Diabetic Foot InfectionNCT04081792
Optimal Antibiotics for Operated Diabetic Foot Infections
A study testing Antibiotic therapy in people with Diabetic Foot Infection and Surgical Wound, run by Balgrist University Hospital at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Diabetic Foot Infection, Surgical Wound, Antibiotic Side Effect
- What is being tested?
- Antibiotic therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 643 participants
- Where
- 1 siteSwitzerland
- Study dates
- 4 Sep 2019to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Balgrist University Hospital
Zurich, Canton of Zurich, 8008
About this study
Official title: Optimization of the Surgical and Medical Management of Diabetic Foot Infections
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.
Read more
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.
Read the 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).
- Being tested
- Antibiotic therapy
- Keywords
- diabetic foot; osteomyelitis; amputation; antibiotics
- Medical subject headings
- Surgical Wound, Infections, Diabetic Foot, Osteomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibiotic therapyProcedure or surgery
Postoperative randomizations regarding the duration of systemic antibiotics
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Antibiotic therapy |
| 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. Receives: Procedure: Antibiotic therapy |
| 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. Receives: Procedure: Antibiotic therapy |
| 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. Receives: Procedure: Antibiotic therapy |
| 2.Trial (soft tissue infection) - short antibiotic arm | Experimental | The intervention group consists of 10 days of post-debridement antibiotic therapy for non-amputated diabetic foot soft tissue infection. Receives: Procedure: Antibiotic therapy |
| 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. Receives: Procedure: Antibiotic therapy |
| 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. Receives: Procedure: Antibiotic therapy |
| 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. Receives: Procedure: Antibiotic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion, at 2 months
Secondary outcomes (6)
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.
Measured: At study entry, Day O
Rates of adverse events of antibiotic therapy
Outcome of antibiotic-related adverse events
Measured: Through study completion, at 2 months
Duration of wound healing time
Evolution of wound size under therapy and off-loading over time. Wound Score.
Measured: Through study completion, at 2 months
Numbers of Cost and resource reductions
Overall hospitalization and treatment costs; in Swiss Francs
Measured: 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.
Measured: Through study completion, at 2 months
Statistical evaluation of risk factors for failure of remission
Multivariate Cox Regression analyses
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start4 Sep 2019
- Primary completion31 Dec 2024
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 643 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balgrist University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ilker Uçkay, PD MD, Study director, Balgrist University Hospital, Zurich, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04081792
- Sponsor's protocol ID
- DFI_Cohort
- Status last verified
- Feb 2025
- First submitted
- 5 Aug 2019
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: not yet determined in detail
Publications
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.
PubMed 29508677Coster 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.
PubMed 25015390Rossel 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.
PubMed 31008367Uckay 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.
PubMed 30664029Gariani 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.
PubMed 30129109Zendeli 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.
PubMed 41464652Waibel 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.
PubMed 31915048
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of the Surgical and Medical Management of Diabetic Foot Infections
- ClinicalTrials.gov ID
- NCT04081792
- Acronym / sponsor ID
- DFI_Cohort
- Keywords
- diabetic foot; osteomyelitis; amputation; antibiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 643 participants (actual)
- Lead sponsor
- Balgrist University HospitalUniversity, hospital or other
- Study start
- 4 Sep 2019 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 9 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 1. Trial (Amputation) Soft tissue - short antibiotic arm | Experimental | Procedure: Antibiotic therapyThe 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 | Procedure: Antibiotic therapyThe 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 | Procedure: Antibiotic therapyThe 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 | Procedure: Antibiotic therapyThe 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 | Procedure: Antibiotic therapyThe 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 | Procedure: Antibiotic therapyThe 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 | Procedure: Antibiotic therapyThe 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 | Procedure: Antibiotic therapyThe control group consists of 6 weeks of post-debridement antibiotic therapy for non-amputated diabetic foot osteomyelitis. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antibiotic therapyPostoperative randomizations regarding the duration of systemic antibiotics | Procedure or surgery | 1. Trial (Amputation) Bone - long antibiotic arm, 1. Trial (Amputation) Bone - short antibiotic arm, 1. Trial (Amputation) Soft tissue - long antibiotic arm, 1. Trial (Amputation) Soft tissue - short antibiotic arm, 2. Trial (osteomyelitis) - long antibiotic arm, 2. Trial (osteomyelitis) - short antibiotic arm, 2. Trial (soft tissue infection) - long antibiotic arm, 2.Trial (soft tissue infection) - short antibiotic arm |
Primary outcome
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
6 secondary outcomes
Anatomical Amputation Level Determination by MRI
Time frame: At study entry, Day O
Rates of adverse events of antibiotic therapy
Time frame: Through study completion, at 2 months
Duration of wound healing time
Time frame: Through study completion, at 2 months
Numbers of Cost and resource reductions
Time frame: Through study completion, at 2 months
Scales of Patient's satisfaction
Time frame: Through study completion, at 2 months
Statistical evaluation of risk factors for failure of remission
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Background: PubMed 29508677Uckay 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.
- Background: PubMed 25015390Coster 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 publication: PubMed 31008367Rossel 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 publication: PubMed 30664029Uckay 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 publication: PubMed 30129109Gariani 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.
- Derived from this study: PubMed 41464652Zendeli 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.
- Derived from this study: PubMed 31915048Waibel 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.
- Individual participant dataSharing planned: Yes. not yet determined in detail
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilker Uçkay, PD MD study director
Balgrist University Hospital, Zurich, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antibiotic therapy in people with Diabetic Foot Infection and Surgical Wound, run by Balgrist University Hospital at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with a clinical and microbiological remission of treated infection at 2 months (time frame: Through study completion, at 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04081792, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025.