Optimal Antibiotics for Operated Diabetic Foot Infections

  • STATUS
    Recruiting
  • End date
    Dec 1, 2022
  • participants needed
    436
  • sponsor
    Balgrist University Hospital
Updated on 24 July 2022
antibiotics
wound care
wound treatment

Summary

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.

Description

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).

Details
Condition Diabetic Foot Infection, Surgical Wound, Antibiotic Side Effect, Infection
Treatment Antibiotic therapy
Clinical Study IdentifierNCT04081792
SponsorBalgrist University Hospital
Last Modified on24 July 2022

Eligibility

Yes No Not Sure

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
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