Immediate Vs. Delayed Weight Bearing Postoperative Protocol in Diabetic Ankle Fractures (Diabetic Ankle)

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

Study Overview

• Status: Recruiting
• Conditions: Ankle Fractures
• Intervention / Treatment: Other: Postoperative protocol (Immediate weight bearing); Other: Postoperative Protocol (Delayed Weight Bearing)

Detailed Description

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

Patients will be recruited from the trauma and foot & ankle service lines. Patients who have experienced an isolated ankle fracture (excluding pilon fracture) and will undergo operative fixation within 3 weeks of injury will be approached for consent. Patients will then be screened based on the inclusion and exclusion criteria. Up to 25 patients will be enrolled

The following protocol will be applied after enrollment

1. Pre-operatively

   a. Hemoglobin A1c will also be collected from each patient if it has not been performed within the last 30 days.

2. Post-operatively a. Post-surgery i. Standard of Care:

1. Placement into short leg, non-weight bearing splint to allow for wound healing and brace fabrication ii. Research Specific:

1. Fitted for brace (will be custom made and take approximately 1-2 weeks) b. 2 week visit (standard of care timepoint) i. Standard of Care:

1. Placed into compression stockings
2. Counseling regarding skin checks and diabetic skin care
3. Physical therapy prescription given ii. Research Specific

1. Placement into brace so it offloads the hindfoot to 15 pounds of pressure or less 2. Education by prosthetist, physiatrist, and/or attending physician about proper brace wear and maintenance, and the importance of weight bearing only in brace.

c. 3 Week visit (not standard of care timepoint) i. Research Specific

1. Ankle radiographs d. 4 weeks, 6 weeks, 12 Weeks, 26 weeks, and 1 year visits (standard of care time points) i. Standard of Care

1. Surveys (PROMIS, AAOS Foot and Ankle)
2. Ankle Radiographs ii. Research Specific

1. Counseling regarding brace wear 2. Brace adjustments as needed e. 8 week, 10 week, 14 week, 16 week, (non-standard of care biweekly visits until healing occurs) i. Research Specific

1. Ankle Radiographs (if early failure is suspected)
2. Skin Check

Upon study completion, patients will continue with post-operative rehab following the surgeon's standard of care. If a patients is removed prematurely or if the study ends prematurely, they will receive standard of care procedures going forward

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ennio Rizzo Esposito, MD; Phone Number: 3468126445; Email: eardvb@health.missouri.edu
• Study Contact Backup: Name: Vicki L Jones, MEd; Phone Number: 573-882-7583; Email: jonesvicki@umsystem.edu

Study Locations

• United States
  • Missouri
    • Columbia, Missouri, United States, 65212
      • Recruiting
      • University of Missouri Health System
      • Contact: Stacee Clawson, BSN, RN; Phone Number: 573-884-9017; Email: clawsons@health.missouri.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Other: 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
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	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: Severity;; Unanticipated Adverse Device Effect (UADE); Seriousness (Serious Adverse Event (SAE), Non-serious AE);; Device-Relatedness (Unrelated, Possibly Related, Probably Related, Definitely Related);; Procedure-Relatedness (Unrelated, Possibly Related, Probably Related, Definitely Related).	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AAOS Foot and Ankle Score	The AAOS foot and ankle questionnaire is a patient-administrated 25-item survey specifically developed for foot and ankle-related disability. The questionnaire is divided into two scales, the Foot and Ankle Core scale, comprised of 20 questions and the Shoe Comfort Scale with five questions. The questions themselves are distributed among five different categories: Pain (9 items), function (6 items), stiffness and swelling (2 items), giving way (3 items) and shoe comfort (5 items). Answers are then measured on a scale of 1 to 5 or 6, with 1 being the best outcome score.	12 Months
PROMIS Score	The Patient-Reported Outcomes Measurement Information System® (PROMIS) is a flexible set of tools designed to measure self-reported physical, mental and social health and wellbeing. PROMIS instruments contain a fixed number of items from seven PROMIS domains: depression; anxiety; physical function; pain interference; fatigue; sleep disturbance; and ability to participate in social roles and activities. The questionarie assesses each of the 7 PROMIS domains with 4 questions. The questions are ranked on a 5-point Likert Scale. There is also one 11-point rating scale for pain intensity. Norm-based scores are calculated for each domain on the PROMIS measures, so that a score of 50 represents the mean or average of the reference population. A score of 60 means that the person is one standard deviation above the reference population (standard deviation = 10).	12 Months

Collaborators and Investigators

• Sponsor: Kyle Schweser MD
• Investigators: Principal Investigator: Kyle M Schweser, MD, Assistant Professor Orthopaedic Trauma/Foot and Ankle

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Estimated): June 15, 2025
• Study Completion (Estimated): June 15, 2025

Study Registration Dates

• First Submitted: May 24, 2019
• First Submitted That Met QC Criteria: May 24, 2019
• First Posted (Actual): May 29, 2019

Study Record Updates

• Last Update Posted (Actual): July 28, 2023
• Last Update Submitted That Met QC Criteria: July 27, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Diabetic Ankle Fractures
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Ankle Injuries; Fractures, Bone; Ankle Fractures
• Other Study ID Numbers: 2014997

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No