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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)

Must not have

Multiple extremity injury

Non-operative ankle fractures

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a broken ankle (not the lower part) and will have surgery within 3 weeks of the injury.

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I weigh less than 275 pounds (124 kg).

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I have diabetes.

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I do not have any pre-existing foot or ankle deformities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have injuries to more than one limb.

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I have a broken ankle that doesn't require surgery.

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I do not have diabetes with nerve damage.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse Events

Secondary study objectives

AAOS Foot and Ankle Score

PROMIS Score

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

0 / 7Eligibility criteria met