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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. Trial (Amputation) Soft tissue - short antibiotic arm | Experimental | The intervention group consists of 1 day of postoperative antibiotic therapy for eventual residual soft tissue infection after amputation. |
|
| 1. Trial (Amputation) Soft tissue - long antibiotic arm | Active Comparator | The control group consists of 4 days duration of postoperative antibiotic therapy for eventual residual soft tissue infection after amputation. |
|
| 1. Trial (Amputation) Bone - short antibiotic arm | Experimental | The intervention group consists of 1 week of postoperative antibiotic therapy for eventual residual bone infection / contamination in the proximal bone stump after amputation. |
|
| 1. Trial (Amputation) Bone - long antibiotic arm | Active Comparator | The intervention group consists of 3 weeks of postoperative antibiotic therapy for eventual residual bone infection / contamination in the proximal bone stump after amputation. |
|
| 2.Trial (soft tissue infection) - short antibiotic arm | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antibiotic therapy | Procedure | Postoperative randomizations regarding the duration of systemic antibiotics |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Rates of adverse events of antibiotic therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ilker Uçkay, PD MD | Balgrist University Hospital, Zurich, Switzerland | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Balgrist University Hospital | Zurich | Canton of Zurich | 8008 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29508677 | Background | 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. | |
| 25015390 | Background | 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. |
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not yet determined in detail
In 2022
Upon reasonable request upon the contact authors
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 30, 2022 | Jul 1, 2022 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D000072836 | Surgical Wound |
| D007239 | Infections |
| D017719 | Diabetic Foot |
| D010019 | Osteomyelitis |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000890 | Anti-Infective Agents |
| ID | Term |
|---|---|
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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The intervention group consists of 10 days of post-debridement antibiotic therapy for non-amputated diabetic foot soft tissue infection.
|
| 2. Trial (soft tissue infection) - long antibiotic arm | Active Comparator | The control group consists of 20 days of post-debridement antibiotic therapy for non-amputated diabetic foot soft tissue infection. |
|
| 2. Trial (osteomyelitis) - short antibiotic arm | Experimental | The intervention group consists of 3 weeks of post-debridement antibiotic therapy for non-amputated diabetic foot osteomyelitis. |
|
| 2. Trial (osteomyelitis) - long antibiotic arm | Active Comparator | The control group consists of 6 weeks of post-debridement antibiotic therapy for non-amputated diabetic foot osteomyelitis. |
|
Outcome of antibiotic-related adverse events |
| Through study completion, at 2 months |
| Duration of wound healing time | Evolution of wound size under therapy and off-loading over time. Wound Score. | Through study completion, at 2 months |
| Numbers of Cost and resource reductions | Overall hospitalization and treatment costs; in Swiss Francs | Through study completion, at 2 months |
| 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 |
| Statistical evaluation of risk factors for failure of remission | Multivariate Cox Regression analyses | 2 years |
| 31008367 | Result | 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):e00059. doi: 10.1002/edm2.59. eCollection 2019 Apr. |
| 30664029 | Result | 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. |
| 30129109 | Result | 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 Sep 21. |
| 41464652 | Derived | Zendeli F, Jedrusik A, Schaefer RO, Albrecht D, Betz M, Waibel FWA, Grober T, Kuhne N, Konneker S, Uckay I. Pathogen-Specific Risk for Iterative Surgical Debridement in Orthopedic Infections: A Prospective Multicohort Analysis. J Clin Med. 2025 Dec 10;14(24):8750. doi: 10.3390/jcm14248750. |
| 31915048 | Derived | Waibel F, Berli M, Catanzaro S, Sairanen K, Schoni M, Boni T, Burkhard J, Holy D, Huber T, Bertram M, Laubli K, Frustaci D, Rosskopf A, Botter S, Uckay I. Optimization of the antibiotic management of diabetic foot infections: protocol for two randomized controlled trials. Trials. 2020 Jan 8;21(1):54. doi: 10.1186/s13063-019-4006-z. |
| D016523 |
| Foot Ulcer |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
| D001850 | Bone Diseases, Infectious |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |