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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033925
Receipt No. R000038687
Scientific Title Compatibility of SPP in the Society for Vascular Surgery Wound, Ischemia, and foot Infection (WIfI) classification system
Date of disclosure of the study information 2018/08/28
Last modified on 2019/03/15

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Basic information
Public title Compatibility of SPP in the Society for Vascular Surgery Wound, Ischemia, and foot Infection (WIfI) classification system
Acronym Compatibility of SPP in the Society for Vascular Surgery Wound, Ischemia, and foot Infection (WIfI) classification system
Scientific Title Compatibility of SPP in the Society for Vascular Surgery Wound, Ischemia, and foot Infection (WIfI) classification system
Scientific Title:Acronym Compatibility of SPP in the Society for Vascular Surgery Wound, Ischemia, and foot Infection (WIfI) classification system
Region
Japan

Condition
Condition (1)presence of a foot ulcer
(2)ischemic pain at rest
Classification by specialty
Cardiology Endocrinology and Metabolism Nephrology
Cardiovascular surgery Plastic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In the WIfI classification, tcPO2 is used as a method of evaluating ischemia of the lower extremity. However, tcPO2 is not widely used in Japan. Skin perfusion pressure (SPP) is primarily used to evaluate lower limb ischemia, which makes it difficult to apply the WIfI classification in Japan. The purposes of this study is to evaluate the SPP for each WIfI classification stage among patients with foot wounds.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes (1)limb amputations (major or minor),one year after tracking.
Key secondary outcomes (2)wound status (healed, improved, no change, worsened), and (3) all-cause mortality.

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
13 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria (1)Ischemic pain at rest (ABI: <0.40, AP: <50, TP <30, TcPO2 <20)
(2)Presence of a diabetic foot ulcer
(3)Non-healing lower limb or foot ulceration of at least 2 weeks duration
(4)Gangrene involving any portion of the foot or lower limb
Key exclusion criteria Pure venous ulcers, acute limb ischemia,ischemia due to emboli, acute trauma or mangled extremity, and wounds related to non-atherosclerotic conditions such as vasculitis, collagen vascular disease, Buerger's disease, neoplasia, dermatosis, or radiation.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kiichi Inagawa
Organization Kawasaki Medical School
Division name Plastic and Reconstructive Surgery
Zip code
Address 577 Matsushima, Kurashiki city, Okayama, Japan
TEL 086-462-1111
Email k.inagawa@med.kawasaki-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomomi Kimura
Organization Kawasaki Medical School
Division name Plastic and Reconstructive Surgery
Zip code
Address 577 Matsushima, Kurashiki city, Okayama, Japan
TEL 086-462-1111
Homepage URL
Email tomomix0711@yahoo.co.jp

Sponsor
Institute Kawasaki Medical School
Institute
Department

Funding Source
Organization Self funding
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
Address
Tel
Email

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
2018 Year 08 Month 28 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Among the 76 patients and 91 limbs included in the study, 61 patients had wounds on only one limb, 15 had wounds on bilateral lower limbs. 
The mean age of patients was 70.5 years, 72% were men, 83% had diabetes, and 28% were on dialysis. The number of limbs in each WIfI classification comprised: Stage 1: 25 limbs, Stage 2: 23 limbs, Stage 3: 19 limbs, and Stage 4: 24 limbs. The amputation rates after 1 year were: Stage 1: 8%, Stage 2: 22%, Stage 3: 26%, and Stage 4: 42%, and the wound healing rates were: Stage 1: 72%, Stage 2: 48%, Stage 3: 37%, and Stage 4: 3%. The SPP mean value (mmHg) according to ischemia grade was I-0: 52.1, I-1: 41.1, I-2: 27.1, and I-3: 18.8.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 07 Month 27 Day
Date of IRB
2016 Year 10 Month 11 Day
Anticipated trial start date
2018 Year 08 Month 28 Day
Last follow-up date
2018 Year 12 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information After statistical analysis, the SPP boundary values (mmHg) that were useful with WIfI classifications were: I-0/I-1: 45, I-1/I-2: 35, and I-2/I-3: 25.

Management information
Registered date
2018 Year 08 Month 28 Day
Last modified on
2019 Year 03 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038687

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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