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

This study has been completed.
Sponsor:
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01389362
First received: July 6, 2011
Last updated: July 27, 2011
Last verified: July 2011
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • Resolution/progression of foot ulcer based on PEDIS [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Hospital admission/attendance/stay [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 16
Study Start Date: May 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01389362

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

No publications provided by Chinese University of Hong Kong

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Chan Chung Ngor, Juliana, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01389362     History of Changes
Other Study ID Numbers: CRE-2008.581
Study First Received: July 6, 2011
Last Updated: July 27, 2011
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

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

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetic Foot
Foot Ulcer
Ulcer
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Diabetic Angiopathies
Diabetic Neuropathies
Endocrine System Diseases
Foot Diseases
Glucose Metabolism Disorders
Leg Ulcer
Metabolic Diseases
Pathologic Processes
Skin Diseases
Skin Ulcer
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014