Phase 2 Completed N=80 Randomized Quadruple-blind Treatment

Herbal Preparation Used as Adjuvant Therapy on Diabetic Ulcers

Diabetic Foot Ulcers · Amputation

Source: ClinicalTrials.gov NCT00393510 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2010

Primary outcomePrimary: Number of Participants With Limb Salvage — 37; 31 Participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Limb Salvage	37; 31	—
SECONDARY Tumour Necrosis Factor-alpha Levels in Serum	48; 44; 28; 39	—
SECONDARY Time of Ulcer Healing	5.9; 9.2	—

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

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Data sourced from ClinicalTrials.gov (NCT00393510). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.