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Optimal Antibiotics for Operated Diabetic Foot Infections

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ClinicalTrials.gov Identifier: NCT04081792
Recruitment Status : Recruiting
First Posted : September 9, 2019
Last Update Posted : September 9, 2019
Sponsor:
Information provided by (Responsible Party):
Balgrist University Hospital

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 Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 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 : September 4, 2019
Estimated Primary Completion Date : August 20, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Number of Participants with a clinical and microbiological remission of treated infection at 2 months [ Time Frame: Through study completion, at 2 months ]
    Remission is the absence of any anamnesis or clinics for persistent or recurrent infection


Secondary Outcome Measures :
  1. Anatomical Amputation Level Determination by MRI [ Time Frame: 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.

  2. Rates of adverse events of antibiotic therapy [ Time Frame: Through study completion, at 2 months ]
    Outcome of antibiotic-related adverse events

  3. Duration of wound healing time [ Time Frame: Through study completion, at 2 months ]
    Evolution of wound size under therapy and off-loading over time. Wound Score.

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

  5. Scales of Patient's satisfaction [ Time Frame: 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.

  6. Statistical evaluation of risk factors for failure of remission [ Time Frame: 2 years ]
    Multivariate Cox Regression analyses



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04081792


Contacts
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Contact: Ilker Uckay, PD MD +41443863705 ilker.uckay@balgrist.ch
Contact: Felix Waibel, MD +41443865759 felix.waibel@balgrist.ch

Locations
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Switzerland
Balgrist University Hospital Recruiting
Zürich, Zurich, Switzerland, 8008
Contact: Ilker Uçkay, PD, MD    +41 44 386 37 05    ilker.uckay@balgrist.ch   
Contact: Felix Waibel, MD    +41 44 386 57 59    felix.waibel@balgrist.ch   
Sub-Investigator: Martin C Berli, MD         
Sub-Investigator: Madlaina Schöni, MD         
Sub-Investigator: Jan Burkhard, MD         
Sub-Investigator: Dominique Holy, MD         
Sub-Investigator: Sabrina Catanzaro, RN         
Sub-Investigator: Kati Sairanen, RN         
Sub-Investigator: Tanja Huber, Pharm D         
Sponsors and Collaborators
Balgrist University Hospital
Investigators
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Study Director: Ilker Uçkay, PD MD Balgrist University Hospital, Zurich, Switzerland

Publications of Results:
Other Publications:
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Responsible Party: Balgrist University Hospital
ClinicalTrials.gov Identifier: NCT04081792     History of Changes
Other Study ID Numbers: DFI_Cohort
First Posted: September 9, 2019    Key Record Dates
Last Update Posted: September 9, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: not yet determined in detail
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: In 2022
Access Criteria: Upon reasonable request upon the contact authors

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Balgrist University Hospital:
diabetic foot; osteomyelitis; amputation; antibiotics
Additional relevant MeSH terms:
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Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Infection
Communicable Diseases
Focal Infection
Diabetic Foot
Surgical Wound
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Wounds and Injuries