UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022208 |
|---|---|
| Receipt number | R000009900 |
| Scientific Title | Quantative Evaluation of Osteomyelitis and Effectiveness of Hyperbaric Oxygen Therapy by SPECT-CT |
| Date of disclosure of the study information | 2016/06/01 |
| Last modified on | 2023/05/12 23:32:26 |
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Basic information
Public title
Quantative Evaluation of Osteomyelitis and Effectiveness of Hyperbaric Oxygen Therapy by SPECT-CT
Acronym
Evalation of Osteomyelitis and HBO by SPECT/CT
Scientific Title
Quantative Evaluation of Osteomyelitis and Effectiveness of Hyperbaric Oxygen Therapy by SPECT-CT
Scientific Title:Acronym
Evalation of Osteomyelitis and HBO by SPECT/CT
Region
| Japan |
Condition
Condition
Chronic osteomyelisis
Classification by specialty
| Cardiology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Presence of osteomyelitis may result in major limb amputation in patients with diabetes gangrene and/or refractory chronic ulcer caused by peripheral arterial disease (PAD). X-ray, computed tomography, magnetic resonance imaging and 67Ga-Citrate scintigraphy can all sometimes detect osteomyelitis, but none has become the standard. We use 67Ga-citrate hybrid SPECT-CT fusion imaging to determine exact locations and quantitative severity of osteomyelitis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Limb salvage
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with chronic foot ulcer, suspected complicating osteomyelitis
Key exclusion criteria
Patients whom hyperbaric oxygen therapy is contraindication
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Sonoko |
| Middle name | |
| Last name | KIrinoki-Ichikawa |
Organization
Nippon Medical School Hospital
Division name
Department of Cardiology
Zip code
113-8603
Address
1-1-5, Sendagi, Bunkyo-Ku, Tokyo, Japan
TEL
+81338222131
k-I-sonoko@nms.ac.jp
Public contact
Name of contact person
| 1st name | Sonoko |
| Middle name | |
| Last name | KIrinoki-Ichikawa |
Organization
Nippon Medical School Hospital
Division name
Department of Cardiology
Zip code
113-8603
Address
1-1-5, Sendagi, Bunkyo-Ku, Tokyo, Japan
TEL
+81338222131
Homepage URL
k-I-sonoko@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nippon Medical School
Address
1-1-5, BUnkyo-ku, Tokyo
Tel
03-3822-2131
k-i-sonoko@nms.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東京都
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/full/10.1111/wrr.13075
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/full/10.1111/wrr.13075
Number of participants that the trial has enrolled
90
Results
The aim of this study was to determine the indication for osteotomy in lower limb osteomyelitis by quantitative gallium-single photon emission computed tomography-CT. The rate of osteotomy was higher in patients with inflammation-to-background ratio (IBR) over 8.4 than in those with IBR less than 8.4. Multivariate Cox regression analysis showed that IBR over 8.4 was an independent risk factor for osteotomy.
Results date posted
| 2023 | Year | 05 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients who with at least one chronic disease (e.g., Type 2 diabetes, history of cardiovascular disease, limb ischemia, or requirement for haemodialysis) who developed foot ulcers or rest leg pain between January 2012 and July 2017.
Participant flow
This was the single-centre prospective diagnostic study. In the group of patients who were originally registered in the master registry of our prior study evaluating the effects of hyperbaric oxygen therapy, we recruited consecutive patients who with at least one chronic disease (e.g., Type 2 diabetes, history of cardiovascular disease, limb ischemia, or requirement for haemodialysis) who developed foot ulcers or rest leg pain between January 2012 and July 2017. Among them, patients with suspected lower limb ischemia were enrolled in the study.
Adverse events
No adverse events were reported.
Outcome measures
Initial osteotomy was the primary endpoint of the study. In this study, osteotomy meant partial removal of infected bone below the ankle joint and was distinguished from major limb amputation such as below-knee or above-knee amputation. Patients underwent outpatient observation at the same hospital for more than 5 years after the first 67Ga-SPECT/CT examination.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2011 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
67Ga-citrate hybrid SPECT-CT will be performed to patients who are suspected having osteomyelitis, Pre- and Post-Target to Background Ratio (TBR; the accumulation at osteomyelitis site divided by that at normal distal end of the femur will be compared. The obtained data will show us the threshold whether the osteomyelitis site should be surgically removed or conservative treatment would work.
Management information
Registered date
| 2016 | Year | 05 | Month | 05 | Day |
Last modified on
| 2023 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009900
