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Completed

NCT Number: NCT04081792

Optimal Antibiotics for Operated Diabetic Foot Infections

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.

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Key information

Conditions

Diabetic Foot Infection Antibiotic Side Effect Bone Diseases Bone Diseases, Infectious Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Infection Infections Leg Ulcer Musculoskeletal Diseases Osteomyelitis Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Surgical Wound Vascular Diseases Wounds and Injuries

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Balgrist University Hospital

Zurich, Canton of Zurich, 8008, Switzerland

About this study

Trial 1: At enrollment (Day 1), the investigator will prescribe empiric antibiotic treatment based on instructions provided in the protocol and determine the most appropriate route of administration (oral or IV) according to the patient's condition. Patients will be randomized in the ratio 1:1 between 1 versus 4 days for post-amputation soft tissue infections; and between 1 versus 3 weeks if there is microbiologically proven residual bone infection/contamination in the proximal stump samples of the residual bone.

Trial 2: At enrollment (Day 1), the investigator will prescribe empiric antibiotic treatment based on instructions provided in the protocol and determine the most appropriate route of administration (oral or IV) according to the patient's condition. Patients will be randomized in the ratio 1:1 between 10 versus 20 days for post-debridement soft tissue infections; and between 3 versus 6 weeks for diabetic foot osteomyelitis post.-debridement (without amputation).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Antibiotic therapy

Procedure

Postoperative randomizations regarding the duration of systemic antibiotics

Primary outcomes

  1. Number of Participants with a clinical and microbiological remission of treated infection at 2 months

    Time frame: Through study completion, at 2 months

    Remission is the absence of any anamnesis or clinics for persistent or recurrent infection

Secondary outcomes

  1. Anatomical Amputation Level Determination by MRI

    Time frame: At study entry, Day O

    Evaluation of the accuracy of the extension of infection. Surgical decision for amputation level per magnetic resonance imaging when compared to microbiology, histology and intraoperative assessment.

  2. Rates of adverse events of antibiotic therapy

    Time frame: Through study completion, at 2 months

    Outcome of antibiotic-related adverse events

  3. Duration of wound healing time

    Time frame: Through study completion, at 2 months

    Evolution of wound size under therapy and off-loading over time. Wound Score.

  4. Numbers of Cost and resource reductions

    Time frame: Through study completion, at 2 months

    Overall hospitalization and treatment costs; in Swiss Francs

  5. Scales of Patient's satisfaction

    Time frame: Through study completion, at 2 months

    Questionnaires and Scores (e.g. AOFAS Score) ranging from 0 to 1. Alternatively, a home made Likert Scale ranging from 0 to 7 Points will be used.

  6. Statistical evaluation of risk factors for failure of remission

    Time frame: 2 years

    Multivariate Cox Regression analyses

Sponsors and collaborators

Lead sponsor

Balgrist University Hospital

Other

Registry information

Official study title

Optimization of the Surgical and Medical Management of Diabetic Foot Infections

Important dates

Study start
2019
Primary completion
2024
Study completion
2025
First posted
Sep 9, 2019
Registry last updated
Jun 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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