Antibiotic Side Effect, Diabetic Foot Infection, Infection, Surgical Wound
Conditions
Keywords
diabetic foot; osteomyelitis; amputation; antibiotics
Brief 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.
Detailed 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).
Interventions
PROCEDUREAntibiotic therapy
Postoperative randomizations regarding the duration of systemic antibiotics
Sponsors
Balgrist University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with a clinical and microbiological remission of treated infection at 2 months | Through study completion, at 2 months | Remission is the absence of any anamnesis or clinics for persistent or recurrent infection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rates of adverse events of antibiotic therapy | Through study completion, at 2 months | Outcome of antibiotic-related adverse events |
| Duration of wound healing time | Through study completion, at 2 months | Evolution of wound size under therapy and off-loading over time. Wound Score. |
| Anatomical Amputation Level Determination by MRI | 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. |
| Scales of Patient's satisfaction | 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. |
| Statistical evaluation of risk factors for failure of remission | 2 years | Multivariate Cox Regression analyses |
| Numbers of Cost and resource reductions | Through study completion, at 2 months | Overall hospitalization and treatment costs; in Swiss Francs |
Countries
Switzerland
Outcome results
None listed