7-day oral antibiotic after surgery for people with diabetes and lower-leg fractures.
Official title: Extended Oral Antibiotic Prophylaxis in Diabetic Patients With Lower Extremity Fracture: A Multicenter Pilot Randomized Controlled Trial
Run by Texas Tech University Health Sciences Center, El Paso · NCT07561541 · Data updated 2026-11-12
This trial will test whether taking a 7-day antibiotic pill after surgery lowers wound infection risk in adults with poorly controlled diabetes who had surgery to fix a broken bone in the lower leg, ankle, or foot.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Texas Tech University Health Sciences Center, El Paso Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (Los Angeles, California and 2 other locations) |
| Status | Recruiting |
| Started | April 1, 2026 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | May 8, 2026 |
| Trial ID | NCT07561541 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with a closed lower-extremity fracture needing surgical fixation and poorly controlled diabetes (HbA1c >7.0 or random glucose >200 mg/dL), who can consent and speak English or Spanish, are ideal candidates.
✕Probably not a fit
Patients with open fractures, an active infection needing antibiotics, immunocompromised status, end-stage renal disease that prevents safe dosing, pregnancy or breastfeeding, known allergy to the study antibiotics, or inability to follow-up are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults with poorly controlled diabetes and a closed lower-extremity fracture requiring surgical fixation are randomized to either a 7-day course of oral prophylactic antibiotic (cefadroxil 500 mg twice daily, with alternatives for allergy or MRSA) or to standard perioperative care without extended antibiotics. All participants receive standard IV perioperative antibiotics and the same fracture care, with follow-up contact about one week after surgery and clinic visits at 3 weeks, 6 weeks, and 3 months. Primary outcomes include superficial and deep surgical site infection within 90 days, with secondary outcomes of antibiotic-related adverse effects and medication adherence. The trial aims to balance potential infection reduction against safety and antibiotic stewardship concerns.
Why it matters
Potential benefit: If effective, a short, targeted 7-day oral antibiotic could reduce postoperative wound infections and related complications in high-risk diabetic patients after lower-extremity fracture surgery.
How similar studies have gone: Some observational studies and small trials suggest extended antibiotics may reduce infections in high-risk orthopedic patients, but randomized evidence specifically in poorly controlled diabetic fracture patients is limited and mixed.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Low extremity fracture requiring surgical treatment * Uncontrolled diabetes (Hemoglobin A1c \> 7.0 or random glucose \> 200 mg/dL) * Age 18 years or older * Able to provide informed consent * English or Spanish speaker Exclusion Criteria: * Known allergy to prescribed antibiotic and pre-determined alternatives * Open fractures * Current infection requiring antibiotic treatment * Immunocompromised status (chemotherapy, immunosuppressant medications) * End-stage renal disease that medication dosing cannot be adjusted for * Pregnant or breast-feeding * Unable to comply with follow-up
Where it's running
-
University of Southern California
Los Angeles, California, United States Recruiting -
University Medical Center of El Paso
El Paso, Texas, United States Recruiting -
Texas Tech Health El Paso
El Paso, Texas, United States Recruiting
Study contacts
- Study coordinator: Taylor M Yong, MD, MS
- Email: tayong@ttuhsc.edu
- Phone: 915-215-5480
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.