Diabetes MellitusMINI-OSNCT07391995
New Diagnostic Tool (MinION) for Identifying Microorganisms in Foot Wounds of Patients Living With Diabetic Foot Osteomyelitis
An observational study of Diabetes Mellitus and Diabetes Complications, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
Diabetic foot wound infections are predominantly polymicrobial. However, 'conventional' microbiological culture does not identify all the bacteria potentially involved in these infections and requires time, which can have a negative impact by delaying treatment and/or the prescription of appropriate antibiotic… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Mellitus, Diabetes Complications, Diabetic Peripheral Neuropathy
- How many people
- 43 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2026to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 147 bone biopsies from 43 diabetic patients collected in the orthopedic surgery operating room
Who may be able to join
- N/A
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Nîmes University Hospital
Nîmes, Gard, 30029
Madjid MORSLI, Dr., +33 04 66 68 31 17, madjid.morsli@chu-nimes.fr
Anissa MEGZARI, +33 04 66 68 42 36, drc@chu-nimes.fr
About this study
Official title: Evaluation of a New Diagnostic Tool (MinION) for Identifying Microorganisms in the Foot Wounds of Patients Living With Diabetic Foot Osteomyelitis (DFOM)
Diabetic foot wound infections are predominantly polymicrobial. However, 'conventional' microbiological culture does not identify all the bacteria potentially involved in these infections and requires time, which can have a negative impact by delaying treatment and/or the prescription of appropriate antibiotic therapy.
Real-time metagenomics analysis using Oxford Nanopore Technologies' MinION technology has demonstrated sufficient power to identify virtually all microbial genomes in a given sample, providing additional information on their antibiotic resistance profile and in silico prediction of genes encoding virulence factors within than 4 hours. Based on these rapid results, a management protocol could be defined specifically for each patient with a view to personalised medicine.
The aim is to study the diversity of bacterial and fungal species identified using the MinION method and compare this diversity with the results obtained using conventional methods (routine culture) from bone biopsies taken from DFOM patients.
Read the detailed description
Diabetes mellitus is one of the most common diseases in the world. Among its complications, 34% of patients living with diabetes will develop foot ulcers during their lifetime. Once this lesion has developed due to triopathy (arteriopathy, neuropathy, immunopathy), over 50% of these wounds will become infected, leading to serious consequences: bone damage (60 to 80% of cases), amputation (20% of infected wounds), mortality (68% at 5 years) and morbidity. The additional costs associated with this condition exceed $850 billion worldwide, with $1 million spent every 30 seconds due to complications from these wounds in the US. Diabetic foot ulcers (DFUs) are therefore a major public health problem.
For infectious disease specialists, one of the main difficulties in treating infections in these wounds is distinguishing between bacterial colonization - a physiological process, and infection - a pathological process. Studies of the microbiota of foot wounds in diabetic patients show the polymicrobial nature of these lesions, which contain commensal bacteria from the skin microbiota, opportunistic pathogenic bacteria and bacteria from the environment. Among Gram-positive cocci, Staphylococcus aureus is the species most often identified in diabetic foot osteomyelitis (DFO) (23.4%), followed by Pseudomonas spp. (11.1%), Escherichia coli (11.5%), Proteus spp. (8.3%), Klebsiella spp. (6.9%), and Enterococcus spp. (5.4%). Coagulase-negative staphylococci, although involved in less than 4% of infections, often remain difficult to identify by mass spectrometry at species level, even though some of them are known for their pathogenicity. The other major difficulty is the time it takes to obtain results when osteomyelitis is suspected. In such situations, obtaining a bone sample is the standard method and the best way to identify the pathogen(s) responsible and their sensitivity to antibiotics. Bone biopsy can be performed intraoperatively or percutaneously, as recommended by the International Working Group of the Diabetic Foot (IWGDF) in 2023. In addition, to avoid false-negative cultures, experts suggest delaying bone biopsy in patients already on antibiotics, ideally for at least two weeks. In the microbiology laboratory, the standard diagnosis based on conventional microbiological culture can take up to two weeks to identify the causative bacteria and perform antibiotic susceptibility testing on the responsible pathogen(s), bringing the total time to establish a diagnosis to 4 weeks.To reduce this delay, certain culture-free molecular microbiology techniques, in particular metagenomic next-generation sequencing (mNGS), have shown that the microbiota of most wound infections is more diverse and abundant than that revealed by conventional culture methods. However, very few metagenomic data on bone biopsies from DFOMs are available. As molecular biology tools were unable to distinguish between live and dead bacterial cells and cannot identify the bacterial genera contributing to the clinical status of the infection, their use in daily practice is not recommended by the IWGDF and SPILF (Société de Pathologie Infectieuse de Langue Française), as their results could lead to the unnecessary use of broad-spectrum antibiotics. Recent studies based on metagenomic analysis of bone biopsies, soft tissue biopsies and swabs from foot wounds in diabetic patients have identified microbial diversity as a marker of infection. The number of bacteria involved in confirmed cases of infection is estimated at over 70, a figure difficult to achieve with conventional routine methods. The use of PCR based on amplification of the gene coding for 16S rRNA is considered unsuitable due to the frequent polymicrobial nature of DFOM samples. Multiplex PCR methods are not exhaustive in identifying all pathogens. Finally, conventional culture methods are often time-consuming, and species identification using laboratory methods such as MALDI-TOF mass spectrometry is often a source of confusion or failure. Recently, a new rapid sequencing tool has been developed: the MinION. It is small and fast and can sequence a bacterial or viral genome from single-microbe samples in less than four hours, or determine a panel of microorganisms present in a more complex sample. This tool is particularly useful for cerebrospinal fluid.
- Keywords
- Foot Ulcer, Diabetic, Infection
- Medical subject headings
- Diabetes Mellitus, Diabetes Complications, Diabetic Foot, Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of bacterial and fungal species found in a conventional bone biopsy
Number of species found by each method (presence/absence and species identification): bacterial and fungal species detected in bone biopsies by the two methods (conventional culture vs MinION
Measured: 12 months
Number of bacterial and fungal species found with the MiniON device
Number of species found by each method (presence/absence and species identification): bacterial and fungal species detected in bone biopsies by the two methods (conventional culture vs MinION
Measured: 12 months
Secondary outcomes (9)
Description of the bone microbiota of diabetic foot osteomyelitis using the MinION method
Typology of microbial species found using the MinION method. The MinION™ Mk1D is the next generation of portable nanopore sequencing devices. Improved thermal dissipation capabilities of the MinION Mk1D significantly enhances sequencing performance, enabling highly accurate real-time sequencing in an even wider range of environments than its predecessor, the MinION Mk1B.
Measured: 12 months
Description of the bone microbiota of diabetic foot osteomyelitis using the conventional method (MALDI-TOF)
Typology of microbial species found using the MALDI-TOF method. The MALDI-TOF (Matrix Assisted Laser Desorption Ionization - Time of Flight) instrument is a mass spectrometer that combines a matrix-assisted laser ionization source (MALDI) with a time-of-flight analyzer (TOF). One of the important characteristics of mass spectrometry is peak sharpness, measured by the resolution of the mass spectrometer. Resolution is defined as the ratio of the peak mass m to the full width at half maximum Δm. The higher the resolution, the sharper the peaks. This makes it possible to visualize two molecules with similar masses. MALDI-TOF instruments can be equipped with a reflection (electrostatic mirror or "ion mirror") that deflects ions with an electric field, thereby doubling the length of the ion flight path and increasing the resolution of the instrument. A MALDI-TOF mass spectrometer can achieve resolutions of 5000 in linear mode (without reflection) and 20000 with reflecton.
Measured: 12 months
New potentially pathogenic species in diabetic foot osteomyelitis in relation to wound progression.
Degree of wound healing at 3 months, 6 months and one year, depending on the presence or absence of different microbial species.
Measured: 3 months
New potentially pathogenic species in diabetic foot osteomyelitis in relation to wound progression.
Degree of wound healing at 3 months, 6 months and one year, depending on the presence or absence of different microbial species.
Measured: 6 months
New potentially pathogenic species in diabetic foot osteomyelitis in relation to wound progression.
Degree of wound healing at 3 months, 6 months and one year, depending on the presence or absence of different microbial species.
Measured: 12 months
Antibiotic sensitivity profiles of microorganisms obtained in vitro (bacterial culture).
The number and % of strains resistant to antibiotics tested on pathogenic bacteria isolated in standard microbiological culture will be recorded.
Measured: 12 months
Antibiotic sensitivity profiles of microorganisms obtained in silico (MinION technology).
Presence/absence of resistance genes to the antibiotic families tested on pathogenic bacteria isolated in standard microbiological culture
Measured: 12 months
Cost of conventional in vitro culture and testing
Cost in Euros
Measured: 12 months
Cost of using in silico MinION technology
Cost in Euros
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start1 Jan 2026
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adeline Dubois, Dr., Principal investigator, Nîmes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07391995
- Sponsor's protocol ID
- NIMAO/2025-1/MM-01
- Acronym
- MINI-OS
- Status last verified
- Feb 2026
- First submitted
- 28 Jan 2026
- Last updated
- 11 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lipsky BA, Senneville E, Abbas ZG, Aragon-Sanchez J, Diggle M, Embil JM, Kono S, Lavery LA, Malone M, van Asten SA, Urbancic-Rovan V, Peters EJG; International Working Group on the Diabetic Foot (IWGDF). Guidelines on the diagnosis and treatment of foot infection in persons with diabetes (IWGDF 2019 update). Diabetes Metab Res Rev. 2020 Mar;36 Suppl 1:e3280. doi: 10.1002/dmrr.3280.
PubMed 32176444Cascini S, Agabiti N, Davoli M, Uccioli L, Meloni M, Giurato L, Marino C, Bargagli AM. Survival and factors predicting mortality after major and minor lower-extremity amputations among patients with diabetes: a population-based study using health information systems. BMJ Open Diabetes Res Care. 2020 Jul;8(1):e001355. doi: 10.1136/bmjdrc-2020-001355.
PubMed 32690575Armstrong DG, Kanda VA, Lavery LA, Marston W, Mills JL Sr, Boulton AJ. Mind the gap: disparity between research funding and costs of care for diabetic foot ulcers. Diabetes Care. 2013 Jul;36(7):1815-7. doi: 10.2337/dc12-2285. No abstract available.
PubMed 23801792Radzieta M, Sadeghpour-Heravi F, Peters TJ, Hu H, Vickery K, Jeffries T, Dickson HG, Schwarzer S, Jensen SO, Malone M. A multiomics approach to identify host-microbe alterations associated with infection severity in diabetic foot infections: a pilot study. NPJ Biofilms Microbiomes. 2021 Mar 22;7(1):29. doi: 10.1038/s41522-021-00202-x.
PubMed 33753735Jneid J, Cassir N, Schuldiner S, Jourdan N, Sotto A, Lavigne JP, La Scola B. Exploring the Microbiota of Diabetic Foot Infections With Culturomics. Front Cell Infect Microbiol. 2018 Aug 14;8:282. doi: 10.3389/fcimb.2018.00282. eCollection 2018.
PubMed 30155447Macdonald KE, Boeckh S, Stacey HJ, Jones JD. The microbiology of diabetic foot infections: a meta-analysis. BMC Infect Dis. 2021 Aug 9;21(1):770. doi: 10.1186/s12879-021-06516-7.
PubMed 34372789Manas AB, Taori S, Ahluwalia R, Slim H, Manu C, Rashid H, Kavarthapu V, Edmonds M, Vas PRJ. Admission Time Deep Swab Specimens Compared With Surgical Bone Sampling in Hospitalized Individuals With Diabetic Foot Osteomyelitis and Soft Tissue Infection. Int J Low Extrem Wounds. 2021 Dec;20(4):300-308. doi: 10.1177/1534734620916386. Epub 2020 May 5.
PubMed 32370639Macauley M, Adams G, Mackenny P, Kubelka I, Scott E, Buckworth R, Biddiscombe C, Aitkins C, Lake H, Matthews V, Ashraff S, Ashwell S. Microbiological evaluation of resection margins of the infected diabetic foot ulcer. Diabet Med. 2021 Apr;38(4):e14440. doi: 10.1111/dme.14440. Epub 2020 Nov 11.
PubMed 33113230Senneville E, Albalawi Z, van Asten SA, Abbas ZG, Allison G, Aragon-Sanchez J, Embil JM, Lavery LA, Alhasan M, Oz O, Uckay I, Urbancic-Rovan V, Xu ZR, Peters EJG. IWGDF/IDSA guidelines on the diagnosis and treatment of diabetes-related foot infections (IWGDF/IDSA 2023). Diabetes Metab Res Rev. 2024 Mar;40(3):e3687. doi: 10.1002/dmrr.3687. Epub 2023 Oct 1.
PubMed 37779323Chen Y, Shi Y, Zhu W, You J, Yang J, Xie Y, Zhao H, Li H, Fan S, Li L, Liu C. Combining CRISPR-Cas12a-Based Technology and Metagenomics Next Generation Sequencing: A New Paradigm for Rapid and Full-Scale Detection of Microbes in Infectious Diabetic Foot Samples. Front Microbiol. 2021 Oct 7;12:742040. doi: 10.3389/fmicb.2021.742040. eCollection 2021.
PubMed 34690988Malone M, Johani K, Jensen SO, Gosbell IB, Dickson HG, Hu H, Vickery K. Next Generation DNA Sequencing of Tissues from Infected Diabetic Foot Ulcers. EBioMedicine. 2017 Jul;21:142-149. doi: 10.1016/j.ebiom.2017.06.026. Epub 2017 Jun 27.
PubMed 28669650Morsli M, Salipante F, Magnan C, Dunyach-Remy C, Sotto A, Lavigne JP. Direct metagenomics investigation of non-surgical hard-to-heal wounds: a review. Ann Clin Microbiol Antimicrob. 2024 May 3;23(1):39. doi: 10.1186/s12941-024-00698-z.
PubMed 38702796Eshaghi A, Bommersbach C, Zittermann S, Burnham CA, Patel R, Schuetz AN, Patel SN, Kus JV. Phenotypic and Genomic Profiling of Staphylococcus argenteus in Canada and the United States and Recommendations for Clinical Result Reporting. J Clin Microbiol. 2021 May 19;59(6):e02470-20. doi: 10.1128/JCM.02470-20. Print 2021 May 19.
PubMed 33731414Morsli M, Bechah Y, Coulibaly O, Toro A, Fournier PE, Houhamdi L, Drancourt M. Direct diagnosis of Pasteurella multocida meningitis using next-generation sequencing. Lancet Microbe. 2022 Jan;3(1):e6. doi: 10.1016/S2666-5247(21)00277-9. Epub 2021 Nov 11. No abstract available.
PubMed 35544115Morsli M, Kerharo Q, Amrane S, Parola P, Fournier PE, Drancourt M. Real-time whole genome sequencing direct diagnosis of Streptococcus pneumoniae meningitis: A case report. J Infect. 2021 Dec;83(6):709-737. doi: 10.1016/j.jinf.2021.10.002. Epub 2021 Oct 8. No abstract available.
PubMed 34627841
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a New Diagnostic Tool (MinION) for Identifying Microorganisms in the Foot Wounds of Patients Living With Diabetic Foot Osteomyelitis (DFOM)
- ClinicalTrials.gov ID
- NCT07391995
- Acronym / sponsor ID
- MINI-OS / NIMAO/2025-1/MM-01
- Keywords
- Foot Ulcer, Diabetic, Infection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 6 Feb 2026 (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 wound infections are predominantly polymicrobial. However, 'conventional' microbiological culture does not identify all the bacteria potentially involved in these infections and requires time, which can have a negative impact by delaying treatment and/or the prescription of appropriate antibiotic therapy.
Real-time metagenomics analysis using Oxford Nanopore Technologies' MinION technology has demonstrated sufficient power to identify virtually all microbial genomes in a given sample, providing additional information on their antibiotic resistance profile and in silico prediction of genes encoding virulence factors within than 4 hours. Based on these rapid results, a management protocol could be defined specifically for each patient with a view to personalised medicine.
The aim is to study the diversity of bacterial and fungal species identified using the MinION method and compare this diversity with the results obtained using conventional methods (routine culture) from bone biopsies taken from DFOM patients.
Detailed description
Diabetes mellitus is one of the most common diseases in the world. Among its complications, 34% of patients living with diabetes will develop foot ulcers during their lifetime. Once this lesion has developed due to triopathy (arteriopathy, neuropathy, immunopathy), over 50% of these wounds will become infected, leading to serious consequences: bone damage (60 to 80% of cases), amputation (20% of infected wounds), mortality (68% at 5 years) and morbidity. The additional costs associated with this condition exceed $850 billion worldwide, with $1 million spent every 30 seconds due to complications from these wounds in the US. Diabetic foot ulcers (DFUs) are therefore a major public health problem.
For infectious disease specialists, one of the main difficulties in treating infections in these wounds is distinguishing between bacterial colonization - a physiological process, and infection - a pathological process. Studies of the microbiota of foot wounds in diabetic patients show the polymicrobial nature of these lesions, which contain commensal bacteria from the skin microbiota, opportunistic pathogenic bacteria and bacteria from the environment. Among Gram-positive cocci, Staphylococcus aureus is the species most often identified in diabetic foot osteomyelitis (DFO) (23.4%), followed by Pseudomonas spp. (11.1%), Escherichia coli (11.5%), Proteus spp. (8.3%), Klebsiella spp. (6.9%), and Enterococcus spp. (5.4%). Coagulase-negative staphylococci, although involved in less than 4% of infections, often remain difficult to identify by mass spectrometry at species level, even though some of them are known for their pathogenicity. The other major difficulty is the time it takes to obtain results when osteomyelitis is suspected. In such situations, obtaining a bone sample is the standard method and the best way to identify the pathogen(s) responsible and their sensitivity to antibiotics. Bone biopsy can be performed intraoperatively or percutaneously, as recommended by the International Working Group of the Diabetic Foot (IWGDF) in 2023. In addition, to avoid false-negative cultures, experts suggest delaying bone biopsy in patients already on antibiotics, ideally for at least two weeks. In the microbiology laboratory, the standard diagnosis based on conventional microbiological culture can take up to two weeks to identify the causative bacteria and perform antibiotic susceptibility testing on the responsible pathogen(s), bringing the total time to establish a diagnosis to 4 weeks.To reduce this delay, certain culture-free molecular microbiology techniques, in particular metagenomic next-generation sequencing (mNGS), have shown that the microbiota of most wound infections is more diverse and abundant than that revealed by conventional culture methods. However, very few metagenomic data on bone biopsies from DFOMs are available. As molecular biology tools were unable to distinguish between live and dead bacterial cells and cannot identify the bacterial genera contributing to the clinical status of the infection, their use in daily practice is not recommended by the IWGDF and SPILF (Société de Pathologie Infectieuse de Langue Française), as their results could lead to the unnecessary use of broad-spectrum antibiotics. Recent studies based on metagenomic analysis of bone biopsies, soft tissue biopsies and swabs from foot wounds in diabetic patients have identified microbial diversity as a marker of infection. The number of bacteria involved in confirmed cases of infection is estimated at over 70, a figure difficult to achieve with conventional routine methods. The use of PCR based on amplification of the gene coding for 16S rRNA is considered unsuitable due to the frequent polymicrobial nature of DFOM samples. Multiplex PCR methods are not exhaustive in identifying all pathogens. Finally, conventional culture methods are often time-consuming, and species identification using laboratory methods such as MALDI-TOF mass spectrometry is often a source of confusion or failure. Recently, a new rapid sequencing tool has been developed: the MinION. It is small and fast and can sequence a bacterial or viral genome from single-microbe samples in less than four hours, or determine a panel of microorganisms present in a more complex sample. This tool is particularly useful for cerebrospinal fluid.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 147 bone biopsies from 43 diabetic patients collected in the orthopedic surgery operating room
Key inclusion criteria (1 listed)
- N/A
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of bacterial and fungal species found in a conventional bone biopsy
Time frame: 12 months
Number of species found by each method (presence/absence and species identification): bacterial and fungal species detected in bone biopsies by the two methods (conventional culture vs MinION
Number of bacterial and fungal species found with the MiniON device
Time frame: 12 months
Number of species found by each method (presence/absence and species identification): bacterial and fungal species detected in bone biopsies by the two methods (conventional culture vs MinION
9 secondary outcomes
Description of the bone microbiota of diabetic foot osteomyelitis using the MinION method
Time frame: 12 months
Description of the bone microbiota of diabetic foot osteomyelitis using the conventional method (MALDI-TOF)
Time frame: 12 months
New potentially pathogenic species in diabetic foot osteomyelitis in relation to wound progression.
Time frame: 3 months
New potentially pathogenic species in diabetic foot osteomyelitis in relation to wound progression.
Time frame: 6 months
New potentially pathogenic species in diabetic foot osteomyelitis in relation to wound progression.
Time frame: 12 months
Antibiotic sensitivity profiles of microorganisms obtained in vitro (bacterial culture).
Time frame: 12 months
Antibiotic sensitivity profiles of microorganisms obtained in silico (MinION technology).
Time frame: 12 months
Cost of conventional in vitro culture and testing
Time frame: 12 months
Cost of using in silico MinION technology
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Background: PubMed 32176444Lipsky BA, Senneville E, Abbas ZG, Aragon-Sanchez J, Diggle M, Embil JM, Kono S, Lavery LA, Malone M, van Asten SA, Urbancic-Rovan V, Peters EJG; International Working Group on the Diabetic Foot (IWGDF). Guidelines on the diagnosis and treatment of foot infection in persons with diabetes (IWGDF 2019 update). Diabetes Metab Res Rev. 2020 Mar;36 Suppl 1:e3280. doi: 10.1002/dmrr.3280.
- Background: PubMed 32690575Cascini S, Agabiti N, Davoli M, Uccioli L, Meloni M, Giurato L, Marino C, Bargagli AM. Survival and factors predicting mortality after major and minor lower-extremity amputations among patients with diabetes: a population-based study using health information systems. BMJ Open Diabetes Res Care. 2020 Jul;8(1):e001355. doi: 10.1136/bmjdrc-2020-001355.
- Background: PubMed 23801792Armstrong DG, Kanda VA, Lavery LA, Marston W, Mills JL Sr, Boulton AJ. Mind the gap: disparity between research funding and costs of care for diabetic foot ulcers. Diabetes Care. 2013 Jul;36(7):1815-7. doi: 10.2337/dc12-2285. No abstract available.
- Background: PubMed 33753735Radzieta M, Sadeghpour-Heravi F, Peters TJ, Hu H, Vickery K, Jeffries T, Dickson HG, Schwarzer S, Jensen SO, Malone M. A multiomics approach to identify host-microbe alterations associated with infection severity in diabetic foot infections: a pilot study. NPJ Biofilms Microbiomes. 2021 Mar 22;7(1):29. doi: 10.1038/s41522-021-00202-x.
- Background: PubMed 30155447Jneid J, Cassir N, Schuldiner S, Jourdan N, Sotto A, Lavigne JP, La Scola B. Exploring the Microbiota of Diabetic Foot Infections With Culturomics. Front Cell Infect Microbiol. 2018 Aug 14;8:282. doi: 10.3389/fcimb.2018.00282. eCollection 2018.
- Background: PubMed 34372789Macdonald KE, Boeckh S, Stacey HJ, Jones JD. The microbiology of diabetic foot infections: a meta-analysis. BMC Infect Dis. 2021 Aug 9;21(1):770. doi: 10.1186/s12879-021-06516-7.
- Background: PubMed 32370639Manas AB, Taori S, Ahluwalia R, Slim H, Manu C, Rashid H, Kavarthapu V, Edmonds M, Vas PRJ. Admission Time Deep Swab Specimens Compared With Surgical Bone Sampling in Hospitalized Individuals With Diabetic Foot Osteomyelitis and Soft Tissue Infection. Int J Low Extrem Wounds. 2021 Dec;20(4):300-308. doi: 10.1177/1534734620916386. Epub 2020 May 5.
- Background: PubMed 33113230Macauley M, Adams G, Mackenny P, Kubelka I, Scott E, Buckworth R, Biddiscombe C, Aitkins C, Lake H, Matthews V, Ashraff S, Ashwell S. Microbiological evaluation of resection margins of the infected diabetic foot ulcer. Diabet Med. 2021 Apr;38(4):e14440. doi: 10.1111/dme.14440. Epub 2020 Nov 11.
- Background: PubMed 37779323Senneville E, Albalawi Z, van Asten SA, Abbas ZG, Allison G, Aragon-Sanchez J, Embil JM, Lavery LA, Alhasan M, Oz O, Uckay I, Urbancic-Rovan V, Xu ZR, Peters EJG. IWGDF/IDSA guidelines on the diagnosis and treatment of diabetes-related foot infections (IWGDF/IDSA 2023). Diabetes Metab Res Rev. 2024 Mar;40(3):e3687. doi: 10.1002/dmrr.3687. Epub 2023 Oct 1.
- Background: PubMed 34690988Chen Y, Shi Y, Zhu W, You J, Yang J, Xie Y, Zhao H, Li H, Fan S, Li L, Liu C. Combining CRISPR-Cas12a-Based Technology and Metagenomics Next Generation Sequencing: A New Paradigm for Rapid and Full-Scale Detection of Microbes in Infectious Diabetic Foot Samples. Front Microbiol. 2021 Oct 7;12:742040. doi: 10.3389/fmicb.2021.742040. eCollection 2021.
- Background: PubMed 28669650Malone M, Johani K, Jensen SO, Gosbell IB, Dickson HG, Hu H, Vickery K. Next Generation DNA Sequencing of Tissues from Infected Diabetic Foot Ulcers. EBioMedicine. 2017 Jul;21:142-149. doi: 10.1016/j.ebiom.2017.06.026. Epub 2017 Jun 27.
- Background: PubMed 38702796Morsli M, Salipante F, Magnan C, Dunyach-Remy C, Sotto A, Lavigne JP. Direct metagenomics investigation of non-surgical hard-to-heal wounds: a review. Ann Clin Microbiol Antimicrob. 2024 May 3;23(1):39. doi: 10.1186/s12941-024-00698-z.
- Link to IDF Diabetes AtlasLink provided by the sponsor.
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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.
Adeline Dubois, Dr. principal investigator
Nîmes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Diabetes Complications, run by Centre Hospitalier Universitaire de Nīmes 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: looking for participants now, as of the sponsor's last update on 11 Feb 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Madjid MORSLI, Dr. (+334 66 68 31 17, madjid.morsli@chu-nimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of bacterial and fungal species found in a conventional bone biopsy (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT07391995, which also lists 16 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 11 Feb 2026.