NCT07561541 Extended Oral Antibiotic Prophylaxis in Diabetic Fracture Patients
| NCT ID | NCT07561541 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Texas Tech University Health Sciences Center, El Paso |
| Condition | Fracture Lower Leg |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-04-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 40 participants in total. It began in 2026-04-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to learn if taking an antibiotic pill for 7 days after surgery reduces the risk of wound infection in adults with poorly controlled diabetes who have surgery to fix a broken bone in the leg, ankle, or foot. It will also learn about the safety of the extended antibiotic course. The main questions it aims to answer are: Does a 7-day antibiotic course after surgery lower the rate of wound infection within 90 days? What medical problems do participants have when taking the extended antibiotic course? Researchers will compare a 7-day course of an oral antibiotic (cefadroxil) to standard care (no additional antibiotics after surgery) to see if the extended course reduces infections. Participants will: Take an antibiotic pill or receive standard care for 7 days after surgery Receive a phone call from the study team about 1 week after surgery Visit the clinic at 3 weeks, 6 weeks, and 3 months after surgery for checkups
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07561541 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Fracture Lower Leg. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07561541 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07561541 currently recruiting?
Yes, NCT07561541 is actively recruiting participants. Contact the research team at tayong@ttuhsc.edu for enrollment information.
Where is the NCT07561541 trial being conducted?
This trial is being conducted at Los Angeles, United States, El Paso, United States, El Paso, United States.
Who is sponsoring the NCT07561541 clinical trial?
NCT07561541 is sponsored by Texas Tech University Health Sciences Center, El Paso. The trial plans to enroll 40 participants.