UMIN-CTR Clinical Trial

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

(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

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

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.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Kawasaki Medical School

Institute

Department

Personal name

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

08

Month

28

Day

URL releasing protocol

Publication of results

Published

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

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 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.

Registered date

2018

Year

08

Month

28

Day

Last modified on

2019

Year

03

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038687