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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
  Purpose

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 Intervention Phase
Diabetic Foot Ulcer
Drug: herb ointment
Phase 2

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1 Study of Herb Yuyang Ointment That Expressed Good Effect in Diabetic Foot Ulcer

Resource links provided by NLM:


Further study details as provided by Guiyang No.1 People's Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
Study Start Date: November 2008
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: TANGZUYUYANGGAO
No Intervention: Conventional dressing change group
This group of patients in the Conventional dressing every 2 days until Wound Healing or 6 months

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00839865

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

Locations
China, Guizhou
endocrinology unit,No.1 people's hospital of Guiyang City Recruiting
Guiyang, Guizhou, China, 550002
Contact: Li ShuFa, Doctor    +86 0851 5833059    shufali@163.com   
Contact: Liu JianPing, Doctor    +86 13718004410    jianping_l@hotmail.com   
Sponsors and Collaborators
Guiyang No.1 People's Hospital
Beijing University of Chinese Medicine
Third Military Medical University
Investigators
Study Chair: Li Shufa, doctor
  More Information

Publications:
Responsible Party: Endocrinology Unit, Guiyang No.1 People's Hospital
ClinicalTrials.gov Identifier: NCT00839865     History of Changes
Other Study ID Numbers: SFL-2008-11, ISRCTN20081114, NCI-197-4128D, R01-020225-1
Study First Received: February 9, 2009
Last Updated: February 9, 2009
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on November 24, 2014