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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000022208
Receipt No. 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 2020/05/12

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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
Email 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
Email k-I-sonoko@nms.ac.jp

Sponsor
Institute Nippon Medical School Hospital
Institute
Department

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
Email 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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
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
2020 Year 05 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009900

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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