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
Recruitment status was Recruiting
Sponsor:
Guiyang No.1 People's Hospital
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
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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:
- 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
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
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 Ulcer Foot Ulcer Pathologic Processes Foot Diseases Skin Diseases Leg Ulcer Skin Ulcer |
Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases Diabetic Neuropathies |
ClinicalTrials.gov processed this record on May 21, 2013