The Healing Effect of a Two-Herb Recipe on Foot Ulcer in Chinese Patients With Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01389362
Recruitment Status : Completed
First Posted : July 8, 2011
Last Update Posted : July 28, 2011
Information provided by:
Chinese University of Hong Kong

Brief Summary:
There is now a global epidemic of diabetes and obesity affecting more than 300 million people worldwide with Asia in the forefront. In Hong Kong, diabetes affects more than 10% of the population. Patients with diabetes have a 12—25% lifetime risk of developing a foot ulcer.The abnormal metabolic milieus of hyperglycemia, hyperlipidemia, hypertension, pro-thrombotic state and chronic inflammation in diabetes causes atherosclerosis.A significant proportion of subjects have underlying peripheral arterial disease and neuropathy. These subjects are at great risk of developing infective foot ulceration secondary to impaired vascular supply, sensory loss and minor trauma.Without prompt and proper medical treatment, these infective ulcers will deteriorate leading to gangrene and limb amputation. In-vitro and in-vivo studies revealed that 5 out of the 12 herbs were effective in promoting fibroblast proliferation and angiogenesis. To minimize potential drug interactions and adverse effects from multiple components in a recipe of Traditional Chinese Medicine (TCM), the investigators have developed a simplified formula from the 12 herbs consisting of only two herbs. In this proof-of-concept study, the investigators hypothesize that the novel recipe of herbal medicine will expedite healing of early foot ulcer by promoting vascularisation and granulation as well as modulating inflammatory response.

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Drug: Chinese herbal medicine (Radix Rehmanniae and Radix Astragali) Drug: Placebo comparator Phase 2 Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Healing Effect of a Two-Herb Recipe on Foot Ulcer in Chinese Patients With Type 2 Diabetes: A Randomized, Placebo-Controlled Study
Study Start Date : May 2009
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Chinese Herbal Medicine
2 sachets of Chinese Herbal Medicine to be taken daily
Drug: Chinese herbal medicine (Radix Rehmanniae and Radix Astragali)
2 sachets to be taken daily
Placebo Comparator: Placebo arm
2 sachets to be taken daily
Drug: Placebo comparator
2 sachets to be taken daily

Primary Outcome Measures :
  1. Resolution/progression of foot ulcer based on PEDIS [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Hospital admission/attendance/stay [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Type 2 diabetic subjects with documented evidence of mild diabetic foot ulcer

  • Male or female patients attending Diabetic Clinics and/or 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
  • 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.

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 drugs
  • 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 any Chinese herbal medicine in the 8 weeks prior to enrolment into the study
  • Any other medical conditions that is considered as unsuitable for the study by investigator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01389362

China, Hong Kong SAR
Diabetes and Endocrine Centre
Hong Kong SAR, Hong Kong SAR, China
Sponsors and Collaborators
Chinese University of Hong Kong
Principal Investigator: Juliana NA Chan, MBChB, FRCP Chinese University of Hong Kong

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Prof. Chan Chung Ngor, Juliana, Chinese University of Hong Kong Identifier: NCT01389362     History of Changes
Other Study ID Numbers: CRE-2008.581
First Posted: July 8, 2011    Key Record Dates
Last Update Posted: July 28, 2011
Last Verified: July 2011

Keywords provided by Chinese University of Hong Kong:
foot ulcer
Chinese herbal medicine

Additional relevant MeSH terms:
Diabetic Foot
Foot Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases