drugset / Trial / NCT00393510
Herbal Preparation Used as Adjuvant Therapy on Diabetic Ulcers
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2000-11
- Primary completion
- 2006-03
- Completion
- 2006-03
Publications
- Background Levin ME. Diabetic foot ulcers: pathogenesis and management. J ET Nurs. 1993 Sep-Oct;20(5):191-8.
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- Background 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. doi: 10.2337/diacare.15.11.1598.
- Background 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. doi: 10.1152/jn.1994.72.2.684.
- Background 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.
- Background 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. doi: 10.1016/0169-328x(94)90391-3.
- Background 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. doi: 10.1159/000139492.
- Background Kunjathoor VV, Wilson DL, LeBoeuf RC. Increased atherosclerosis in streptozotocin-induced diabetic mice. J Clin Invest. 1996 Apr 1;97(7):1767-73. doi: 10.1172/JCI118604.
- Background Liu S, Barac-Nieto M. Renal protein degradation in streptozotocin diabetic mice. Diabetes Res Clin Pract. 1997 Jan;34(3):143-8. doi: 10.1016/s0168-8227(96)01353-8.
- Background 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. doi: 10.1055/s-0029-1211947.
- Background 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. doi: 10.1016/0006-8993(95)00876-r.
- Background Wagner EW. Classification of neuropathic foot problems AAOS instructional lecture 28 St. Louis Mosby 1979 p143-165
- Background Brodsky JW. Diabetic Foot Surgery of Foot and Ankle. St. louis Mosby 1992, p1361-1467
- Background Conn, H.M., M.A. and Emmel, V.M. Staining Procedures. Williams and Wilkins Co., Baltimore, 289 pp.m (1960)
- Background Professor P.C. Leung. Limb Salvage for Diabetic ulceration with Traditional Chinese Techniques. Pacific, BioTech News. Vol.1 No.31 1998, Singapore
- Background 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.
- Leung PC, Pang SY, Wong EL, Cheng KF. Inflammatory state of type II diabetic patients with chronic ulcers in response to herbal treatment. Foot (Edinb). 2012 Sep;22(3):181-5. doi: 10.1016/j.foot.2012.03.001. Epub 2012 Mar 30.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | TCM | Unknown | — | Oral |