UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000029516
Receipt No. 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 (Ver. 10)

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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
Last 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
Email rihaptot@seiwa-h.org

Public contact
1st 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
Email rihaptot@seiwa-h.org

Sponsor
Institute Housenka Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033714