UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000013641
Receipt No. R000015921
Scientific Title Exploratory clinical study on effects to the blood flow and safety of transcutaneous application of carbon dioxide for fractured limbs
Date of disclosure of the study information 2014/07/01
Last modified on 2019/12/10 (Ver. 13)

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Basic information
Public title Exploratory clinical study on effects to the blood flow and safety of transcutaneous application of carbon dioxide for fractured limbs
Acronym Investigation of effects of transcutaneous application of carbon dioxide to fractured limbs
Scientific Title Exploratory clinical study on effects to the blood flow and safety of transcutaneous application of carbon dioxide for fractured limbs
Scientific Title:Acronym Investigation of effects of transcutaneous application of carbon dioxide to fractured limbs
Region
Japan

Condition
Condition fracture
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess accelerating effects to the blood flow and safety of transcutaneous application of carbon dioxide for fractured limbs
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Validation of accelerating effects to the blood flow of transcutaneous application of carbon dioxide for fractured limbs
Key secondary outcomes Validation of safety of transcutaneous application of carbon dioxide for fractured limbs

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Device,equipment
Interventions/Control_1 Transcutaneous application of carbon dioxide to fractured limbs
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
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with fracture of lower extremities
Both acute phase and chronic phase of fracture
Nonunion and bone defect
Age over 15
Written informed consent
Closed fracture and open fracture
Conservative treatment and surgical treatment
Any methods of surgical treatment
Key exclusion criteria Pathological fracture
Peripheral artery disease or ischemia in the fractured limb
Skin disease in the fractured limb
Infection in the fractured limb
Inadequate condition both general and local
No written informed consent
Patients who are judged as contraindication with any reasons by the doctors in charge
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Takahiro
Middle name
Last name Niikura
Organization Kobe University Graduate School of Medicine
Division name Orthopaedic Surgery
Zip code 650-0017
Address 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL 078-382-5985
Email tniikura@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name Takahiro
Middle name
Last name Niikura
Organization Kobe University Graduate School of Medicine
Division name Orthopaedic Surgery
Zip code 650-0017
Address 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL 078-382-5985
Homepage URL
Email tniikura@med.kobe-u.ac.jp

Sponsor
Institute Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization Kobe University Graduate School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Clinical & Translational Research Center, Kobe University Hospital
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Japan
Tel 078-382-6669
Email chiken@med.kobe-u.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 神戸大学医学部附属病院（兵庫県）

Other administrative information
Date of disclosure of the study information
2014 Year 07 Month 01 Day

Related information
URL releasing protocol Not applicable
Publication of results Published

Result
URL related to results and publications Not applicable
Number of participants that the trial has enrolled 20
Results 
Nineteen patients were subjected to complete analysis. No adverse events were observed. Arterial and expired gas analyses revealed no adverse systemic effects including hypercapnia. The mean ratio of blood flow 20 min after CO2 therapy compared with the pre-treatment level increased by approximately 2-fold in a time-dependent manner.
Results date posted
2019 Year 12 Month 02 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2019 Year 11 Month 25 Day
Baseline Characteristics 
Twenty patients were enrolled to the trial in accordance with the study design. One of the patients dropped out. Therefore, all analyses were conducted using the data obtained from the remaining 19 patients. Of the 19 patients for whom complete data analyses were performed, 13 were men and six were women, with a mean age of 48.7 years and mean body mass index of 25.6.
Participant flow 
Patients with fractures of the femur and tibia were prospectively enrolled into this study with ethical approval and informed consent. The CO2 absorption-enhancing hydrogel was applied to the fractured lower limbs of patients, and then 100% CO2 was administered daily into a sealed space for 20 min over 4 weeks postoperatively.
Adverse events 
None
Outcome measures 
Safety was assessed based on vital signs, blood parameters, adverse events, and arterial and expired gas analyses. As the efficacy outcome, blood flow at the level of the fracture site and at a site 5 cm from the fracture in the affected limb was measured using a laser Doppler blood flow meter.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 07 Month 16 Day
Date of IRB
2014 Year 05 Month 21 Day
Anticipated trial start date
2014 Year 07 Month 03 Day
Last follow-up date
2016 Year 08 Month 26 Day
Date of closure to data entry
2016 Year 08 Month 26 Day
Date trial data considered complete
2016 Year 08 Month 26 Day
Date analysis concluded
2016 Year 09 Month 22 Day

Other
Other related information Published in the BMC Musculoskeletal Disorders on November 25, 2019.

Management information
Registered date
2014 Year 04 Month 04 Day
Last modified on
2019 Year 12 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015921