Herbal Preparation Used as Adjuvant Therapy on Diabetic Ulcers
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
80 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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