Clinical trial NCT00393510: Herbal Preparation Used as Adjuvant Therapy on Diabetic Ulcers
Official title: An Evidence Base Study on the Clinical Effects of Integrated Western Medicine and Traditional Chinese Medicine for Diabetic Foot Ulcer Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Foot Ulcer
Amputation
Keywords: Diabetic Foot Ulcer
Traditional Chinese Medicine
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2006-10-27
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic foot ulcers occurring among diabetic patients are difficult to heal. The frequent elderly age with co-morbidities, vascular insufficiencies, peripheral neuropathies and super imposed infections, all contribute towards the chronicity and failure of treatment. Preserving the ulcerated limb is the patients' wish. On the other hand, an infected ulcer that never heals just unnecessarily prolongs suffering. Nevertheless, patients earnestly like to try all methods of healing before accepting amputation.

Objective:To determine whether a course of herbal preparation used as an adjuvant therapy for diabetic patients suffering from chronic foot ulcers may promote healing so that major leg amputation can be avoided.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Limb Salvage
timeFrame: 24 weeks
Secondary outcomes:
measure: Tumour Necrosis Factor-alpha Levels in Serum
timeFrame: Baseline and 4 week
measure: Time of Ulcer Healing
timeFrame: 24 week
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Department of Orthopaedics & Traumatology, Prince of Wales hospital
city: Hong Kong
country: China
facility: Department of Orthopaedics and Traumatology, Kwong Wah Hospital
Study officials:
affiliation: Dept. of Orthopaedics & Traumatology, CUHK
name: Leung Ping Chung, MD
role: PRINCIPAL_INVESTIGATOR
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