Trial of Herb Yuyang Ointment to Diabetic Foot Ulcer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00839865
Recruitment Status : Unknown
Verified February 2009 by Guiyang No.1 People's Hospital.
Recruitment status was:  Recruiting
First Posted : February 10, 2009
Last Update Posted : February 10, 2009
Beijing University of Chinese Medicine
Third Military Medical University
Information provided by:
Guiyang No.1 People's Hospital

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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Drug: herb ointment Phase 2

Expanded Access : Guiyang No.1 People's Hospital has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Detailed Description:
  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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Study of Herb Yuyang Ointment That Expressed Good Effect in Diabetic Foot Ulcer
Study Start Date : November 2008
Estimated Primary Completion Date : November 2010
Estimated Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: herb ointment dressing change group
This group of patients in the ointment dressing every 2 days until Wound Healing or 6 months
Drug: herb ointment
a kind of ointment made from herb

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

Primary Outcome Measures :
  1. The primary objective is to determine the effect of this ointment on the incidence of complete wound closure. [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00839865

Contact: Li Shufa, Doctor +86 13885007886
Contact: Liu Jianping, Doctor +86 13718004410

China, Guizhou
endocrinology unit,No.1 people's hospital of Guiyang City Recruiting
Guiyang, Guizhou, China, 550002
Contact: Li ShuFa, Doctor    +86 0851 5833059   
Contact: Liu JianPing, Doctor    +86 13718004410   
Sponsors and Collaborators
Guiyang No.1 People's Hospital
Beijing University of Chinese Medicine
Third Military Medical University
Study Chair: Li Shufa, doctor

Responsible Party: Endocrinology Unit, Guiyang No.1 People's Hospital Identifier: NCT00839865     History of Changes
Other Study ID Numbers: SFL-2008-11
First Posted: February 10, 2009    Key Record Dates
Last Update Posted: February 10, 2009
Last Verified: February 2009

Keywords provided by Guiyang No.1 People's Hospital:
Evidence-based evaluation
Multi-center randomized controlled clinical trials
Traditional Chinese Medicine
diabetic foot ulcer
clinical trails

Additional relevant MeSH terms:
Diabetic Foot
Foot Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases