Trial of Herb Yuyang Ointment to Diabetic Foot Ulcer

February 9, 2009 updated by: Guiyang No.1 People's Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guizhou
      • Guiyang, Guizhou, China, 550002
        • Recruiting
        • endocrinology unit,No.1 people's hospital of Guiyang City
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • TANGZUYUYANGGAO
No Intervention: Conventional dressing change group
This group of patients in the Conventional dressing every 2 days until Wound Healing or 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary objective is to determine the effect of this ointment on the incidence of complete wound closure.
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guiyang No.1 People's Hospital

Collaborators

Third Military Medical University
Beijing University of Chinese Medicine

Investigators

  • Study Chair: Li Shufa, doctor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Anticipated)

November 1, 2010

Study Completion (Anticipated)

March 1, 2011

Study Registration Dates

First Submitted

February 9, 2009

First Submitted That Met QC Criteria

February 9, 2009

First Posted (Estimate)

February 10, 2009

Study Record Updates

Last Update Posted (Estimate)

February 10, 2009

Last Update Submitted That Met QC Criteria

February 9, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SFL-2008-11
  • ISRCTN20081114
  • NCI-197-4128D
  • R01-020225-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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