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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000044372
Receipt No. R000050684
Scientific Title Relationship between fluctuations in skin perfusion pressure value and wound healing in patients with critical limb ischemia undergoing hemodialysis
Date of disclosure of the study information 2021/06/01
Last modified on 2021/05/30

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Basic information
Public title Relationship between fluctuations in skin perfusion pressure value and wound healing in patients with critical limb ischemia undergoing hemodialysis
Acronym Relationship between fluctuations in skin perfusion pressure value and wound healing
Scientific Title Relationship between fluctuations in skin perfusion pressure value and wound healing in patients with critical limb ischemia undergoing hemodialysis
Scientific Title:Acronym Relationship between fluctuations in skin perfusion pressure value and wound healing
Region
Japan

Condition
Condition critical limb ischemia
Classification by specialty
Cardiology Nephrology Vascular surgery
Plastic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We investigated skin perfusion pressure values that more accurately reflected wound healing in severely ischemic limbs before and after dialysis.
Basic objectives2 Others
Basic objectives -Others Obtain accuracy, positive predictive value, negative predictive value, sensitivity, and specificity of SPP test and wound healing before and after dialysis.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Wound healing rate within 12 weeks after SPP test
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Hemodialysis patients treated for leg ulcers due to critical limb ischemia in our department between 2016 and 2021were included
Key exclusion criteria Cases in which the course of wound healing could not be observed for 12 weeks or more, cases in which SPP examination could not be performed
Target sample size 30

Research contact person
Name of lead principal investigator
1st name yutaro
Middle name
Last name yamashita
Organization Tokushima university
Division name plastic surgery
Zip code 770-8503
Address 3-18-15 Kuramotocho, Tokushima City, Tokushima Prefecture
TEL 088-633-7296
Email thestarstripjp@yahoo.co.jp

Public contact
Name of contact person
1st name yutaro
Middle name
Last name yamashita
Organization Tokushima University
Division name plastic surgery
Zip code 770-8503
Address 3-18-15 Kuramotocho, Tokushima City, Tokushima Prefecture
TEL 088-633-7296
Homepage URL
Email thestarstripjp@yahoo.co.jp

Sponsor
Institute Department of plastic surgery in Tokushima University
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor none
Name of secondary funder(s) none

IRB Contact (For public release)
Organization Tokushima University
Address 3-18-15 Kuramotocho, Tokushima City, Tokushima Prefecture
Tel 088-633-7296
Email thestarstripjp@yahoo.co.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

Other administrative information
Date of disclosure of the study information
2021 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled 30
Results Significant differences in the positive predictive value (HD day: 100%, non-HD day: 40%; P=0.003), specificity (HD day: 100%, non-HD day: 68.1%; P=0.023), and accuracy (HD day: 90.9%, non-HD day: 63.6%; P=0.015) were observed between the HD day and non-HD day groups.
Results date posted
2021 Year 05 Month 30 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2021 Year 05 Month 30 Day
Baseline Characteristics This retrospective study included 30 patients on hemodialysis who were treated for ischemic ulcers at our department between January 2016 and March 2021. Among these patients, those in whom the course of ulcer was for 12 or more week were included in this study. A total of 88 SPP tests were performed on the lower limbs of these 30 patients during the observation period
Participant flow
Adverse events none
Outcome measures Ulcer healing rate within 12 weeks
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2021 Year 02 Month 09 Day
Date of IRB
2021 Year 03 Month 29 Day
Anticipated trial start date
2021 Year 03 Month 29 Day
Last follow-up date
2021 Year 05 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2021 Year 05 Month 30 Day
Last modified on
2021 Year 05 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050684

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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