Trial Information
An Evidence Base Study on the Clinical Effects of Integrated Western Medicine and Traditional Chinese Medicine for Diabetic Foot Ulcer Treatment
Inclusion Criteria:
- Well Controlled diabetic state
- Presence of gangrene or non-healing ulcer in diabetic patients over the foot or feet.
Infection should be well controlled.
- Good glycaemic control
Exclusion Criteria:
- Pregnant women and women at risk of conception
- Patients taking digitalis glycosides
- Patients with abnormal liver function tests
- Patients with plasma creatinine great then 150 umol/l or unstable renal function
- Poorly controlled Diabetes Mellitus
- Uncontrolled infection
- History of adverse reaction to herbal medicine
- Unstable medical conditions
- Non-compliance with regime
Type of Study:
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
Outcome Measure:
Number of Participants With Limb Salvage
Outcome Description:
The number of successful limb rescued (without amputation).
Outcome Time Frame:
24 weeks
Safety Issue:
No
Principal Investigator
Leung Ping Chung, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Dept. of Orthopaedics & Traumatology, CUHK
Authority:
Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
Study ID:
CRE-8342
NCT ID:
NCT00393510
Start Date:
November 2000
Completion Date:
March 2006
Related Keywords:
- Diabetic Foot Ulcer
- Amputation
- Diabetic Foot Ulcer
- Traditional Chinese Medicine
- Ulcer
- Foot Ulcer
- Diabetic Foot