Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID03966027

Immediate Versus Delayed Weight Bearing after Surgery for Diabetic Ankle Fractures Using a Hindfoot Offloading Brace

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

25

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying diabetic patients who have undergone surgery for ankle fractures to determine whether starting weight bearing immediately after surgery using a special hindfoot offloading brace affects healing and complications compared to the usual practice of delayed weight bearing. The study aims to see if immediate weight bearing maintains ankle motion, does not increase complications, and leads to good patient outcomes and satisfaction. This is important because diabetic patients often have nerve damage that affects pain perception and pressure sensing, increasing the risk of complications after ankle surgery. Participants will be randomly assigned to one of two groups after their ankle surgery: one group will start immediate weight bearing using a custom-made hindfoot offloading brace designed to limit pressure on the heel, while the other group will follow a standard delayed weight-bearing protocol without the brace. The brace fitting occurs post-surgery and takes about 1-2 weeks. Follow-up visits include wound care, counseling, physical therapy, ankle X-rays, and brace adjustments at various time points up to one year. Participants will undergo regular clinical assessments including surveys measuring foot and ankle function and general health, ankle radiographs to monitor healing, and skin checks to prevent complications. Visits occur frequently in the first few months, with longer-term follow-up to one year. Safety is monitored by tracking adverse events over 12 months. If a participant leaves the study early, they continue with standard post-operative care. Total study participation can last up to one year after surgery.

CONDITIONS

Brief 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) treated with surgery within 3 weeks of injury
  • Weight less than 275 pounds (124 kg)
  • Able to tolerate and comply with wearing a foot brace
  • No signs of Charcot arthropathy or ankle deformity before injury
Not Eligible

You will not qualify if you...

  • Children under 18 years
  • Pregnant patients
  • Diabetic patients without neuropathy
  • Ankle fractures treated without surgery
  • Multiple injuries involving more than one limb
  • Unable to follow post-operative study protocol
  • Chronic ankle fractures undergoing surgery more than 3 weeks after injury

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 1 year

Participants undergo surgery to fix the ankle fracture and follow either an immediate or delayed weight-bearing rehabilitation protocol using a hindfoot offloading brace or standard care.

Visits at 2 weeks, 3 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks, 14 weeks, 16 weeks, 26 weeks, and 1 year

Follow-up

Duration - Up to 1 year

Participants continue post-operative rehabilitation and monitoring including surveys, ankle radiographs, skin checks, and brace adjustments to assess healing and outcomes.

Multiple visits as part of treatment visits listed above

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

E

Ennio Rizzo Esposito, MD

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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Published Research Related To This Trial

A protocol for treatment of unstable ankle fractures using transarticular fixation in patients with diabetes mellitus and loss of protective sensibility.

Mihir M Jani, William M Ricci, Joseph Borrelli...

https://pubmed.ncbi.nlm.nih.gov/14655888

The effects of assistive devices on the oxygen cost, cardiovascular stress, and perception of nonweight-bearing ambulation.

C G Holder, E M Haskvitz, A Weltman

https://pubmed.ncbi.nlm.nih.gov/8220412