Herbal Preparation Used as Adjuvant Therapy on Diabetic Ulcers

Diabetic Foot Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00393510
• Other study ID #: CRE-8342
• Status: Completed
• Phase: Phase 2
• First received: October 26, 2006
• Last updated: July 6, 2010
• Start date: November 2000
• Est. completion date: March 2006

Study information

• Verified date: July 2010
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Amputation
• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

Intervention

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
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.

Locations

Country	Name	City	State
China	Department of Orthopaedics & Traumatology, Prince of Wales hospital	Hong Kong
China	Department of Orthopaedics and Traumatology, Kwong Wah Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

References & Publications (16)

Ahlgren SC, Levine JD. Protein kinase C inhibitors decrease hyperalgesia and C-fiber hyperexcitability in the streptozotocin-diabetic rat. J Neurophysiol. 1994 Aug;72(2):684-92. — View Citation

Bazan NG, Gordon WC, Marcheselli VL, Lukiw WJ, Duhault J, Koenig-Berard E, Linn DM, DeCoster MA, Mukherjee PK. Experimental models and their use in studies of diabetic retinal microangiopathy. Therapie. 1997 Sep-Oct;52(5):447-51. — View Citation

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)

Diemel LT, Brewster WJ, Fernyhough P, Tomlinson DR. Expression of neuropeptides in experimental diabetes; effects of treatment with nerve growth factor or brain-derived neurotrophic factor. Brain Res Mol Brain Res. 1994 Jan;21(1-2):171-5. — View Citation

Follansbee MH, Beyer KH Jr, Griffith JW, Vesell ES. Studies on pyrazinoylguanidine. 5. Temporal effects over 24 weeks demonstrating attenuation of diabetic nephropathy in STZ-diabetic rats. Pharmacology. 1997 May;54(5):241-55. — View Citation

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.

Kunjathoor VV, Wilson DL, LeBoeuf RC. Increased atherosclerosis in streptozotocin-induced diabetic mice. J Clin Invest. 1996 Apr 1;97(7):1767-73. — View Citation

Levin ME. Diabetic foot ulcers: pathogenesis and management. J ET Nurs. 1993 Sep-Oct;20(5):191-8. — View Citation

Liu S, Barac-Nieto M. Renal protein degradation in streptozotocin diabetic mice. Diabetes Res Clin Pract. 1997 Jan;34(3):143-8. — View Citation

Mavrikakis ME, Sfikakis PP, Kontoyannis D, Horti M, Kittas C, Koutras DA, Raptis SA. Macrovascular disease of coronaries and cerebral arteries in streptozotocin-induced diabetic rats. A controlled, comparative study. Exp Clin Endocrinol Diabetes. 1998;106(1):35-40. — View Citation

Nelzén O, Bergqvist D, Lindhagen A. High prevalence of diabetes in chronic leg ulcer patients: a cross-sectional population study. Diabet Med. 1993 May;10(4):345-50. — View Citation

Professor P.C. Leung. Limb Salvage for Diabetic ulceration with Traditional Chinese Techniques. Pacific, BioTech News. Vol.1 No.31 1998, Singapore

Steed DL, Goslen JB, Holloway GA, Malone JM, Bunt TJ, Webster MW. Randomized prospective double-blind trial in healing chronic diabetic foot ulcers. CT-102 activated platelet supernatant, topical versus placebo. Diabetes Care. 1992 Nov;15(11):1598-604. — View Citation

Wagner EW. Classification of neuropathic foot problems AAOS instructional lecture 28 St. Louis Mosby 1979 p143-165

Zochodne DW, Murray MM, van der Sloot P, Riopelle RJ. Distal tibial mononeuropathy in diabetic and nondiabetic rats reared on wire cages: an experimental entrapment neuropathy. Brain Res. 1995 Nov 6;698(1-2):130-6. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Limb Salvage	The number of successful limb rescued (without amputation).	24 weeks	No
Secondary	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.	Baseline and 4 week	No
Secondary	Time of Ulcer Healing	Time taken for maturation of granulation to enable skin grafting.	24 week	No