White Blood Cell SPECT/CT and Diabetic Foot Osteomyelitis

NCT ID: NCT02927678

Last Updated: 2016-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

56 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-12-31

Brief Summary

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Osteomyelitis is a risk factor for lower extremity amputation in diabetic people. Antibiotic therapy allows a remission in 60 to 80% of cases. However the optimal duration of antibiotic therapy remains controversy due to the absence of validated marker of osteomyelitis remission. We have previously shown that the negativity of white blood cell SPECT/CT (Single Photon Emission Computed Tomography/Computed Tomography) imaging at the end of treatment allowed to predict remission of osteomyelitis at 1 year in all cases. A positive imaging was associated with recurrence in 70% of cases. The aim of our study was to evaluate prospectively the interest of white blood cell SPECT/CT to set the duration of antibiotic therapy.

Detailed Description

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Conditions

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Diabetic Foot Osteomyelitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Diabetic patients with osteomyelitis

Patients with a clinical and radiological diagnosis of osteomyelitis were included in two diabetic centers

white blood cell SPECT/CT (Single Photon Emission Computed Tomography/Computed Tomography) imaging

Intervention Type OTHER

Interventions

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white blood cell SPECT/CT (Single Photon Emission Computed Tomography/Computed Tomography) imaging

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age \>18 years
* Diabetes
* Osteomyelitis defined by soft tissue infection and/or positive probe-to-bone test and suggestive signs of osteomyelitis on plain-X-Ray

Exclusion Criteria

\- Indication for acute surgical bone resection or amputation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Service d'Endocrinologie-Diabétologie-Maladies de la nutrition, GH Sud, Hospices Civils de Lyon

Pierre-Bénite, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Julien Vouillarmet, MD

Role: CONTACT

(4) 78 86 14 89 ext. +33

References

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Vouillarmet J, Tordo J, Moret M, Michon P, Morelec I. 99mTc-white blood cell SPECT/CT to assess diabetic foot osteomyelitis remission: contribution of semi-quantitative scoring system. Nucl Med Commun. 2021 Jul 1;42(7):713-718. doi: 10.1097/MNM.0000000000001390.

Reference Type DERIVED
PMID: 33660690 (View on PubMed)

Vouillarmet J, Moret M, Morelec I, Michon P, Dubreuil J. Application of white blood cell SPECT/CT to predict remission after a 6 or 12 week course of antibiotic treatment for diabetic foot osteomyelitis. Diabetologia. 2017 Dec;60(12):2486-2494. doi: 10.1007/s00125-017-4417-x. Epub 2017 Sep 2.

Reference Type DERIVED
PMID: 28866726 (View on PubMed)

Other Identifiers

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69HCL16_0597

Identifier Type: -

Identifier Source: org_study_id

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