Herbal Preparation Used as Adjuvant Therapy on Diabetic Ulcers
Primary Purpose
Diabetic Foot Ulcer, Amputation
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
TCM
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Foot Ulcer focused on measuring Diabetic Foot Ulcer, Traditional Chinese Medicine
Eligibility Criteria
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
Sites / Locations
- Department of Orthopaedics & Traumatology, Prince of Wales hospital
- Department of Orthopaedics and Traumatology, Kwong Wah Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Traditional Chinese Medicine
Placebo
Arm Description
12 herbals formulation was given as an adjuvant therapy for the patients orally twice a day.
Placebo was made with starch and colouring materials. Given to patient orally twice a day
Outcomes
Primary Outcome Measures
Number of Participants With Limb Salvage
The number of successful limb rescued (without amputation).
Secondary Outcome Measures
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 of Ulcer Healing
Time taken for maturation of granulation to enable skin grafting.
Full Information
NCT ID
NCT00393510
First Posted
October 26, 2006
Last Updated
July 6, 2010
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT00393510
Brief Title
Herbal Preparation Used as Adjuvant Therapy on Diabetic Ulcers
Official Title
An Evidence Base Study on the Clinical Effects of Integrated Western Medicine and Traditional Chinese Medicine for Diabetic Foot Ulcer Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
November 2000 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
March 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer, Amputation
Keywords
Diabetic Foot Ulcer, Traditional Chinese Medicine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Traditional Chinese Medicine
Arm Type
Active Comparator
Arm Description
12 herbals formulation was given as an adjuvant therapy for the patients orally twice a day.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo was made with starch and colouring materials. Given to patient orally twice a day
Intervention Type
Drug
Intervention Name(s)
TCM
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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 Measure Information:
Title
Number of Participants With Limb Salvage
Description
The number of successful limb rescued (without amputation).
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Tumour Necrosis Factor-alpha Levels in Serum
Description
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
Title
Time of Ulcer Healing
Description
Time taken for maturation of granulation to enable skin grafting.
Time Frame
24 week
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leung Ping Chung, MD
Organizational Affiliation
Dept. of Orthopaedics & Traumatology, CUHK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Orthopaedics & Traumatology, Prince of Wales hospital
City
Hong Kong
Country
China
Facility Name
Department of Orthopaedics and Traumatology, Kwong Wah Hospital
City
Hong Kong
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
8110884
Citation
Levin ME. Diabetic foot ulcers: pathogenesis and management. J ET Nurs. 1993 Sep-Oct;20(5):191-8.
Results Reference
background
PubMed Identifier
8508618
Citation
Nelzen 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. doi: 10.1111/j.1464-5491.1993.tb00077.x.
Results Reference
background
PubMed Identifier
1468291
Citation
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.
Results Reference
background
PubMed Identifier
7983528
Citation
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.
Results Reference
background
PubMed Identifier
9501573
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.
Results Reference
background
PubMed Identifier
7513041
Citation
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.
Results Reference
background
PubMed Identifier
9380770
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. doi: 10.1159/000139492.
Results Reference
background
PubMed Identifier
8601643
Citation
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.
Results Reference
background
PubMed Identifier
9069565
Citation
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.
Results Reference
background
PubMed Identifier
9516057
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. doi: 10.1055/s-0029-1211947.
Results Reference
background
PubMed Identifier
8581471
Citation
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.
Results Reference
background
Citation
Wagner EW. Classification of neuropathic foot problems AAOS instructional lecture 28 St. Louis Mosby 1979 p143-165
Results Reference
background
Citation
Brodsky JW. Diabetic Foot Surgery of Foot and Ankle. St. louis Mosby 1992, p1361-1467
Results Reference
background
Citation
Conn, H.M., M.A. and Emmel, V.M. Staining Procedures. Williams and Wilkins Co., Baltimore, 289 pp.m (1960)
Results Reference
background
Citation
Professor P.C. Leung. Limb Salvage for Diabetic ulceration with Traditional Chinese Techniques. Pacific, BioTech News. Vol.1 No.31 1998, Singapore
Results Reference
background
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.
Results Reference
background
PubMed Identifier
22463944
Citation
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.
Results Reference
derived
Learn more about this trial
Herbal Preparation Used as Adjuvant Therapy on Diabetic Ulcers
We'll reach out to this number within 24 hrs