Optimal Antibiotics for Operated Diabetic Foot Infections

Infection Clinical Trial

Official title:

Optimization of the Surgical and Medical Management of Diabetic Foot Infections

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04081792
• Other study ID #: DFI_Cohort
• Status: Recruiting
• Phase: N/A
• Start date: September 4, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2023
• Source: Balgrist University Hospital
• Contact: Ilker Uckay, PD MD
• Phone: +41443863705
• Email: ilker.uckay[@]balgrist.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Antibiotic Side Effect
• Communicable Diseases
• Diabetic Foot
• Diabetic Foot Infection
• Infection
• Infections
• Surgical Wound

Intervention

Procedure:
• Antibiotic therapy
Postoperative randomizations regarding the duration of systemic antibiotics

Locations

Country	Name	City	State
Switzerland	Balgrist University Hospital	Zürich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Balgrist University Hospital

Country where clinical trial is conducted

Switzerland, 

References & Publications (5)

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

Outcome

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