Optimal antibiotics for treating diabetic foot infections after surgery
Optimization of the Surgical and Medical Management of Diabetic Foot Infections
This study is testing which antibiotics work best for people with diabetic foot infections after surgery to help reduce complications and prevent these infections from coming back.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 436 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Balgrist University Hospital Academic / other |
| Locations | 1 site (Zürich, Zurich) |
| Trial ID | NCT04081792 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of different antibiotic treatments for patients with diabetic foot infections, particularly those requiring surgical intervention. It includes both retrospective and prospective cohorts, focusing on reducing complications and recurrences associated with these infections. Patients will be randomized to receive varying durations of antibiotic therapy based on their specific conditions, including post-amputation and post-debridement scenarios. The goal is to establish the best practices for antibiotic use in this patient population.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with diabetic foot infections or ischemia requiring surgical intervention.
Not a fit: Patients with infections located more than 5 cm from the amputation site or those requiring extensive systemic antibiotic therapy for other infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols for diabetic foot infections, reducing complications and recurrence rates.
How similar studies have performed: Other studies have shown promising results with tailored antibiotic therapies for diabetic foot infections, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Diabetic foot infections or ischemia/necrosis with surgical amputation/disarticulation level in vicinity of MRI signs of infection * At least two months of follow-up from hospitalization * Patient signing to participate, including acceptance of local wound care, -off-loading and arterial re-vascularization (if clinically indicated). Exclusion Criteria: * At least 5 cm of distance between amputation level and infection. * Any concomitant infection requiring more than 5 days of systemic antibiotic therapy * Eventual osteosynthesis material not removed
Where this trial is running
Zürich, Zurich
- Balgrist University Hospital — Zürich, Zurich, Switzerland (Recruiting)
Study contacts
- Study coordinator: Ilker Uckay, PD MD
- Email: ilker.uckay@balgrist.ch
- Phone: +41443863705
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.