UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013641 |
|---|---|
| Receipt number | 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 20:14:45 |
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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
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
tniikura@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015921
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