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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

February 9, 2009
February 9, 2009
November 2008
November 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
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 ]
Same as current
Not Provided
Not Provided
 
Trial of Herb Yuyang Ointment to Diabetic Foot Ulcer
Phase 1 Study of Herb Yuyang Ointment That Expressed Good Effect in Diabetic Foot Ulcer

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.

  1. Developing a Document Retrieval strategy for clinical trials of Chinese medicine treatment of diabetic foot ulcer according to the research program(finished)
  2. Selecting and Evaluating the above trials,developing a methodological quality evaluation criteria(finished)
  3. extract information, verification, meta-analysis, sensitivity analysis and sub-group analysis(finished)
  4. 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)
  5. 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
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetic Foot Ulcer
Drug: herb ointment
a kind of ointment made from herb
Other Name: TANGZUYUYANGGAO
  • 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
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.
 
Recruiting
100
March 2011
November 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Li Shufa, Doctor +86 13885007886 shufali@163.com
Contact: Liu Jianping, Doctor +86 13718004410 jianping_l@hotmail.com
China
 
NCT00839865
SFL-2008-11, ISRCTN20081114, NCI-197-4128D, R01-020225-1
Yes
Endocrinology Unit, Guiyang No.1 People's Hospital
Guiyang No.1 People's Hospital
  • Beijing University of Chinese Medicine
  • Third Military Medical University
Study Chair: Li Shufa, doctor
Guiyang No.1 People's Hospital
February 2009

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