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An Evidence Base Study on the Clinical Effects of Integrated Western Medicine and Traditional Chinese Medicine for Diabetic Foot Ulcer Treatment


Phase 2
N/A
N/A
Not Enrolling
Both
Diabetic Foot Ulcer, Amputation

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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

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