New Diagnostic Tool (MinION) for Identifying Microorganisms in Foot Wounds of Patients Living With Diabetic Foot Osteomyelitis

NCT07391995 | Recruiting

• 1 other identifier: NIMAO/2025-1/MM-01
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Diabetes Mellitus; Diabetes Complications; Diabetic Peripheral Neuropathy

Keywords

Foot Ulcer, Diabetic; Infection

Outcome Measures

Primary Outcomes (2)

• 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

  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

  12 months

Secondary Outcomes (9)

• Description of the bone microbiota of diabetic foot osteomyelitis using the MinION method

  12 months

• Description of the bone microbiota of diabetic foot osteomyelitis using the conventional method (MALDI-TOF)

  12 months

• New potentially pathogenic species in diabetic foot osteomyelitis in relation to wound progression.

  3 months

• New potentially pathogenic species in diabetic foot osteomyelitis in relation to wound progression.

  6 months

• New potentially pathogenic species in diabetic foot osteomyelitis in relation to wound progression.

  12 months

Other Outcomes (8)

• Gender of patients providing samples

  Baseline

• Age of patients providing samples

  Baseline

• Body mass index of patients providing samples

  Baseline

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

147 bone biopsies from 43 diabetic patients collected in the orthopedic surgery operating room

You may qualify if:

• N/A

You may not qualify if:

• N/A

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

Nîmes University Hospital

Nîmes, Gard, 30029, France

RECRUITING

Related Publications (16)

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  PMID: 32176444 BACKGROUND

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  PMID: 30155447 BACKGROUND

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  PMID: 34372789 BACKGROUND

• Manas 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.

  PMID: 32370639 BACKGROUND

• Macauley 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.

  PMID: 33113230 BACKGROUND

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  PMID: 37779323 BACKGROUND

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  PMID: 34690988 BACKGROUND

• Malone 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.

  PMID: 28669650 BACKGROUND

• Morsli 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.

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• Morsli 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.

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• Morsli 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.

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  PMID: 36087524 BACKGROUND

Related Links

• Link to IDF Diabetes Atlas

Biospecimen

Retention: SAMPLES WITH DNA

147 bone biopsies from 43 diabetic patients collected in the orthopaedic surgery operating theatre

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Complications; Diabetic Foot; Infections

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetic Neuropathies

Study Officials

• Adeline Dubois, Dr.

  Nîmes University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Madjid MORSLI, Dr.

CONTACT

+334 66 68 31 17; madjid.morsli@chu-nimes.fr

Anissa MEGZARI

CONTACT

0466684236; drc@chu-nimes.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: February 6, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 11, 2026

Record last verified: 2026-02

Locations

FR (1)