Recruiting

Immediate vs. Delayed

Sponsor:

Kyle Schweser MD

Code:

NCT03966027

Conditions

Ankle Fractures

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Postoperative protocol (Immediate weight bearing)

Postoperative Protocol (Delayed Weight Bearing)

Study Details

Brief 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

Study ID

NCT03966027

Start date

Aug 1, 2020

Status verified date

Jul, 2026

Completion date

Jun 15, 2028

Anticipated

Primary completion date

Jun 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Adults 18 and ove
2. Positive for diabetes
3. Positive monofilament test
4. Isolated ankle fracture (non-pilon) and undergoing operative intervention within 3 weeks of fracture
5. Weight less than 275 (124kg)
6. Can tolerate and comply with brace
7. No signs of pre-existing charcot arthroplasty or ankle deformity

Exclusion Criteria:

1. Children
2. Pregnant patients
3. No signs of diabetes complicated by neuropathy
4. Non-operative ankle fractures
5. Multiple extremity injury
6. Cannot follow post-operative protocol
7. Chronic ankle fractures receiving surgery beyond 3 weeks of injury

Study Design

Enrollment

25 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Hindfoot Offloading Braces / Immediate Weight-bearing

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

placebo comparator: No Hindfoot Offloading Braces / Delayed Weight-Bearing

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

Interventions

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

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

Primary outcome measure

  • Adverse Events [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Locations

University of Missouri Health System

Recruiting

Columbia, Missouri, United States, 65212

Contacts

More Information

Sponsor

Kyle Schweser MD

Last update posted

Aug 3, 2026

Last verified

Jul, 2026

Keywords

  • Diabetic Ankle Fractures

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Kyle Schweser MD on 2026-08-03.