergo ORIF of the ankle fracture within 3 weeks of the event
Group II: No Hindfoot Offloading Braces / Delayed Weight-BearingPlacebo Group1 Intervention
Diabetic patients over 18 years of age who sustained an isolated (non-pilon) ankle fracture will undergo ORIF of the ankle fracture within 3 weeks of the event
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Who is running the clinical trial?
Kyle Schweser MDLead Sponsor
2 Previous Clinical Trials
90 Total Patients Enrolled
Kyle M Schweser, MDPrincipal InvestigatorAssistant Professor Orthopaedic Trauma/Foot and Ankle
1 Previous Clinical Trials
50 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a broken ankle (not the lower part) and will have surgery within 3 weeks of the injury.I have injuries to more than one limb.I weigh less than 275 pounds (124 kg).I am under 18 years old.I have a broken ankle that doesn't require surgery.I do not have diabetes with nerve damage.I am having surgery for an ankle fracture that happened over 3 weeks ago.I am 18 years old or older.I have diabetes.I do not have any pre-existing foot or ankle deformities.You are pregnant.
Research Study Groups:
This trial has the following groups:- Group 1: No Hindfoot Offloading Braces / Delayed Weight-Bearing
- Group 2: Hindfoot Offloading Braces / Immediate Weight-bearing
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still vacancies for participants in this clinical trial?
"Affirmative. According to the clinicaltrials.gov database, this investigation is currently looking for recruits and was initially posted on August 1st 2020 with an edit made as recently as November 16th 2022. A total of 25 individuals from one location are necessary for participation in this study."
Answered by AI
What is the current capacity of participants for this trial?
"Affirmative. According to clinicaltrials.gov, recruitment for this trial is currently in progress - it was initially posted on August 1st 2020 and recently modified on November 16th 2022. 25 individuals need to be enrolled from a single medical centre."
Answered by AI
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