NCT00393510

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2000

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2000

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 27, 2006

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

July 1, 2010

Completed
Last Updated

July 13, 2010

Status Verified

July 1, 2010

Enrollment Period

5.3 years

First QC Date

October 26, 2006

Results QC Date

November 23, 2009

Last Update Submit

July 6, 2010

Conditions

Diabetic Foot UlcerAmputation

Keywords

Diabetic Foot UlcerTraditional Chinese Medicine

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Limb Salvage

    The number of successful limb rescued (without amputation).

    24 weeks

Secondary Outcomes (2)

  • Tumour Necrosis Factor-alpha Levels in Serum

    Baseline and 4 week

  • Time of Ulcer Healing

    24 week

Study Arms (2)

Traditional Chinese Medicine

ACTIVE COMPARATOR

12 herbals formulation was given as an adjuvant therapy for the patients orally twice a day.

Drug: TCM

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

TCMDRUG

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

Traditional Chinese Medicine
PlaceboDRUG

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.

Placebo

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Orthopaedics & Traumatology, Prince of Wales hospital

Hong Kong, China

Location

Department of Orthopaedics and Traumatology, Kwong Wah Hospital

Hong Kong, China

Location

Related Publications (17)

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

    PMID: 8110884BACKGROUND

  • 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.

    PMID: 8508618BACKGROUND

  • 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.

    PMID: 1468291BACKGROUND

  • 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.

    PMID: 7983528BACKGROUND

  • 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.

    PMID: 9501573BACKGROUND

  • 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.

    PMID: 7513041BACKGROUND

  • 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.

    PMID: 9380770BACKGROUND

  • 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.

    PMID: 8601643BACKGROUND

  • 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.

    PMID: 9069565BACKGROUND

  • 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.

    PMID: 9516057BACKGROUND

  • 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.

    PMID: 8581471BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 22463944DERIVED

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Results Point of Contact

Title
Prof. Leung Ping Chung
Organization
Institute of Chinese Medicine, Chinese University of Hong Kong
pingcleung@cuhk.edu.hk
(852)2252 8863

Study Officials

  • Leung Ping Chung, MD

    Dept. of Orthopaedics & Traumatology, CUHK

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 26, 2006

First Posted

October 27, 2006

Study Start

November 1, 2000

Primary Completion

March 1, 2006

Study Completion

March 1, 2006

Last Updated

July 13, 2010

Results First Posted

July 1, 2010

Record last verified: 2010-07

Locations

CN(2)