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Trial of Herb Yuyang Ointment to Diabetic Foot Ulcer

Primary Purpose

Diabetic Foot Ulcer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
herb ointment
Sponsored by
Guiyang No.1 People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcer focused on measuring Evidence-based evaluation, Multi-center randomized controlled clinical trials, Traditional Chinese Medicine, therapy, diabetic foot ulcer, clinical trails

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • endocrinology unit,No.1 people's hospital of Guiyang CityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

herb ointment dressing change group

Conventional dressing change group

Arm Description

This group of patients in the ointment dressing every 2 days until Wound Healing or 6 months

This group of patients in the Conventional dressing every 2 days until Wound Healing or 6 months

Outcomes

Primary Outcome Measures

The primary objective is to determine the effect of this ointment on the incidence of complete wound closure.

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.

Full Information

First Posted
February 9, 2009
Last Updated
February 9, 2009
Sponsor
Guiyang No.1 People's Hospital
Collaborators
Beijing University of Chinese Medicine, Third Military Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT00839865
Brief Title
Trial of Herb Yuyang Ointment to Diabetic Foot Ulcer
Official Title
Phase 1 Study of Herb Yuyang Ointment That Expressed Good Effect in Diabetic Foot Ulcer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Unknown status
Study Start Date
November 2008 (undefined)
Primary Completion Date
November 2010 (Anticipated)
Study Completion Date
March 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Guiyang No.1 People's Hospital
Collaborators
Beijing University of Chinese Medicine, Third Military Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer
Keywords
Evidence-based evaluation, Multi-center randomized controlled clinical trials, Traditional Chinese Medicine, therapy, diabetic foot ulcer, clinical trails

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
herb ointment dressing change group
Arm Type
Experimental
Arm Description
This group of patients in the ointment dressing every 2 days until Wound Healing or 6 months
Arm Title
Conventional dressing change group
Arm Type
No Intervention
Arm Description
This group of patients in the Conventional dressing every 2 days until Wound Healing or 6 months
Intervention Type
Drug
Intervention Name(s)
herb ointment
Other Intervention Name(s)
TANGZUYUYANGGAO
Intervention Description
a kind of ointment made from herb
Primary Outcome Measure Information:
Title
The primary objective is to determine the effect of this ointment on the incidence of complete wound closure.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li Shufa, Doctor
Phone
+86 13885007886
Email
shufali@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Liu Jianping, Doctor
Phone
+86 13718004410
Email
jianping_l@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Shufa, doctor
Official's Role
Study Chair
Facility Information:
Facility Name
endocrinology unit,No.1 people's hospital of Guiyang City
City
Guiyang
State/Province
Guizhou
ZIP/Postal Code
550002
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li ShuFa, Doctor
Phone
+86 0851 5833059
Email
shufali@163.com
First Name & Middle Initial & Last Name & Degree
Liu JianPing, Doctor
Phone
+86 13718004410
Email
jianping_l@hotmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
18239240
Citation
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.
Results Reference
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Trial of Herb Yuyang Ointment to Diabetic Foot Ulcer

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