Trial of Herb Yuyang Ointment to Diabetic Foot Ulcer

The recruitment status of this study is unknown because the information has not been verified recently.

Verified February 2009 by Guiyang No.1 People's Hospital.
Recruitment status was Recruiting

Sponsor:

Collaborators:

Beijing University of Chinese Medicine

Third Military Medical University

Information provided by:

Guiyang No.1 People's Hospital

ClinicalTrials.gov Identifier:

NCT00839865

First received: February 9, 2009

Last updated: NA

Last verified: February 2009

History: No changes posted

Tracking Information

First Received Date ^ICMJE

February 9, 2009

Last Updated Date

February 9, 2009

Start Date ^ICMJE

November 2008

Estimated Primary Completion Date

November 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The primary objective is to determine the effect of this ointment on the incidence of complete wound closure. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Secondary objectives include: evaluating the acceleration of ulcer closure or facilitation of surgical closure, reduction of ulcer surface area over time, reduction in complications, the quality of life and it's safety. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Trial of Herb Yuyang Ointment to Diabetic Foot Ulcer

Official Title ^ICMJE

Phase 1 Study of Herb Yuyang Ointment That Expressed Good Effect in Diabetic Foot Ulcer

Brief Summary

The purpose of this study is to determine if dressing change with a kind of herb Yuyang ointment is clinically more efficacious and safer than Conventional treatment in the treatment of diabetic foot ulcers.

Detailed Description

Developing a Document Retrieval strategy for clinical trials of Chinese medicine treatment of diabetic foot ulcer according to the research program(finished)
Selecting and Evaluating the above trials,developing a methodological quality evaluation criteria(finished)
extract information, verification, meta-analysis, sensitivity analysis and sub-group analysis(finished)
comprehensive evaluating the pros and cons evidences of traditional Chinese medicine, acupuncture and Chinese and Western combined medicine with the treatment of diabetic foot of (finished)
we find dress change with a certain kind of herb ointment is very effective and safe to diabetic foot ulcers.The following step is randomized controlled multicenter clinical trial to verify it's efficacy and safety

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Diabetic Foot Ulcer

Intervention ^ICMJE

Drug: herb ointment

a kind of ointment made from herb

Other Name: TANGZUYUYANGGAO

Study Arm (s)

Experimental: herb ointment dressing change group
This group of patients in the ointment dressing every 2 days until Wound Healing or 6 months

Intervention: Drug: herb ointment
No Intervention: Conventional dressing change group
This group of patients in the Conventional dressing every 2 days until Wound Healing or 6 months

Publications *

Leung PC, Wong MW, Wong WC. Limb salvage in extensive diabetic foot ulceration: an extended study using a herbal supplement. Hong Kong Med J. 2008 Feb;14(1):29-33.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

100

Estimated Completion Date

March 2011

Estimated Primary Completion Date

November 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

In-patient or out-patient patients diagnosed with diabetic foot ulcers
Gangrene or ulceration occurred more than 3 weeks
Over 18 years of age
Gender-open
The type of diabetes (type 1 or type 2) open
Patients receive a written informed consent to participate in the trial

Exclusion Criteria:

Serious complications of heart, liver, lung, kidney damage
Malignant tumors
Allergy for Chinese medicine used
Pregnant women and breast-feeding women

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Li Shufa, Doctor	+86 13885007886	shufali@163.com
Contact: Liu Jianping, Doctor	+86 13718004410	jianping_l@hotmail.com

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT00839865

Other Study ID Numbers ^ICMJE

SFL-2008-11, ISRCTN20081114, NCI-197-4128D, R01-020225-1

Has Data Monitoring Committee

Yes

Responsible Party

Endocrinology Unit, Guiyang No.1 People's Hospital

Study Sponsor ^ICMJE

Guiyang No.1 People's Hospital

Collaborators ^ICMJE

Beijing University of Chinese Medicine
Third Military Medical University

Investigators ^ICMJE

Study Chair:

Li Shufa, doctor

Information Provided By

Guiyang No.1 People's Hospital

Verification Date

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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