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Herbal Preparation Used as Adjuvant Therapy on Diabetic Ulcers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00393510
Recruitment Status : Completed
First Posted : October 27, 2006
Results First Posted : July 1, 2010
Last Update Posted : July 13, 2010
Information provided by:
Chinese University of Hong Kong

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Amputation Drug: TCM Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Evidence Base Study on the Clinical Effects of Integrated Western Medicine and Traditional Chinese Medicine for Diabetic Foot Ulcer Treatment
Study Start Date : November 2000
Actual Primary Completion Date : March 2006
Actual Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Traditional Chinese Medicine
12 herbals formulation was given as an adjuvant therapy for the patients orally twice a day.
Drug: TCM

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 Comparator: Placebo
Placebo was made with starch and colouring materials. Given to patient orally twice a day
Drug: Placebo

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 Outcome Measures :
  1. Number of Participants With Limb Salvage [ Time Frame: 24 weeks ]
    The number of successful limb rescued (without amputation).

Secondary Outcome Measures :
  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.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00393510

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Department of Orthopaedics & Traumatology, Prince of Wales hospital
Hong Kong, China
Department of Orthopaedics and Traumatology, Kwong Wah Hospital
Hong Kong, China
Sponsors and Collaborators
Chinese University of Hong Kong
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Principal Investigator: Leung Ping Chung, MD Dept. of Orthopaedics & Traumatology, CUHK
Wagner EW. Classification of neuropathic foot problems AAOS instructional lecture 28 St. Louis Mosby 1979 p143-165
Brodsky JW. Diabetic Foot Surgery of Foot and Ankle. St. louis Mosby 1992, p1361-1467
Conn, H.M., M.A. and Emmel, V.M. Staining Procedures. Williams and Wilkins Co., Baltimore, 289 pp.m (1960)
Professor P.C. Leung. Limb Salvage for Diabetic ulceration with Traditional Chinese Techniques. Pacific, BioTech News. Vol.1 No.31 1998, Singapore
J.Y.Shi, Collected publications on the applicatioin of Shi's regime for the treatment of diabetic ulcers (in Chinese) special publicaiton on Diabetic Ulcer. Shanghai Research Institute on TCM.

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: The Institute of Chinese Medicine, CUHK Identifier: NCT00393510    
Other Study ID Numbers: CRE-8342
First Posted: October 27, 2006    Key Record Dates
Results First Posted: July 1, 2010
Last Update Posted: July 13, 2010
Last Verified: July 2010
Keywords provided by Chinese University of Hong Kong:
Diabetic Foot Ulcer
Traditional Chinese Medicine
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases