An observational study in Diabetes Mellitus and Foot Osteomyelitis, sponsored by University Hospital, Montpellier. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-06-05.
Sponsored by University Hospital, Montpellier · Observational
Bone samples from infected diabetic feet will be collected and tests will be performed for the diagnosis of causative bacteria. Samples will be processed by PCR multiplex tests and usual cultures for identification of causative bacteria and sensitivity to antibiotics. Results obtained by the two methods will be compared in terms of quickness and similarity of germ identification. Usual care strategy will not be modified since results of PCR multiplex tests will not be transmitted to the physicians before the results of usual cultures.
This study will investigate the quickness of identification of bacteria causing bone infection in the feet of patients with diabetes from bone samples obtained by biopsies performed in usaual care practice.
Bone biopsies will be performed in patients diagnosed for osteomyelitis from clinical, biological and MRI signs. Bone samples will be collected in Ultra-Turrax® tubes in the operating theater before being transferred to the department of bacteriology. Time of registration at the bacteriology lab will be considered as Time 0 (T0).
Samples will be processed simultaneously using the usual culture method and by PCR Multiplex tests.
The time of identification of causative bacteria for bone infection (time 1, T1) and the time of identification of sensitivity/resistance to antibiotics (time 2, T2) by the two different methods will be recorded.
Identified germs and their sensitivity/resistance to antibiotics according to the two methods will be compared.
If the results are similar, the time that could be gained for the prescription of specific antibiotics from PCR multiplex tests' results will be computed in comparison to the prescription performed from the results of usual cultures.
1,077 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's enrollment of 48 is below the median of 100 across 191 observational studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →University Hospital, Montpellier is the lead sponsor of 1,261 studies on the registry; 224 are open to participants now.
Compared within Diabetic Foot, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Diabetes Mellitus. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Diabetic patients admitted in hospital for foot osteomyelitis
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biological and MRI signs of foot osteomyelitis
Other: Bone sampling
Bone biopsy in Diabetic patients with foot osteomyelitis
Time for identification of bacteria responsible for foot osteomyelitis
The difference of time between usual cultures and PCR multiplex tests to identify responsible bacteria will be assessed
Time frame: 12-48 hours
Time for identification of sensitivity/resistance to antibiotics of the bacteria responsible for foot osteomyelitis
The difference of time between usual cultures and PCR multiplex tests to identify sensitivity/resistance to antibiotics of responsible bacteria for foot osteomyelitis will be assessed
Time frame: 12-96 hours
Plan to share: Undecided — NC
No publications or documents are linked to this record.
Ran from Feb 2018 to primary completion in Dec 2019, 21 months.
Of 65 non-industry observational studies under Diabetic Foot, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 94. This study's 21 months is below that.
Counting every sponsor, half of 90 studies reached it within 28 months; a quarter within 15 and three quarters within 59.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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University Hospital, Montpellier →