Diabetes MellitusPhase 4C H R O N O SNCT02123628
Antibiotic Treatment Duration for Non-Surgically-Treated Diabetic Foot Osteomyelitis
A Phase 4 study testing duration of the antibiotic therapy in people with Diabetes Mellitus, run by Tourcoing Hospital at 1 site in France.
Trial summary
The purpose of the study is to compare the efficacy and tolerance of 6- versus 12-week antibiotic therapy in patients with diabetic foot osteomyelitis treated medically. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- duration of the antibiotic therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2007to Sep 2012
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diabetic patients treated non-surgically (i.e. without amputation or resection of the infected bone) for an osteomyelitis of the foot complicating a neuropathic foot without ischemia of the foot defined as the absence of any pedal pulse. Patients aged of 18 years or more were included if they had type 2 diabetes and osteomyelitis of the foot (i.e.below the ankle).
Who cannot join
- Patients with gangrene or who require bone resection or amputation when osteomyelitis of the foot was diagnosed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Six- Versus Twelve-Week Therapy for Non-Surgically-Treated Diabetic Foot Osteomyelitis: A Multicenter Open-Label Controlled Randomized Study
The purpose of the study is to compare the efficacy and tolerance of 6- versus 12-week antibiotic therapy in patients with diabetic foot osteomyelitis treated medically.
Read the detailed description
The aim of this randomized multicenter clinical study is to compare the efficacy and tolerance of 6 versus 12-week antibiotic treatment in patients with diabetic foot osteomyelitis treated medically as no equivalent data are currenty available in the literature.
- Conditions
- Diabetes Mellitus
- Being tested
- duration of the antibiotic therapy
- Keywords
- diabetic foot osteomyelitis, antibiotic treatment duration
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
duration of the antibiotic therapyDrug
Also called - Rifampin, - Levofloxacin, - Doxycycline, - Trimethoprim- sulfamethoxazole
| Study group | Role | What they receive |
|---|---|---|
| antibiotic therapy | Active comparator | patients are treated with a 6 week-duration of antibiotic therapy :
* Rifampin IP and PO twice daily, 10mg/kg /12H
* Levofloxacin IV and PO 500-750mg once daily
* Doxycycline PO 200mg once daily
* Trimethoprim- sulfamethoxazole IV and PO 800/160mg thrice daily
* Fusidic acid PO 500mg twice daily
* Linezolid IV and PO 600mg twice daily
* Ciprofloxacin IV and PO 750to 1000mg/12h
* Cefotaxime IV 100mg/kg in three IV infusions daily
* Ceftriaxone IV,intramuscularly or subcutaneously 2g once daily
* Cefepime IV ou intra-muscularly 2g /8-12h Receives: Drug: duration of the antibiotic therapy |
| 12 week-duration of antibiotic therapy | Active comparator | patients are treated with a 12 week-duration of antibiotic therapy :
* Rifampin IP and PO twice daily, 10mg/kg /12H
* Levofloxacin IV and PO 500-750mg once daily
* Doxycycline PO 200mg once daily
* Trimethoprim- sulfamethoxazole IV and PO 800/160mg thrice daily
* Fusidic acid PO 500mg twice daily
* Linezolid IV and PO 600mg twice daily
* Ciprofloxacin IV and PO 750to 1000mg/12h
* Cefotaxime IV 100mg/kg in three IV infusions daily
* Ceftriaxone IV,intramuscularly or subcutaneously 2g once daily
* Cefepime IV ou intra-muscularly 2g /8-12h Receives: Drug: duration of the antibiotic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome measure was the proportion of patients of each group with remission of diabetic foot osteomyelitis at the end of follow-up.
Remission was defined as the absence of any sign of infection at the initial or a contiguous site, evaluated at least one year after the end of antibiotic treatment (ie at the end of follow-up), with neither a new infectious episode nor the need for orthopedic surgery of the foot at either of these sites during the treatment and follow-up period.
Measured: one year
Secondary outcomes (1)
tolerance to treatment in each group of patients
number of episodes of adverse events attributable to the antibiotic treatment recorded in each group of patients.
Measured: 6 or 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2014 (estimated)
- Study startJun 2007
- Primary completionJun 2010
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tourcoing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric M Senneville, MD, PhD, Study director, Dron Hospital of Tourcoing FranceAlina Tone, MD, Principal investigator, Dron Hospital Tourcoing France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02123628
- Sponsor's protocol ID
- 2006-00625-14
- Acronym
- C H R O N O S
- Status last verified
- Apr 2014
- First submitted
- 15 Apr 2014
- Last updated
- 25 Apr 2014
- Results posted
- No
- Data monitoring committee
- 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 Feb;38(2):302-7. doi: 10.2337/dc14-1514. Epub 2014 Nov 20.
PubMed 25414157
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Six- Versus Twelve-Week Therapy for Non-Surgically-Treated Diabetic Foot Osteomyelitis: A Multicenter Open-Label Controlled Randomized Study
- ClinicalTrials.gov ID
- NCT02123628
- Acronym / sponsor ID
- C H R O N O S / 2006-00625-14
- Conditions
- Diabetes Mellitus
- Keywords
- diabetic foot osteomyelitis, antibiotic treatment duration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Tourcoing HospitalUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Jun 2010 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 25 Apr 2014 (estimated)
- 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.
The purpose of the study is to compare the efficacy and tolerance of 6- versus 12-week antibiotic therapy in patients with diabetic foot osteomyelitis treated medically.
Detailed description
The aim of this randomized multicenter clinical study is to compare the efficacy and tolerance of 6 versus 12-week antibiotic treatment in patients with diabetic foot osteomyelitis treated medically as no equivalent data are currenty available in the literature.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| antibiotic therapy | Active comparator | Drug: duration of the antibiotic therapypatients are treated with a 6 week-duration of antibiotic therapy : * Rifampin IP and PO twice daily, 10mg/kg /12H * Levofloxacin IV and PO 500-750mg once daily * Doxycycline PO 200mg once daily * Trimethoprim- sulfamethoxazole IV and PO 800/160mg thrice daily * Fusidic acid PO 500mg twice daily * Linezolid IV and PO 600mg twice daily * Ciprofloxacin IV and PO 750to 1000mg/12h * Cefotaxime IV 100mg/kg in three IV infusions daily * Ceftriaxone IV,intramuscularly or subcutaneously 2g once daily * Cefepime IV ou intra-muscularly 2g /8-12h |
| 12 week-duration of antibiotic therapy | Active comparator | Drug: duration of the antibiotic therapypatients are treated with a 12 week-duration of antibiotic therapy : * Rifampin IP and PO twice daily, 10mg/kg /12H * Levofloxacin IV and PO 500-750mg once daily * Doxycycline PO 200mg once daily * Trimethoprim- sulfamethoxazole IV and PO 800/160mg thrice daily * Fusidic acid PO 500mg twice daily * Linezolid IV and PO 600mg twice daily * Ciprofloxacin IV and PO 750to 1000mg/12h * Cefotaxime IV 100mg/kg in three IV infusions daily * Ceftriaxone IV,intramuscularly or subcutaneously 2g once daily * Cefepime IV ou intra-muscularly 2g /8-12h |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diabetic patients treated non-surgically (i.e. without amputation or resection of the infected bone) for an osteomyelitis of the foot complicating a neuropathic foot without ischemia of the foot defined as the absence of any pedal pulse. Patients aged of 18 years or more were included if they had type 2 diabetes and osteomyelitis of the foot (i.e.below the ankle).
Key exclusion criteria (1 listed)
- Patients with gangrene or who require bone resection or amputation when osteomyelitis of the foot was diagnosed
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 |
|---|---|---|
| duration of the antibiotic therapyAlso: - Rifampin, - Levofloxacin, - Doxycycline, - Trimethoprim- sulfamethoxazole | Drug | 12 week-duration of antibiotic therapy, antibiotic therapy |
Primary outcome
Primary outcome measure was the proportion of patients of each group with remission of diabetic foot osteomyelitis at the end of follow-up.
Time frame: one year
Remission was defined as the absence of any sign of infection at the initial or a contiguous site, evaluated at least one year after the end of antibiotic treatment (ie at the end of follow-up), with neither a new infectious episode nor the need for orthopedic surgery of the foot at either of these sites during the treatment and follow-up period.
1 secondary outcome
tolerance to treatment in each group of patients
Time frame: 6 or 12 weeks
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 25 Apr 2014.
- Derived from this study: PubMed 25414157Tone 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 Feb;38(2):302-7. doi: 10.2337/dc14-1514. Epub 2014 Nov 20.
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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.
Eric M Senneville, MD, PhD study director
Dron Hospital of Tourcoing France
Alina Tone, MD principal investigator
Dron Hospital Tourcoing France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing duration of the antibiotic therapy in people with Diabetes Mellitus, run by Tourcoing Hospital at 1 site in France.
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 1 inclusion and 1 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 25 Apr 2014. 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 France. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Primary outcome measure was the proportion of patients of each group with remission of diabetic foot osteomyelitis at the end of follow-up. (time frame: one year). 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 NCT02123628, which also lists 1 linked publication.
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 25 Apr 2014; AzTrials last refreshed its copy on 7 Nov 2026.