Herbal Preparation Used as Adjuvant Therapy on Diabetic Ulcers

Phase 2

Completed

• Conditions: Diabetic Foot Ulcer; Amputation
• Interventions: Drug: TCM; Drug: Placebo

• Registration Number: NCT00393510
• Lead Sponsor: Chinese University of Hong Kong

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-11
• Primary Completion: 2006-03
• Study Completion: 2006-03
• Study First Submitted: 2006-10-26
• Study First Submitted QC: 2006-10-26
• Study First Posted: 2006-10-27
• Results First Submitted: 2009-11-23
• Results First Submitted QC: 2010-06-02
• Status Verified: 2010-07
• Results First Posted: 2010-07-01
• Last Update Submitted: 2010-07-06
• Last Update Posted: 2010-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional Chinese Medicine	TCM	12 herbals formulation was given as an adjuvant therapy for the patients orally twice a day.
Placebo	Placebo	Placebo was made with starch and colouring materials. Given to patient orally twice a day

Primary Outcome Measures

Name	Time	Method
Number of Participants With Limb Salvage	24 weeks	The number of successful limb rescued (without amputation).

Secondary Outcome Measures

Name	Time	Method
Tumour Necrosis Factor-alpha Levels in Serum	Baseline and 4 week	The state of inflammation at baseline and at 4 weeks after treatment. TNF-alpha are in value of serum level.
Time of Ulcer Healing	24 week	Time taken for maturation of granulation to enable skin grafting.

Trial Locations

Locations (2)

Department of Orthopaedics and Traumatology, Kwong Wah Hospital; 🇨🇳 Hong Kong, China

Department of Orthopaedics & Traumatology, Prince of Wales hospital; 🇨🇳 Hong Kong, China