NCT03966027

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
1mo left

Started Aug 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress98%
Aug 2020Jun 2026

First Submitted

Initial submission to the registry

May 24, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 29, 2019

Completed
1.2 years until next milestone

Study Start

First participant enrolled

August 1, 2020

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2026

Last Updated

August 24, 2025

Status Verified

August 1, 2025

Enrollment Period

5.9 years

First QC Date

May 24, 2019

Last Update Submit

August 22, 2025

Conditions

Ankle Fractures

Keywords

Diabetic Ankle Fractures

Outcome Measures

Primary Outcomes (1)

  • Adverse Events

    Adverse Events by type over time, severity, seriousness, and relatedness. AEs will be tabulated and summarized as counts and percentages. AEs will also be cross-tabulated according to: 1. Severity; 2. Unanticipated Adverse Device Effect (UADE) 3. Seriousness (Serious Adverse Event (SAE), Non-serious AE); 4. Device-Relatedness (Unrelated, Possibly Related, Probably Related, Definitely Related); 5. Procedure-Relatedness (Unrelated, Possibly Related, Probably Related, Definitely Related).

    12 months

Secondary Outcomes (2)

  • AAOS Foot and Ankle Score

    12 Months

  • PROMIS Score

    12 Months

Study Arms (2)

Hindfoot Offloading Braces / Immediate Weight-bearing

EXPERIMENTAL

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

Other: Postoperative protocol (Immediate weight bearing)

No Hindfoot Offloading Braces / Delayed Weight-Bearing

PLACEBO COMPARATOR

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

Other: Postoperative Protocol (Delayed Weight Bearing)

Interventions

Postoperative protocol (Immediate weight bearing)OTHER

After ORIF of the ankle fracture, the patient will be randomized to follow an immediate weight bearing rehabilitation protocol using an offloading hindfoot brace

Hindfoot Offloading Braces / Immediate Weight-bearing
Postoperative Protocol (Delayed Weight Bearing)OTHER

After ORIF of the ankle fracture, the patient will be randomized to follow a standard delayed weight-bearing rehabilitation protocol

No Hindfoot Offloading Braces / Delayed Weight-Bearing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Children
  • Pregnant patients
  • No signs of diabetes complicated by neuropathy
  • Non-operative ankle fractures
  • Multiple extremity injury
  • Cannot follow post-operative protocol
  • Chronic ankle fractures receiving surgery beyond 3 weeks of injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Missouri Health System

Columbia, Missouri, 65212, United States

RECRUITING

Related Publications (5)

  • Raghav A, Khan ZA, Labala RK, Ahmad J, Noor S, Mishra BK. Financial burden of diabetic foot ulcers to world: a progressive topic to discuss always. Ther Adv Endocrinol Metab. 2018 Jan;9(1):29-31. doi: 10.1177/2042018817744513. Epub 2017 Dec 12.

    PMID: 29344337BACKGROUND

  • Jani MM, Ricci WM, Borrelli J Jr, Barrett SE, Johnson JE. A protocol for treatment of unstable ankle fractures using transarticular fixation in patients with diabetes mellitus and loss of protective sensibility. Foot Ankle Int. 2003 Nov;24(11):838-44. doi: 10.1177/107110070302401106.

    PMID: 14655888BACKGROUND

  • Shehab DK, Al-Jarallah KF, Abraham M, Mojiminiyi OA, Al-Mohamedy H, Abdella NA. Back to basics: ankle reflex in the evaluation of peripheral neuropathy in type 2 diabetes mellitus. QJM. 2012 Apr;105(4):315-20. doi: 10.1093/qjmed/hcr212. Epub 2011 Nov 8.

    PMID: 22071964BACKGROUND

  • Wukich DK, Kline AJ. The management of ankle fractures in patients with diabetes. J Bone Joint Surg Am. 2008 Jul;90(7):1570-8. doi: 10.2106/JBJS.G.01673.

    PMID: 18594108RESULT

  • Holder CG, Haskvitz EM, Weltman A. The effects of assistive devices on the oxygen cost, cardiovascular stress, and perception of nonweight-bearing ambulation. J Orthop Sports Phys Ther. 1993 Oct;18(4):537-42. doi: 10.2519/jospt.1993.18.4.537.

    PMID: 8220412RESULT

MeSH Terms

Conditions

Ankle Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesAnkle InjuriesLeg Injuries

Study Officials

  • Kyle M Schweser, MD

    Assistant Professor Orthopaedic Trauma/Foot and Ankle

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vicki L Jones, MEd

CONTACT

573-882-7583jonesvicki@umsystem.edu

Ennio Rizzo Esposito, MD

CONTACT

3468126445eardvb@health.missouri.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Diabetic patients with ankle fractures will be manage operatively and then randomized to be prescribed a hindfoot offloading brace 2 weeks after surgery or be randomized to follow a non-immediate weight bearing rehabilitation protocol
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor Orthopaedic Trauma/Foot and Ankle

Study Record Dates

First Submitted

May 24, 2019

First Posted

May 29, 2019

Study Start

August 1, 2020

Primary Completion (Estimated)

June 15, 2026

Study Completion (Estimated)

June 15, 2026

Last Updated

August 24, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

The Investigator will maintain all study records according to applicable University regulatory requirement(s). Hard copy records will be retained for at least 7 years after the last clinic follow-up visit at the Missouri Orthopaedic Institute in a locked filing cabinet. Electronic records will be retained for the same amount of time but on secured computers and servers. If the Investigator withdraws from the responsibility of keeping the study records, custody will be transferred to a person willing to accept the responsibility.

Locations

US(1)