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Optimal Antibiotics for Operated Diabetic Foot Infections

Primary Purpose

Diabetic Foot Infection, Surgical Wound, Antibiotic Side Effect

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Antibiotic therapy
Sponsored by
Balgrist University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot Infection focused on measuring diabetic foot; osteomyelitis; amputation; antibiotics

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Balgrist University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

1. Trial (Amputation) Soft tissue - short antibiotic arm

1. Trial (Amputation) Soft tissue - long antibiotic arm

1. Trial (Amputation) Bone - short antibiotic arm

1. Trial (Amputation) Bone - long antibiotic arm

2.Trial (soft tissue infection) - short antibiotic arm

2. Trial (soft tissue infection) - long antibiotic arm

2. Trial (osteomyelitis) - short antibiotic arm

2. Trial (osteomyelitis) - long antibiotic arm

Arm Description

The intervention group consists of 1 day of postoperative antibiotic therapy for eventual residual soft tissue infection after amputation.

The control group consists of 4 days duration of postoperative antibiotic therapy for eventual residual soft tissue infection after amputation.

The intervention group consists of 1 week of postoperative antibiotic therapy for eventual residual bone infection / contamination in the proximal bone stump after amputation.

The intervention group consists of 3 weeks of postoperative antibiotic therapy for eventual residual bone infection / contamination in the proximal bone stump after amputation.

The intervention group consists of 10 days of post-debridement antibiotic therapy for non-amputated diabetic foot soft tissue infection.

The control group consists of 20 days of post-debridement antibiotic therapy for non-amputated diabetic foot soft tissue infection.

The intervention group consists of 3 weeks of post-debridement antibiotic therapy for non-amputated diabetic foot osteomyelitis.

The control group consists of 6 weeks of post-debridement antibiotic therapy for non-amputated diabetic foot osteomyelitis.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Rates of adverse events of antibiotic therapy
Outcome of antibiotic-related adverse events
Duration of wound healing time
Evolution of wound size under therapy and off-loading over time. Wound Score.
Numbers of Cost and resource reductions
Overall hospitalization and treatment costs; in Swiss Francs
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.
Statistical evaluation of risk factors for failure of remission
Multivariate Cox Regression analyses

Full Information

First Posted
August 5, 2019
Last Updated
February 28, 2023
Sponsor
Balgrist University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04081792
Brief Title
Optimal Antibiotics for Operated Diabetic Foot Infections
Official Title
Optimization of the Surgical and Medical Management of Diabetic Foot Infections
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 4, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Balgrist University Hospital

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Infection, Surgical Wound, Antibiotic Side Effect, Infection
Keywords
diabetic foot; osteomyelitis; amputation; antibiotics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
436 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1. Trial (Amputation) Soft tissue - short antibiotic arm
Arm Type
Experimental
Arm Description
The intervention group consists of 1 day of postoperative antibiotic therapy for eventual residual soft tissue infection after amputation.
Arm Title
1. Trial (Amputation) Soft tissue - long antibiotic arm
Arm Type
Active Comparator
Arm Description
The control group consists of 4 days duration of postoperative antibiotic therapy for eventual residual soft tissue infection after amputation.
Arm Title
1. Trial (Amputation) Bone - short antibiotic arm
Arm Type
Experimental
Arm Description
The intervention group consists of 1 week of postoperative antibiotic therapy for eventual residual bone infection / contamination in the proximal bone stump after amputation.
Arm Title
1. Trial (Amputation) Bone - long antibiotic arm
Arm Type
Active Comparator
Arm Description
The intervention group consists of 3 weeks of postoperative antibiotic therapy for eventual residual bone infection / contamination in the proximal bone stump after amputation.
Arm Title
2.Trial (soft tissue infection) - short antibiotic arm
Arm Type
Experimental
Arm Description
The intervention group consists of 10 days of post-debridement antibiotic therapy for non-amputated diabetic foot soft tissue infection.
Arm Title
2. Trial (soft tissue infection) - long antibiotic arm
Arm Type
Active Comparator
Arm Description
The control group consists of 20 days of post-debridement antibiotic therapy for non-amputated diabetic foot soft tissue infection.
Arm Title
2. Trial (osteomyelitis) - short antibiotic arm
Arm Type
Experimental
Arm Description
The intervention group consists of 3 weeks of post-debridement antibiotic therapy for non-amputated diabetic foot osteomyelitis.
Arm Title
2. Trial (osteomyelitis) - long antibiotic arm
Arm Type
Active Comparator
Arm Description
The control group consists of 6 weeks of post-debridement antibiotic therapy for non-amputated diabetic foot osteomyelitis.
Intervention Type
Procedure
Intervention Name(s)
Antibiotic therapy
Intervention Description
Postoperative randomizations regarding the duration of systemic antibiotics
Primary Outcome Measure Information:
Title
Number of Participants with a clinical and microbiological remission of treated infection at 2 months
Description
Remission is the absence of any anamnesis or clinics for persistent or recurrent infection
Time Frame
Through study completion, at 2 months
Secondary Outcome Measure Information:
Title
Anatomical Amputation Level Determination by MRI
Description
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.
Time Frame
At study entry, Day O
Title
Rates of adverse events of antibiotic therapy
Description
Outcome of antibiotic-related adverse events
Time Frame
Through study completion, at 2 months
Title
Duration of wound healing time
Description
Evolution of wound size under therapy and off-loading over time. Wound Score.
Time Frame
Through study completion, at 2 months
Title
Numbers of Cost and resource reductions
Description
Overall hospitalization and treatment costs; in Swiss Francs
Time Frame
Through study completion, at 2 months
Title
Scales of Patient's satisfaction
Description
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.
Time Frame
Through study completion, at 2 months
Title
Statistical evaluation of risk factors for failure of remission
Description
Multivariate Cox Regression analyses
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ilker Uckay, PD MD
Phone
+41443863705
Email
ilker.uckay@balgrist.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Felix Waibel, MD
Phone
+41443865759
Email
felix.waibel@balgrist.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilker Uçkay, PD MD
Organizational Affiliation
Balgrist University Hospital, Zurich, Switzerland
Official's Role
Study Director
Facility Information:
Facility Name
Balgrist University Hospital
City
Zürich
State/Province
Zurich
ZIP/Postal Code
8008
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ilker Uçkay, PD, MD
Phone
+41 44 386 37 05
Email
ilker.uckay@balgrist.ch
First Name & Middle Initial & Last Name & Degree
Felix Waibel, MD
Phone
+41 44 386 57 59
Email
felix.waibel@balgrist.ch
First Name & Middle Initial & Last Name & Degree
Martin C Berli, MD
First Name & Middle Initial & Last Name & Degree
Madlaina Schöni, MD
First Name & Middle Initial & Last Name & Degree
Jan Burkhard, MD
First Name & Middle Initial & Last Name & Degree
Dominique Holy, MD
First Name & Middle Initial & Last Name & Degree
Sabrina Catanzaro, RN
First Name & Middle Initial & Last Name & Degree
Kati Sairanen, RN
First Name & Middle Initial & Last Name & Degree
Tanja Huber, Pharm D

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
not yet determined in detail
IPD Sharing Time Frame
In 2022
IPD Sharing Access Criteria
Upon reasonable request upon the contact authors
Citations:
PubMed Identifier
29508677
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.
Results Reference
background
PubMed Identifier
25015390
Citation
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.
Results Reference
background
PubMed Identifier
31008367
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):e00059. doi: 10.1002/edm2.59. eCollection 2019 Apr.
Results Reference
result
PubMed Identifier
30664029
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.
Results Reference
result
PubMed Identifier
30129109
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 Sep 21.
Results Reference
result
PubMed Identifier
31915048
Citation
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.
Results Reference
derived

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Optimal Antibiotics for Operated Diabetic Foot Infections

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