UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029516 |
|---|---|
| Receipt number | R000033714 |
| Scientific Title | The effect of electrical stimulation on pressure injuries: double-blind controlled cross over study.(Verification by double blind crossover comparison test.) |
| Date of disclosure of the study information | 2017/10/13 |
| Last modified on | 2019/03/31 22:04:28 |
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Basic information
Public title
The effect of electrical stimulation on pressure injuries: double-blind controlled cross over study.(Verification by double blind crossover comparison test.)
Acronym
The effect of electrical stimulation on pressure injuries: double-blind controlled cross over study.(Verification by double blind crossover comparison test.)
Scientific Title
The effect of electrical stimulation on pressure injuries: double-blind controlled cross over study.(Verification by double blind crossover comparison test.)
Scientific Title:Acronym
The effect of electrical stimulation on pressure injuries: double-blind controlled cross over study.(Verification by double blind crossover comparison test.)
Region
| Japan |
Condition
Condition
Pressure injury
Classification by specialty
| Dermatology | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the therapeutic effects of monophasic pulsed micro-current stimulation which promotes migration and proliferation of human dermal fibroblasts on pressure injury with double-blind controlled cross over study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Wound contraction
Compare the rate of wound contraction between sham period and electrical stimulation period.
Compare the wound contraction ratio in the current stimulation period of two weeks and the wound contraction ratio in the two weeks sham stimulation period.
Key secondary outcomes
DESIGN-R
Observation of wound
Clinical blood test
Adverse events (anthema, redness, dysesthesia as itch sensation, pain, heat sensation, and abnormal sensation as oppressing feeling)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
The subjects are divided into sham group or stimulation group after observation for one week. Sham stimulation (0 mA) is took on the wound in the sham group, and monophasic pulsed micro-current (0.17 mA, 2 Hz) is conducted on the wound in the stimulation group for 2 weeks.
After that, wash-out period is served for one week after 2 weeks of electrical stimulation period.
Subsequently, each group are crossed and conducted sham (0 mA) or electrical stimulation (0.17 mA, 2 Hz) for 2 weeks.
After the electrical stimulation period, observation period is set for one week.
Interventions/Control_2
The subjects are divided into sham group or stimulation group after observation for one week. Sham stimulation (0 mA) is took on the wound in the sham group, and monophasic pulsed micro-current (0.17 mA, 2 Hz) is conducted on the wound in the stimulation group for 2 weeks.
After that, wash-out period is served for one week after 2 weeks of electrical stimulation period.
Subsequently, each group are crossed and conducted sham (0 mA) or electrical stimulation (0.17 mA, 2 Hz) for 2 weeks.
After the electrical stimulation period, observation period is set for one week.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) The patients with the pressure injury of National Pressure Ulcer Advisory Panel pressure injuries stage 2, 3 or 4
2) The patients who are expected to hospitalize for more than one month.
3) The patients who have pressure injury for more than one month.
4) The patients who consent in writing in person or representative.
Key exclusion criteria
1) The patients with a malignant tumor.
2) Severe infection in pressure injury.
3) Patients with arterial/ venous thrombosis or thrombophlebitis.
4) Patients with unstable general condition such as high fever above 38.0 degrees.
5) Patients who cannot keep the electrodes on the wound.
6) Patients who develop a feeling of anxiety about the electrical stimulation.
7) Patients who the primary doctor or dermatologist judge the subjects.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Terutaka |
| Middle name | |
| Last name | Hiramatsu |
Organization
Housenka Hospital
Division name
Department of Rehabilitation
Zip code
567-0067
Address
2-9-36, Nishi-Fukui, Ibaraki-shi, Osaka
TEL
072-641-7063
rihaptot@seiwa-h.org
Public contact
Name of contact person
| 1st name | Terutaka |
| Middle name | |
| Last name | Hiramatsu |
Organization
Housenka Hospital
Division name
Department of Rehabilitation
Zip code
567-0067
Address
2-9-36, Nishi-Fukui, Ibaraki-shi, Osaka
TEL
072-641-7063
Homepage URL
rihaptot@seiwa-h.org
Sponsor or person
Institute
Housenka Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Kobe Gakuin University
Name of secondary funder(s)
Kobe Gakuin University
IRB Contact (For public release)
Organization
Housenka Hospital
Address
2-9-36, Nishi-Fukui, Ibaraki-shi, Osaka
Tel
072-641-7063
rihaptot@seiwa-h.org
Secondary IDs
Secondary IDs
YES
Study ID_1
HK 17-01
Org. issuing International ID_1
Housenka Hospital
Study ID_2
HEB17-54
Org. issuing International ID_2
Kobe Gakuin University
IND to MHLW
Institutions
Institutions
医療法人 成和会 ほうせんか病院（大阪府）
Housenka Hospital(Osaka)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 13 | 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
17
Results
Statistical analysis of the current stimulation group (0.17 mA, 2 Hz) and the sham stimulation group (0 mA) showed that the wound area, pocket area were in the current stimulation group (0.17 mA, 2 Hz) , Significant differences were observed (P <0.05).
Results date posted
| 2019 | Year | 03 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The patients who have pressure injury admitted to Housenka hospital.
Participant flow
The subjects are divided into sham group or stimulation group after observation for one week. Sham stimulation (0 mA) is took on the wound in the sham group, and monophasic pulsed micro-current (0.17 mA, 2 Hz) is conducted on the wound in the stimulation group for 2 weeks.
After that, wash-out period is served for one week after 2 weeks of electrical stimulation period.
Subsequently, each group are crossed and conducted sham (0 mA) or electrical stimulation (0.17 mA, 2 Hz) for 2 weeks.
After the electrical stimulation period, observation period is set for one week.
Adverse events
During the study period, dermatologists confirmed that there were no adverse events.
Outcome measures
The wound area, pocket area and pressure injury evaluation(DESIGN-R) were measured twice a week. The affected part was photographed.
Plan to share IPD
IPD sharing Plan description
The samples and information obtained in the study were identified using the subject identification code without using the subject's name and initials (no correspondence table was created).
In addition, also in the exchange of data with the joint research institute (Kobe Gakuin University), anonymous processing information (non-identifying processing information) was used so that the subject was not identified.
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 09 | Month | 05 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 07 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 07 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 12 | Day |
Last modified on
| 2019 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033714
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