Herbal Preparation Used as Adjuvant Therapy on Diabetic Ulcers

Chinese University of Hong Kong80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Diabetic Foot Ulcer Amputation

Interventions

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

PlaceboDRUG

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (2)

Department of Orthopaedics & Traumatology, Prince of Wales hospital

Hong Kong, China

Department of Orthopaedics and Traumatology, Kwong Wah Hospital

Hong Kong, China

Outcomes

Primary Outcomes

Number of Participants With Limb Salvage

The number of successful limb rescued (without amputation).

Time frame: 24 weeks

Secondary Outcomes

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.

Time frame: Baseline and 4 week

Time of Ulcer Healing

Time taken for maturation of granulation to enable skin grafting.

Time frame: 24 week