Trial of Herb Yuyang Ointment to Diabetic Foot Ulcer

Diabetic Foot Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00839865
• Other study ID #: SFL-2008-11
• Secondary ID: ISRCTN20081114NC
• Status: Recruiting
• Phase: Phase 2
• First received: February 9, 2009
• Last updated: February 9, 2009
• Start date: November 2008
• Est. completion date: March 2011

Study information

• Verified date: February 2009
• Source: Guiyang No.1 People's Hospital
• Contact: Li Shufa, Doctor
• Phone: +86 13885007886
• Email: shufali[@]163.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

Intervention

Drug:
• herb ointment
a kind of ointment made from herb

Locations

Country	Name	City	State
China	endocrinology unit,No.1 people's hospital of Guiyang City	Guiyang	Guizhou

Sponsors (3)

Lead Sponsor	Collaborator
Guiyang No.1 People's Hospital	Beijing University of Chinese Medicine, Third Military Medical University

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary objective is to determine the effect of this ointment on the incidence of complete wound closure.		6 months	Yes
Secondary	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.		6 months	Yes