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

NCT01389362 | Completed Phase 2 DMC

• 1 other identifier: CRE-2008.581
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot Ulcer

Keywords

Diabetes; foot ulcer; Chinese herbal medicine

Outcome Measures

Primary Outcomes (1)

• Resolution/progression of foot ulcer based on PEDIS

  6 months

Secondary Outcomes (1)

• Hospital admission/attendance/stay

  6 months

Study Arms (2)

Chinese Herbal Medicine

ACTIVE COMPARATOR

2 sachets of Chinese Herbal Medicine to be taken daily

Drug: Chinese herbal medicine (Radix Rehmanniae and Radix Astragali)

Placebo arm

PLACEBO COMPARATOR

2 sachets to be taken daily

Drug: Placebo comparator

Interventions

Chinese herbal medicine (Radix Rehmanniae and Radix Astragali) DRUG

2 sachets to be taken daily

Chinese Herbal Medicine

Placebo comparator DRUG

2 sachets to be taken daily

Placebo arm

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Diabetes and Endocrine Centre

Hong Kong SAR, Hong Kong SAR, China

Location

Related Publications (1)

• Ko CH, Yi S, Ozaki R, Cochrane H, Chung H, Lau W, Koon CM, Hoi SW, Lo W, Cheng KF, Lau CB, Chan WY, Leung PC, Chan JC. Healing effect of a two-herb recipe (NF3) on foot ulcers in Chinese patients with diabetes: a randomized double-blind placebo-controlled study. J Diabetes. 2014 Jul;6(4):323-34. doi: 10.1111/1753-0407.12117. Epub 2014 Feb 24.

  PMID: 24330156 DERIVED

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus; Foot Ulcer

Interventions

rehmannia root; Huang Qi

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Endocrine System Diseases; Diabetic Neuropathies; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Foot Diseases

Study Officials

• Juliana NA Chan, MBChB, FRCP

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 6, 2011
• First Posted: July 8, 2011
• Study Start: May 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: July 28, 2011

Record last verified: 2011-07

Locations

CN (1)