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1.Screening
1.2.Inclusion Criteria

Eligible participant has to fullfill all of the following items

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1.3.Exclusion Criteria

Date

yyyy-mm-dd

2.Baseline
2.2.General information

Gender

Male

Your age

46 岁(years)

Date of birth:

1973-10-22 yyyy-mm-dd

Nationality

Han

Marriage history

Pulse rate

次/分

Breath frequency

次/分

Systolic pressure (SP)

mmHg

Diastolic pressure

mmHg

Did you experienced any drug allergy?

No

Namy of the drug to be allergied

Date of drug allergy happened

yyyy-mm-dd/mm-dd

Doctor signature

Date

yyyy-mm-dd

2.3.Physical examination

间断多饮多尿、体重下降24年,右足破溃1月,加重1天。患者于24年前无明显诱因出现多饮、多尿、体重下降,诊断为2型糖尿病,口服二甲双胍片0.5日二次,格列苯脲2.5毫克日二次,2年前口服药失效,血糖升高,就诊平泉县医院更改为精蛋白重组人胰岛素14单位早晚餐前15分钟皮下注射,口服二甲双胍0.5日三次,阿卡波糖100mg日三次,血糖控制可,1月前右足第三趾破溃,出现混合坏疽,蔓延足心。

Wagner grade

Signature of the doctor

Date of examination

2019-12-21 yyyy-mm-dd

2.4.Blood Routine Tests

WBC

14.2 ×109 /L

NEUT%

79 %

LY%

12.8 %

MONO%

5.9

RBC

3.33 ×10^12 /L

HGB

101 g/L

PLT

413 ×10^9 /L

Date

2019-12-21 yyyy-mm-dd

2.5.Urine and Stool Routine Tests

Acidity and allkalinity

Acidity

pH value

5.5

Urine protein

Negative

Urine red cell

Negative

Urine WBC

Negative

Urine glucos

Positive+++

Urine Bilirubin

Negative

Urine HCG

Negative

KET

Negative

SG

1.01

UBG

Negative

NIT

Negative

Date of test

2019-12-21 yyyy-mm-dd

2.6.Glucose test

Fasting blood glucos concentration

19.2 mmol/L

Two hours after breakfast

mmol/L

Two hours after lunch

mmol/L

Two hours after dinner

mmol/L

Date of test

yyyy-mm-dd

CRP

mg/L

Date of test

2019-12-21 yyyy-mm-dd

Fib

g/L

t-PA

ug/L

PAI-1

ug/L

Date of test

HbA1c

%

Date of test

yyyy-mm-dd

2.8.Serum Liver Function Tests

ALT

11 IU/L

AST

11 IU/L

γ-Glutamyltransferase

84 IU/L

Serum bilirubin

3.3 μmol/L

Indirect bilirubin

1.7 umol/L

Direct bilirubin

1.6 umol/L

Serum albumin

23 g/L

Serum total protein

61 g/L

Date of test

2019-12-21 yyyy-mm-dd

2.10.Renel Function Test

Blood uric acid

222 μmol/L

SCr

72 μmol/L

Blood urea

6.5 mmol/L

Date of test

2019-12-21 yyyy-mm-dd

2.11.Heat Function Examination

Ultrasonic echocardiography, UCG

Description in detail for abnormal

Date of examination

yyyy-mm-dd

AST

U

LDH

IU

Lactic dehydrogenase isoenzyme

α-HBDH

U/L

Creatine Kinase, CK

U/L

Creatine kinase isoenzyme, CKMB

U/L

Date of tests

yyyy-mm-dd

3.In the process of the treatment
3.1.

Signature of the doctor

Date of examination

yyyy-mm-dd

3.3.1.1、

3.2.

Signature of the doctor

yyyy-mm-dd

3.3.2.1、

3.3.2.2、

3.3.2.3、

ALT

IU/L

AST

IU/L

AST/ALT

γ-Glutamyltransferase

IU/L

GGT

U/L

Serum bilirubin

μmol/L

Indirect bilirubin

umol/L

Direct bilirubin

umol/L

Serum albumin

g/L

Serum globulin

g/L

Serum total protein

g/L

A/G

Date of test

yyyy-mm-dd

3.3.2.4、

BUN

8mmol/L

SCr

μmol/L

Blood urea

mmol/L

Blood uric acid

μmol/L

Cr

Blood endogenous creatinine clearance

ml·s-1/m*2

BUN/Cr

Date of test

yyyy-mm-dd

3.3.

Signature of the doctor

yyyy-mm-dd

3.3.3.1、

3.4.

3.3.4.1、

3.3.4.2、

3.3.4.3、

ALT

IU/L

AST

IU/L

AST/ALT

γ-Glutamyltransferase

IU/L

Serum bilirubin

μmol/L

Indirect bilirubin

umol/L

Direct bilirubin

umol/L

Serum albumin

g/L

Serum globulin

g/L

Serum total protein

g/L

A/G

Date of test

yyyy-mm-dd

3.3.4.4、

BUN

8mmol/L

SCr

μmol/L

Blood urea

mmol/L

Blood uric acid

μmol/L

Cr

Date of test

yyyy-mm-dd

3.5.

3.3.5.1、

3.6.

Signature of the doctor

Date of examination

yyyy-mm-dd

3.3.6.1、

4.At the end of the treatment
4.1.Management for Progress

Is there any additional combination drug?

4.3.Blood Routine Tests

WBC

×109 /L

NEUT%

%

LY%

%

MONO%

RBC

×10^12 /L

HGB

g/L

PLT

×10^9 /L

Researcher signature

Date

yyyy-mm-dd

4.4.Glucose test

HbA1c

%

Date of test

yyyy-mm-dd

Blood glucose

mmol/L

LAGE

MAGE

SDBG

MODD

LBGI

Date of test

yyyy-mm-dd

Daily usage of insulin

IU

Date of detection

yyyy-mm-dd

4.6.Liver Function Tests

ALT

IU/L

AST

IU/L

AST/ALT

γ-Glutamyltransferase

IU/L

Serum bilirubin

μmol/L

Indirect bilirubin

umol/L

Direct bilirubin

umol/L

Serum albumin

g/L

Serum globulin

g/L

Serum total protein

g/L

A/G

Date of test

yyyy-mm-dd

4.8.Renel Function Test

BUN

8mmol/L

SCr

μmol/L

Blood urea

mmol/L

Blood uric acid

μmol/L

Cr

Date of test

yyyy-mm-dd

4.9.Heat Function Examination

Ultrasonic echocardiography, UCG

Description in detail for abnormal

Date of examination

yyyy-mm-dd

AST

U

LDH

IU

Lactic dehydrogenase isoenzyme

α-HBDH

U/L

Creatine Kinase, CK

U/L

Creatine kinase isoenzyme, CKMB

U/L

Date of tests

yyyy-mm-dd

4.10.Image Examinations

4.16.Health Relative Quality of Life

Before primary wounding

Now (Current at moment)

5.Follow-up 1

Signature of the doctor

Date of examination

yyyy-mm-dd

1.

6.Follow-up 2

Date of examination

(yyyy-mm-dd)

1.

7.Follow-up 3

Signature of the doctor

Date of examination

yyyy-mm-dd

1.

2.

年月日(yyyy-mm-dd)

年月日(yyyy-mm-dd)

The date of the last site visiting

年月日(yyyy-mm-dd)

8.Management system of participants

Whether got the informed consent?

Date of sign the informed consent

xx年xx月xx日

9.Speciman management system
10.Data management system
11.ADR/ADE management system

Adverse events

Name of the adverse event

Date of starting

yyyy-mm-dd

Ending time

yyyy-mm-dd

Does it continues to now

Severity

Corelation with the study drug

The method of treating the drug

The outcome

Is it sevious adverse event?

Did it resulted in stoped the study?

Possible reason of causing the adverse event

Person who report the adverse event

Time of the reporting

yyyy-mm-dd-hh-min.

12.Madicine management system
13.Instruments management system
14.SOPs
14.1.Treatment SOP
14.2.Nursing SOP
14.3.Specimen collection SOP
15.Research team
15.1.Institutions
15.2.Researchers
16.Design, Methods
16.1.Calculation of sample size