Trial of Herb Yuyang Ointment to Diabetic Foot Ulcer
Phase 1 Study of Herb Yuyang Ointment That Expressed Good Effect in Diabetic Foot Ulcer
4 other identifiers
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 9, 2009
CompletedFirst Posted
Study publicly available on registry
February 10, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedFebruary 10, 2009
February 1, 2009
2 years
February 9, 2009
February 9, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary objective is to determine the effect of this ointment on the incidence of complete wound closure.
6 months
Secondary Outcomes (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.
6 months
Study Arms (2)
herb ointment dressing change group
EXPERIMENTALThis group of patients in the ointment dressing every 2 days until Wound Healing or 6 months
Conventional dressing change group
NO INTERVENTIONThis group of patients in the Conventional dressing every 2 days until Wound Healing or 6 months
Interventions
a kind of ointment made from herb
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Serious complications of heart, liver, lung, kidney damage
- Malignant tumors
- Allergy for Chinese medicine used
- Pregnant women and breast-feeding women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Guiyang No.1 People's Hospitallead
- Beijing University of Chinese Medicinecollaborator
- Third Military Medical Universitycollaborator
Study Sites (1)
endocrinology unit,No.1 people's hospital of Guiyang City
Guiyang, Guizhou, 550002, China
Related 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.
PMID: 18239240BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Li Shufa, doctor
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Expanded Access
- Yes
Study Record Dates
First Submitted
February 9, 2009
First Posted
February 10, 2009
Study Start
November 1, 2008
Primary Completion
November 1, 2010
Study Completion
March 1, 2011
Last Updated
February 10, 2009
Record last verified: 2009-02