Optimal Antibiotics for Operated Diabetic Foot Infections

Sponsor

Balgrist University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04081792

Collaborator

(none)

436

Enrollment

Location

Arms

38.9

Anticipated Duration (Months)

11.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Foot Infection Surgical Wound Antibiotic Side Effect Infection	Procedure: Antibiotic therapy	N/A

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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

436 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Optimization of the Surgical and Medical Management of Diabetic Foot Infections

Actual Study Start Date :

Sep 4, 2019

Anticipated Primary Completion Date :

Aug 20, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1. Trial (Amputation) Soft tissue - short antibiotic arm The intervention group consists of 1 day of postoperative antibiotic therapy for eventual residual soft tissue infection after amputation.	Procedure: Antibiotic therapy Postoperative randomizations regarding the duration of systemic antibiotics
Active Comparator: 1. Trial (Amputation) Soft tissue - long antibiotic arm The control group consists of 4 days duration of postoperative antibiotic therapy for eventual residual soft tissue infection after amputation.	Procedure: Antibiotic therapy Postoperative randomizations regarding the duration of systemic antibiotics
Experimental: 1. Trial (Amputation) Bone - short antibiotic arm The intervention group consists of 1 week of postoperative antibiotic therapy for eventual residual bone infection / contamination in the proximal bone stump after amputation.	Procedure: Antibiotic therapy Postoperative randomizations regarding the duration of systemic antibiotics
Active Comparator: 1. Trial (Amputation) Bone - long antibiotic arm The intervention group consists of 3 weeks of postoperative antibiotic therapy for eventual residual bone infection / contamination in the proximal bone stump after amputation.	Procedure: Antibiotic therapy Postoperative randomizations regarding the duration of systemic antibiotics
Experimental: 2.Trial (soft tissue infection) - short antibiotic arm The intervention group consists of 10 days of post-debridement antibiotic therapy for non-amputated diabetic foot soft tissue infection.	Procedure: Antibiotic therapy Postoperative randomizations regarding the duration of systemic antibiotics
Active Comparator: 2. Trial (soft tissue infection) - long antibiotic arm The control group consists of 20 days of post-debridement antibiotic therapy for non-amputated diabetic foot soft tissue infection.	Procedure: Antibiotic therapy Postoperative randomizations regarding the duration of systemic antibiotics
Experimental: 2. Trial (osteomyelitis) - short antibiotic arm The intervention group consists of 3 weeks of post-debridement antibiotic therapy for non-amputated diabetic foot osteomyelitis.	Procedure: Antibiotic therapy Postoperative randomizations regarding the duration of systemic antibiotics
Active Comparator: 2. Trial (osteomyelitis) - long antibiotic arm The control group consists of 6 weeks of post-debridement antibiotic therapy for non-amputated diabetic foot osteomyelitis.	Procedure: Antibiotic therapy Postoperative randomizations regarding the duration of systemic antibiotics

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.
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.
Numbers of Cost and resource reductions [Through study completion, at 2 months]
Overall hospitalization and treatment costs; in Swiss Francs
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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