The Healing Effect of a Two-Herb Recipe on Foot Ulcer in Chinese Patients With Type 2 Diabetes
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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 |
- Resolution/progression of foot ulcer based on PEDIS [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- 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 |
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| China, Hong Kong SAR | |
| Diabetes and Endocrine Centre | |
| Hong Kong SAR, Hong Kong SAR, China | |
| Principal Investigator: | Juliana NA Chan, MBChB, FRCP | Chinese University of Hong Kong |
More Information
No publications provided
| 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 Ulcer Foot Ulcer Diabetic Foot Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Pathologic Processes |
Foot Diseases Skin Diseases Leg Ulcer Skin Ulcer Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases Diabetes Complications Diabetic Neuropathies |
ClinicalTrials.gov processed this record on June 18, 2013