White Blood Cell SPECT/CT and Diabetic Foot Osteomyelitis

NCT02927678 | Unknown

• 1 other identifier: 69HCL16_0597
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetic Foot Osteomyelitis

Keywords

Diabetic foot; Osteomyelitis; Antibiotic treatment; White Blood Cell SPECT/CT

Outcome Measures

Primary Outcomes (1)

• Rate of remission of osteomyelitis at one year after the cessation of antibiotic treatment, evaluated by white blood cell SPECT/CT (Single Photon Emission Computed Tomography/Computed Tomography).

  The outcome measure was reviewed by patient examination at least 12 months after completion of antibiotic treatment. A remission was defined by : * the absence of recurrent infection at the initial site * no need for surgical bone resection or amputation

  one year after the end of the antibiotic treatment

Secondary Outcomes (5)

• Rate of osteomyelitis remission at one year after a 6 weeks antibiotics duration, evaluated by white blood cell SPECT/CT

  one year after the end of the antibiotic treatment

• Sensibility ration of White Blood Cell SPECT/CT performed at the end of antibiotic treatment to predict the remission of osteomyelitis at one year.

  one year after the end of the antibiotic treatment

• Specificity ratio of White Blood Cell SPECT/CT performed at the end of antibiotic treatment to predict the remission of osteomyelitis at one year.

  one year after the end of the antibiotic treatment

• Positive predictive value of White Blood Cell SPECT/CT performed at the end of antibiotic treatment to predict the remission of osteomyelitis at one year.

  one year after the end of the antibiotic treatment

• Negative predictive value of White Blood Cell SPECT/CT performed at the end of antibiotic treatment to predict the remission of osteomyelitis at one year.

  one year after the end of the antibiotic treatment

Study Arms (1)

Diabetic patients with osteomyelitis

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

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

Interventions

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

Diabetic patients with osteomyelitis

Eligibility Criteria

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

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• \- Indication for acute surgical bone resection or amputation

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

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

Pierre-Bénite, 69495, France

RECRUITING

Related Publications (2)

• 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.

  PMID: 33660690 DERIVED

• 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.

  PMID: 28866726 DERIVED

MeSH Terms

Conditions

Diabetic Foot; Osteomyelitis

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Bone Diseases, Infectious; Infections; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Central Study Contacts

Julien Vouillarmet, MD

CONTACT

(4) 78 86 14 89; julien.vouillarmet@chu-lyon.fr

Study Design

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

Study Record Dates

• First Submitted: October 6, 2016
• First Posted: October 7, 2016
• Study Start: January 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: October 7, 2016

Record last verified: 2016-09

Locations

FR (1)