NCT04081792

Optimal Antibiotics for Operated Diabetic Foot Infections

Completed NA Last updated 17 June 2025

What this trial tests

NA trial testing Antibiotic therapy in Diabetic Foot Infection in 643 participants. Completed in 1 March 2025.

Timeline

4 September 2019

Primary endpoint
31 December 2024

1 March 2025

Quick facts

Lead sponsor	Balgrist University Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	643
Start date	4 September 2019
Primary completion	31 December 2024
Estimated completion	1 March 2025
Sites	1 location across Switzerland

Drugs / interventions tested

• Antibiotic therapy

Conditions studied

• Diabetic Foot Infection — all drugs for Diabetic Foot Infection →
• Surgical Wound — all drugs for Surgical Wound →
• Antibiotic Side Effect — all drugs for Antibiotic Side Effect →
• Infection — all drugs for Infection →

Sponsor

Balgrist University Hospital

Who can join

Adults 18 to 99, any sex, with Diabetic Foot Infection or Surgical Wound. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Diabetic foot problems, especially infections (DFI), require multiple resources including iterative surgeries and amputations, long-lasting antibiotic therapies, education, off-loading and eventually revascularization and appropriate foot-ware. Treatment is complicated, multidisciplinary, and marked with a high risk of recurrences.

This is a retrospective and prospective cohort with side studies of pathologies and academic research questions that cannot be separated from each other.

The investigators establish a retro-and prospective cohort of diabetic foot problems (ambulatory and hospitalized patients) and perform side studies to reduce the incidence of complications, and to reduce recurrences of DFI, cost and adverse events related to therapies.

Cohort: Prospective and retrospective cohort of all diabetic foot problems with emphasis on surgical and infectious variables.

Trial 1 (Randomized trial on residual infection after amputation):

Determination of the level of amputation per MRI followed by a randomization concerning the duration of post-amputation systemic antibiotic therapy, if there is residual bone infection.

Trial 2 (Randomized trial on infection without amputation):

Determination of the duration of systemic antibiotic therapy in diabetic foot infections without Amputation of the infection.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Optimization of the antibiotic management of diabetic foot infections: protocol for two randomized controlled trials.
   Waibel F, Berli M, Catanzaro S, Sairanen K, et al · · 2020 · cited 26× · PMID 31915048 · DOI 10.1186/s13063-019-4006-z
2. How good are clinicians in predicting the presence of <i>Pseudomonas</i> spp. in diabetic foot infections? A prospective clinical evaluation.
   Uçkay I, Holy D, Schöni M, Waibel FWA, et al · · 2021 · cited 12× · PMID 33855224 · DOI 10.1002/edm2.225
3. Pathogen-Specific Risk for Iterative Surgical Debridement in Orthopedic Infections: A Prospective Multicohort Analysis.
   Zendeli F, Jędrusik A, Schaefer RO, Albrecht D, et al · · 2025 · cited 1× · PMID 41464652 · DOI 10.3390/jcm14248750
4. Pathogen-Specific Risk for Iterative Surgical Debridement in Orthopedic Infections: A Prospective Multicohort Analysis
   Zendeli F, Jedrusik A, Schäfer RO, Albrecht D, et al · · 2025 · DOI 10.20944/preprints202511.0784.v1
5. Potential Origins of Acute Surgical Site Infections in Non-Traumatic Orthopedic Surgery - a Single-Center Prospective Evaluation
   Lüer PS, Albrecht D, Furrer PR, Ansorge A, et al · · 2025 · DOI 10.21203/rs.3.rs-6541947/v1
6. Optimization of the antibiotic management of diabetic foot infections - Protocol for two randomized controlled trials
   Waibel FW, Berli M, Catanzaro S, Sairanen K, et al · · 2019 · DOI 10.21203/rs.2.15844/v2