Trial History Detail on 2009-12-30





Institute of Chinese Medicine

Institute of Chinese Medicine


Ms Carmen Fong

5/F, School of Public Health Building, Institute of Chinese Medicine, Prince of Wales Hospital, Shatin, NT

Phone 2252-8872

Institute of Chinese Medicine

Dr Risa Ozaki

Diabetes and Endocrine Center, Flat 8A, Block B Staff Quarters, Prince of Wales Hospital, Shatin, NT

Phone 2632-3215

Chinese University of Hong Kong

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

The Healing Effect of a Two-Herb Recipe on Foot Ulcer in Chinese patients with type 2 diabetes: A randomized, placebo-controlled study


Hong Kong



Diabetic foot ulcer


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

6 months


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
•Age of 20 years or above
•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

20 years

No maximum age limit

Both Male and Female







74 patient


-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

-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




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