Infection Clinical Trial
Official title:
Optimization of the Surgical and Medical Management of 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.
Status | Recruiting |
Enrollment | 436 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Balgrist University Hospital | Zürich | Zurich |
Lead Sponsor | Collaborator |
---|---|
Balgrist University Hospital |
Switzerland,
Coster MC, Rosengren BE, Bremander A, Brudin L, Karlsson MK. Comparison of the Self-reported Foot and Ankle Score (SEFAS) and the American Orthopedic Foot and Ankle Society Score (AOFAS). Foot Ankle Int. 2014 Oct;35(10):1031-6. doi: 10.1177/1071100714543647. Epub 2014 Jul 11. — View Citation
Gariani K, Lebowitz D, von Dach E, Kressmann B, Lipsky BA, Uckay I. Remission in diabetic foot infections: Duration of antibiotic therapy and other possible associated factors. Diabetes Obes Metab. 2019 Feb;21(2):244-251. doi: 10.1111/dom.13507. Epub 2018 — View Citation
Rossel A, Lebowitz D, Gariani K, Abbas M, Kressmann B, Assal M, Tscholl P, Stafylakis D, Uckay I. Stopping antibiotics after surgical amputation in diabetic foot and ankle infections-A daily practice cohort. Endocrinol Diabetes Metab. 2019 Feb 6;2(2):e000 — View Citation
Uckay I, Berli M, Sendi P, Lipsky BA. Principles and practice of antibiotic stewardship in the management of diabetic foot infections. Curr Opin Infect Dis. 2019 Apr;32(2):95-101. doi: 10.1097/QCO.0000000000000530. — View Citation
Uckay I, Jornayvaz FR, Lebowitz D, Gastaldi G, Gariani K, Lipsky BA. An Overview on Diabetic Foot Infections, including Issues Related to Associated Pain, Hyperglycemia and Limb Ischemia. Curr Pharm Des. 2018;24(12):1243-1254. doi: 10.2174/1381612824666180302145754. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants with a clinical and microbiological remission of treated infection at 2 months | Remission is the absence of any anamnesis or clinics for persistent or recurrent infection | Through study completion, at 2 months | |
Secondary | Anatomical Amputation Level Determination by MRI | 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. | At study entry, Day O | |
Secondary | Rates of adverse events of antibiotic therapy | Outcome of antibiotic-related adverse events | Through study completion, at 2 months | |
Secondary | Duration of wound healing time | Evolution of wound size under therapy and off-loading over time. Wound Score. | Through study completion, at 2 months | |
Secondary | Numbers of Cost and resource reductions | Overall hospitalization and treatment costs; in Swiss Francs | Through study completion, at 2 months | |
Secondary | Scales of Patient's satisfaction | 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. | Through study completion, at 2 months | |
Secondary | Statistical evaluation of risk factors for failure of remission | Multivariate Cox Regression analyses | 2 years |
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