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Completed

NCT Number: NCT00393510

Herbal Preparation Used as Adjuvant Therapy on Diabetic Ulcers

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.

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Key information

Conditions

Diabetic Foot Ulcer Amputation Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TCM

Drug

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

Placebo

Drug

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.

Primary outcomes

  1. Number of Participants With Limb Salvage

    Time frame: 24 weeks

    The number of successful limb rescued (without amputation).

Secondary outcomes

  1. Tumour Necrosis Factor-alpha Levels in Serum

    Time frame: Baseline and 4 week

    The state of inflammation at baseline and at 4 weeks after treatment. TNF-alpha are in value of serum level.

  2. Time of Ulcer Healing

    Time frame: 24 week

    Time taken for maturation of granulation to enable skin grafting.

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

An Evidence Base Study on the Clinical Effects of Integrated Western Medicine and Traditional Chinese Medicine for Diabetic Foot Ulcer Treatment

Important dates

Study start
2000
Primary completion
2006
Study completion
2006
First posted
Oct 27, 2006
Registry last updated
Jul 13, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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