Herbal Preparation Used as Adjuvant Therapy on Diabetic Ulcers

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Diabetic Foot Ulcer, Amputation

Intervention / Treatment
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* Drug: TCM
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Traditional Chinese Medicine<br>12 herbals formulation was given as an adjuvant therapy for the patients orally twice a day. | Drug: TCM<br>* The Decoction is taken orally, twice a day, treatment period is 24 weeks The herbal formulation or a placebo was given as an adjuvant therapy for the treatment of the unhealing ulcers in these diabetic patients. The formula consisted of 12 herbs, viz: Radix astragali, Rhizoma atractylodis marcocephalae, Radix stephaniae tetrandrae, Radix polygoni multiflori, Radix rehmanniae, Radix smilax china, Fructus corni, Rhizoma dioscoreae, Cortex moutan, Rhizoma alismatis, Rhizoma smilacis glabrae, and Fructus schisandrae<br>|
| Placebo Comparator: Placebo<br>Placebo was made with starch and colouring materials. Given to patient orally twice a day | Drug: Placebo<br>* Placebo taking orally, twice a day, 24 week treatment period The herbal formulation or a placebo was given as an adjuvant therapy for the treatment of the unhealing ulcers in these diabetic patients. The placebo was made with starch and colouring materials.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Limb Salvage | The number of successful limb rescued (without amputation). | 24 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic Foot Ulcer, Traditional Chinese Medicine