Diabetic FootNCT03615807
Less Infections for the Diabetic Foot
A study testing Surgical debridement (if needed), Microbiological sampling and Revascularisation (if needed). in people with Diabetic Foot, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
This is a randomized, unblinded, single-centre study. After eventual surgical debridement (not amputation), patients will be randomized to receive 1 of 2 targeted antibiotic regimens, in the ratio 1:1. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Diabetic Foot
- What is being tested?
- Surgical debridement (if needed), Microbiological sampling and Revascularisation (if needed).
- Type of treatment
- Medical device, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteSwitzerland
- Study dates
- 16 Feb 2017to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18
- Diabetes mellitus
- Diabetic Foot Infections
- Surgical intervention to remove all necrotic tissue or tenotomy.
- Osteomyelitis limited to bone contact or cortical lesions in X-ray.
Who cannot join
- Implanted device.
- More than 96 hours of systemic antibiotic therapy prior to inclusion
- Amputation
- Destructive osteomyelitis
- Concomitant infections requiring more than 14 days of antibiotic therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Study Comparing Different Durations of Antibiotic Treatment for Diabetic Foot Infections
This is a randomized, unblinded, single-centre study. After eventual surgical debridement (not amputation), patients will be randomized to receive 1 of 2 targeted antibiotic regimens, in the ratio 1:1.
For diabetic toe osteomyelitis, the patients will be randomized between a 3 and a 6 week's arm, for soft tissue infections between 10 and 20 days. The final assessments used in the primary efficacy analysis will be obtained at the test-of-cure (TOC) visit approximately 60 days after treatment is stopped.
Read the detailed description
Diabetic foot infections (DFI) are frequent and are associated with a high burden of morbidity, costs, recurrence risk or new episodes of infections. About two-third of recurrent DFI may reveal other microorganisms than in the previous period, suggesting new episodes of infection due to the underlying problem, and/or selection by prior antimicrobial therapy. Osteomyelitis in the diabetic toe is almost always established by contiguous spread of infection from a chronic ulcer. It occurs in up to 15% of patients with a diabetic foot ulcer and about 20% of all DFI (and over half of severe infections) involve bone at presentation. The severity of a diabetic foot infection is based on the local and systemic signs and symptoms of infection and has been categorically defined in the Infectious Disease Society of America guidelines for the "Diagnosis and Treatment of Diabetic Foot Infections" (IDSA guidelines).
Knowing the potential for poor outcomes, many clinicians have tended to treat DFIs with a long duration of antibiotic therapy, with many side effects, development and spreading of antibiotic resistance, and associated costs. Data from recent comparative trials has shown that 1-2 weeks is sufficient for most soft tissue infections, and 4 to 6 weeks appears adequate in those with (unresected) infected bone. Retrospective reviews over the past two decades have demonstrated that about two-thirds of selected patients with diabetic foot osteomyelitis can achieve remission with antibiotic therapy alone (i.e., without bone resection). One recent randomized trial found that treatment with only antibiotic therapy (given for 90 days) gave similar clinical outcomes to treatment with conservative surgery (removal only of the infected bone) along with just a short course of antibiotic therapy. Another randomized trial compared a 6-week against 12-week course of antibiotic therapy, without concomitant surgery, for diabetic foot osteomyelitis and also found similar outcomes.
Likewise, the optimal antibiotic duration for any skin and soft tissue infection is unknown. According to some databases of University of Geneva Hospitals, among 378 skin and soft tissue infections in 346, overall cure was achieved in 330 episodes (87%) after a median antibiotic administration of 15 days. In multivariate Cox regression analysis, duration of antibiotic therapy (HR 1.0, 95%CI 0.96-1.02) did not influence treatment failure among patients with positive MRSA carriage.
Our study intends to optimize the duration of antibiotic therapy in DFI; for skin and soft tissue infections as well as for diabetic toe osteomyelitis that is not amputated.
- Conditions
- Diabetic Foot
- Being tested
- Surgical debridement (if needed), Microbiological sampling, Revascularisation (if needed)., Off-loading, Patient's education and instructions
- Keywords
- diabetic foot infections, antibiotic reduction, osteomyelitis, soft tissue infections
- Medical subject headings
- Diabetic Foot, Osteomyelitis, Soft Tissue Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical debridement (if needed)Procedure or surgery
Surgical debridement
Microbiological samplingDiagnostic test
Microbiological sampling
Revascularisation (if needed).Procedure or surgery
Revascularisation (if needed).
Off-loadingDevice
Off-loading by Special shoes
Patient's education and instructionsBehavioural
Patient's education and instructions by specialized nurses
Wound debridementProcedure or surgery
Regular wound debridement by specialized nurses
Antibiotic durationDrug
Systemic antibiotic duration according to the study arms
| Study group | Role | What they receive |
|---|---|---|
| Short antibiotic arm | Experimental | 10 days for soft tissue infections 3 weeks for osteomyelitis Receives: Procedure: Surgical debridement (if needed); Diagnostic Test: Microbiological sampling; Procedure: Revascularisation (if needed).; Device: Off-loading; Behavioral: Patient's education and instructions; Procedure: Wound debridement; Drug: Antibiotic duration |
| Standard antibiotic arm | Active comparator | 20 days for soft tissue infections 6 weeks for osteomyelitis Receives: Procedure: Surgical debridement (if needed); Diagnostic Test: Microbiological sampling; Procedure: Revascularisation (if needed).; Device: Off-loading; Behavioral: Patient's education and instructions; Procedure: Wound debridement; Drug: Antibiotic duration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Clinical Failure
Visual and dichotomous evaluation regarding the numbers of clinical recurrence/failure
Measured: 30-60 days
Secondary outcomes (1)
Number of Participants Experiencing Adverse Events Related to the Antibiotic Therapy
Adverse events related to the antibiotic therapy.
Measured: 30-60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start16 Feb 2017
- Primary completion29 Feb 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- 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
- Model description
- Two prospected-randomized protocols
- Masking
- None (open label)
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilker Uckay, University Hospital, Geneva
- Investigators
- Ilker Uçkay, MD, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03615807
- Sponsor's protocol ID
- n° 2016-01008
- Status last verified
- Jun 2020
- First submitted
- 16 Jan 2017
- Last updated
- 9 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tone A, Nguyen S, Devemy F, Topolinski H, Valette M, Cazaubiel M, Fayard A, Beltrand E, Lemaire C, Senneville E. Six-week versus twelve-week antibiotic therapy for nonsurgically treated diabetic foot osteomyelitis: a multicenter open-label controlled randomized study. Diabetes Care 2015;38:302-307. Diabetes Care. 2015 Apr;38(4):735. doi: 10.2337/dc15-er04b. No abstract available.
PubMed 25805867Pham TT, Gariani K, Richard JC, Kressmann B, Jornayvaz FR, Philippe J, Lipsky BA, Uckay I. Moderate to Severe Soft Tissue Diabetic Foot Infections: A Randomized, Controlled, Pilot Trial of Post-debridement Antibiotic Treatment for 10 versus 20 days. Ann Surg. 2022 Aug 1;276(2):233-238. doi: 10.1097/SLA.0000000000005205. Epub 2021 Sep 15.
PubMed 35623048Gariani K, Pham TT, Kressmann B, Jornayvaz FR, Gastaldi G, Stafylakis D, Philippe J, Lipsky BA, Uckay L. Three Weeks Versus Six Weeks of Antibiotic Therapy for Diabetic Foot Osteomyelitis: A Prospective, Randomized, Noninferiority Pilot Trial. Clin Infect Dis. 2021 Oct 5;73(7):e1539-e1545. doi: 10.1093/cid/ciaa1758.
PubMed 33242083
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study Comparing Different Durations of Antibiotic Treatment for Diabetic Foot Infections
- ClinicalTrials.gov ID
- NCT03615807
- Acronym / sponsor ID
- n° 2016-01008
- Conditions
- Diabetic Foot
- Keywords
- diabetic foot infections, antibiotic reduction, osteomyelitis, soft tissue infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 16 Feb 2017 (actual)
- Primary completion
- 29 Feb 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 6 Aug 2018 (actual)
- Results
- Posted 1 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, unblinded, single-centre study. After eventual surgical debridement (not amputation), patients will be randomized to receive 1 of 2 targeted antibiotic regimens, in the ratio 1:1.
For diabetic toe osteomyelitis, the patients will be randomized between a 3 and a 6 week's arm, for soft tissue infections between 10 and 20 days. The final assessments used in the primary efficacy analysis will be obtained at the test-of-cure (TOC) visit approximately 60 days after treatment is stopped.
Detailed description
Diabetic foot infections (DFI) are frequent and are associated with a high burden of morbidity, costs, recurrence risk or new episodes of infections. About two-third of recurrent DFI may reveal other microorganisms than in the previous period, suggesting new episodes of infection due to the underlying problem, and/or selection by prior antimicrobial therapy. Osteomyelitis in the diabetic toe is almost always established by contiguous spread of infection from a chronic ulcer. It occurs in up to 15% of patients with a diabetic foot ulcer and about 20% of all DFI (and over half of severe infections) involve bone at presentation. The severity of a diabetic foot infection is based on the local and systemic signs and symptoms of infection and has been categorically defined in the Infectious Disease Society of America guidelines for the "Diagnosis and Treatment of Diabetic Foot Infections" (IDSA guidelines).
Knowing the potential for poor outcomes, many clinicians have tended to treat DFIs with a long duration of antibiotic therapy, with many side effects, development and spreading of antibiotic resistance, and associated costs. Data from recent comparative trials has shown that 1-2 weeks is sufficient for most soft tissue infections, and 4 to 6 weeks appears adequate in those with (unresected) infected bone. Retrospective reviews over the past two decades have demonstrated that about two-thirds of selected patients with diabetic foot osteomyelitis can achieve remission with antibiotic therapy alone (i.e., without bone resection). One recent randomized trial found that treatment with only antibiotic therapy (given for 90 days) gave similar clinical outcomes to treatment with conservative surgery (removal only of the infected bone) along with just a short course of antibiotic therapy. Another randomized trial compared a 6-week against 12-week course of antibiotic therapy, without concomitant surgery, for diabetic foot osteomyelitis and also found similar outcomes.
Likewise, the optimal antibiotic duration for any skin and soft tissue infection is unknown. According to some databases of University of Geneva Hospitals, among 378 skin and soft tissue infections in 346, overall cure was achieved in 330 episodes (87%) after a median antibiotic administration of 15 days. In multivariate Cox regression analysis, duration of antibiotic therapy (HR 1.0, 95%CI 0.96-1.02) did not influence treatment failure among patients with positive MRSA carriage.
Our study intends to optimize the duration of antibiotic therapy in DFI; for skin and soft tissue infections as well as for diabetic toe osteomyelitis that is not amputated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two prospected-randomized protocols
| Arm | Type | Receives |
|---|---|---|
| Short antibiotic arm | Experimental | Procedure: Surgical debridement (if needed), Diagnostic Test: Microbiological sampling, Procedure: Revascularisation (if needed)., Device: Off-loading, Behavioral: Patient's education and instructions, Procedure: Wound debridement, Drug: Antibiotic duration10 days for soft tissue infections 3 weeks for osteomyelitis |
| Standard antibiotic arm | Active comparator | Procedure: Surgical debridement (if needed), Diagnostic Test: Microbiological sampling, Procedure: Revascularisation (if needed)., Device: Off-loading, Behavioral: Patient's education and instructions, Procedure: Wound debridement, Drug: Antibiotic duration20 days for soft tissue infections 6 weeks for osteomyelitis |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18
- Diabetes mellitus
- Diabetic Foot Infections
- Surgical intervention to remove all necrotic tissue or tenotomy.
- Osteomyelitis limited to bone contact or cortical lesions in X-ray.
Key exclusion criteria (5 listed)
- Implanted device.
- More than 96 hours of systemic antibiotic therapy prior to inclusion
- Amputation
- Destructive osteomyelitis
- Concomitant infections requiring more than 14 days of antibiotic therapy.
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 |
|---|---|---|
| Surgical debridement (if needed)Surgical debridement | Procedure or surgery | Short antibiotic arm, Standard antibiotic arm |
| Microbiological samplingMicrobiological sampling | Diagnostic test | Short antibiotic arm, Standard antibiotic arm |
| Revascularisation (if needed).Revascularisation (if needed). | Procedure or surgery | Short antibiotic arm, Standard antibiotic arm |
| Off-loadingOff-loading by Special shoes | Device | Short antibiotic arm, Standard antibiotic arm |
| Patient's education and instructionsPatient's education and instructions by specialized nurses | Behavioural | Short antibiotic arm, Standard antibiotic arm |
| Wound debridementRegular wound debridement by specialized nurses | Procedure or surgery | Short antibiotic arm, Standard antibiotic arm |
| Antibiotic durationSystemic antibiotic duration according to the study arms | Drug | Short antibiotic arm, Standard antibiotic arm |
Primary outcome
Number of Participants Experiencing Clinical Failure
Time frame: 30-60 days
Visual and dichotomous evaluation regarding the numbers of clinical recurrence/failure
1 secondary outcome
Number of Participants Experiencing Adverse Events Related to the Antibiotic Therapy
Time frame: 30-60 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25805867Tone A, Nguyen S, Devemy F, Topolinski H, Valette M, Cazaubiel M, Fayard A, Beltrand E, Lemaire C, Senneville E. Six-week versus twelve-week antibiotic therapy for nonsurgically treated diabetic foot osteomyelitis: a multicenter open-label controlled randomized study. Diabetes Care 2015;38:302-307. Diabetes Care. 2015 Apr;38(4):735. doi: 10.2337/dc15-er04b. No abstract available.
- Derived from this study: PubMed 35623048Pham TT, Gariani K, Richard JC, Kressmann B, Jornayvaz FR, Philippe J, Lipsky BA, Uckay I. Moderate to Severe Soft Tissue Diabetic Foot Infections: A Randomized, Controlled, Pilot Trial of Post-debridement Antibiotic Treatment for 10 versus 20 days. Ann Surg. 2022 Aug 1;276(2):233-238. doi: 10.1097/SLA.0000000000005205. Epub 2021 Sep 15.
- Derived from this study: PubMed 33242083Gariani K, Pham TT, Kressmann B, Jornayvaz FR, Gastaldi G, Stafylakis D, Philippe J, Lipsky BA, Uckay L. Three Weeks Versus Six Weeks of Antibiotic Therapy for Diabetic Foot Osteomyelitis: A Prospective, Randomized, Noninferiority Pilot Trial. Clin Infect Dis. 2021 Oct 5;73(7):e1539-e1545. doi: 10.1093/cid/ciaa1758.
- Individual participant dataSharing planned: No
Related trials for Diabetic Foot
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
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, MD principal investigator
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical debridement (if needed), Microbiological sampling and Revascularisation (if needed). in people with Diabetic Foot, run by University Hospital, Geneva 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 5 inclusion and 5 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 9 Jun 2020. 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?
Yes. Results are posted in the registry (first posted 1 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Experiencing Clinical Failure (time frame: 30-60 days). 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 NCT03615807, which also lists 3 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 9 Jun 2020.