Trial of Herb Yuyang Ointment to Diabetic Foot Ulcer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2011-03-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Diabetic Foot Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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herb ointment dressing change group

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

Group Type EXPERIMENTAL

herb ointment

Intervention Type DRUG

a kind of ointment made from herb

Conventional dressing change group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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herb ointment

a kind of ointment made from herb

Intervention Type DRUG

Other Intervention Names

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TANGZUYUYANGGAO

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No