Diabetic Fibular Nail Study (NCT05204485) | Clinical Trial Compass
TerminatedNot Applicable
Diabetic Fibular Nail Study
Stopped: Low enrollment making completion of the study impossible, relocation of both the PI and Co-PI
United States2 participantsStarted 2022-03-07
Plain-language summary
Our null hypothesis is that fibular intramedullary fixation (IMFN) does not impact complication rates when compared to standard of care treatment with open reduction and internal fixation (ORIF). There are no current or past RCTs comparing these fixation techniques to one another in diabetic patients. There is good data supporting both the use of intramedullary fixation for fibular fractures alone, and in high-risk patient populations (elderly, and diabetics). However, the effectiveness of these methods with respect to each other has never been investigated. The knowledge gained will allow us to potentially influence and adapt protocols to treat this patient population. Additionally, resources available at our institution provide a supportive framework with which to maintain contact with patients after hospital discharge. These key factors will allow us to perform a robust analysis of this population, to include outcomes measures of function and complications.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18 or older
* Unstable ankle fracture
* Diagnosis of Diabetes:
* Fasting BG \> 120
* Non-fasting BG \> 200
* HbA1c \> 6.5
Exclusion Criteria:
* Patients not meeting inclusion criteria (stable fracture patterns, non-diabetics)
* Poly-trauma patients (multiple \[\>2\] extremity injuries that interfere and/or limit patient mobilization
* Open fractures
* Delayed presentation of fracture (\>4 weeks)
* Fractures that the treating surgeon indicates requires a posterior approach to achieve stability
* Patients with an active infection or wound at the ankle
* Utilizing worker's compensation at the time of screening
* Any previous ligament or fracture surgery on the index ankle
* Inflammatory rheumatic disease or other rheumatic disease
* Immune compromised patients (hepatitis, HIV, etc.)
* Non-English speaking patients
* Unwilling or unable to follow study protocol
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.