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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorCentre Hospitalier Universitaire de Nīmes

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

N/A

Disqualifiers

N/A

Trial population

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

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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

Time frame
12 months
2

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

Time frame
12 months

Secondary outcomes

1

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.

Time frame
12 months
2

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.

Time frame
12 months
3

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.

Time frame
3 months
4

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.

Time frame
6 months

Other outcomes

1

Gender of patients providing samples

Male/female/Non-binary

Time frame
Baseline
2

Age of patients providing samples

In years

Time frame
Baseline
3

Body mass index of patients providing samples

The formula is BMI = kg/m2; kg is a person's weight in kilograms and m2 is height in meters squared

Time frame
Baseline
4

Wound grade

Wagner Grade 1: Partial- or full-thickness ulcer (superficial ulcer) Wagner Grade 2: Deep ulcer extended to ligament, tendon, joint capsule, bone, or deep fascia without abscess or osteomyelitis (OM) Wagner Grade 3: Deep abscess, OM, or joint sepsis. Wagner Grade 4: Partial-foot gangrene.

Time frame
Baseline

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