Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00186

2 Trial Registration Date

2009-03-09

i Registration Status

Prospective

3 Secondary IDs

N/A

4 Source(s) of Funding

Institute of Chinese Medicine

5 Primary Sponsor

Institute of Chinese Medicine

6 Secondary Sponsor

N/A

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Ms Carmen Fong

ii Address

iii Phone

2252-8872

iv Email

Phone

v Affiliation

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Dr Risa Ozaki

ii Address

iii Phone

2632-3215

iv Email

Phone

v Affiliation

vi Country

9 Official Scientific Title of the Study

The Healing Effect of a Two-Herb Recipe on Foot Ulcer in Chinese Patients with Type 2 Diabetes: A Randomized, Placebo-Controlled Study

10 Public Title

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

N/A

12 Countries of Recruitment

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2009-02-19

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Diabetic foot ulcer

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Chinese herbal medicine containing 2 herbs (Radix Rehmanniae and Radix Astragali)

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

6 months

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Placebo

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Inclusion Criteria
•Type 2 diabetic subjects with documented evidence of mild diabetic foot ulcer
•Male or female patients attending Podiatry Clinics at the hospitals of the New Territories East Cluster
•Aged between 20 and 75 years old inclusive
•All patients should be on stable dose of medication 4 weeks prior to enrolment
•Capable of giving written informed consent
•If the patient is a woman of child-bearing potential, she must agree to use adequate method of contraception throughout the study period, unless surgically sterilized.
oNote: Acceptable methods of birth control are: hormonal contraceptive, intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, or vasectomy.

Exclusion Criteria
•Patients with end-stage renal disease as defined by the need for dialysis or on renal replacement program.
•Patients with advanced diabetic eye disease as defined by the history of laser therapy, retinal detachment or vitreous hemorrhage.
•Pregnancy, breast feeding, or patient has plans of becoming pregnant during the study period.
•Known allergy to TCM
•Contraindication or intolerance to use of aspirin, statin, ACEI or ARB.
•History of major gastrointestinal bleeding in the 5 years prior to consent.
•Congestive heart failure of any severity.
•Significant cardiovascular disease within 3 months of enrolment including acute coronary syndrome, cardiac revascularization procedure, transient ischemic attack and cerebrovascular accident.
•HbA1c ≥ 10%
•Severe liver function impairment (≥3× ULN of ALT) and renal impairment (eGFR < 30 ml/min/1.73 m2).
•Investigational drugs within 30 days of enrolment.
•Patient taking TCM in the 8 weeks prior to enrolment into the study.
•Any other medical condition considered unsuitable for enrolment by investigator

ii Exclusion Criteria

iii Age Minimum

iv Age Maximum

v Gender

18 Study Type

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Placebo

iii Degree of masking

Double-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2009-04-01

21 Target Sample Size

74 patient

22 Recruitment Status

Unknown

23 Primary Outcome

-Time to resolution of foot ulcer based on PEDIS
-Time to failure of intensive ambulatory treatment by medical team and podiatrist, requiring referral to orthopaedic/surgical teams

24 Secondary Outcome

-Number of hospital admissions
-Total hospitalization days
-Changes in metabolic and inflammatory parameters including:
- HbA1c
- Fasting plasma glucose
- Fasting lipid profiles
- Urine albumin/creatinine ratio
-Inflammatory markers– high sensitive C-reactive protein, white blood cell count, TNF-α

- Genomic profile: Blood samples (pre- and post-treatment) for quantitation of RNA of inflammatory cytokines and growth factors

- Quality of life: SF-36

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2011-05-13

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

No

ii Link to Recruitment Information

N/A

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Trial History Detail on 2009-03-09