Trial of Herb Yuyang Ointment to Diabetic Foot Ulcer

Study Overview
=================
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

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

Conditions
-----------------
Diabetic Foot Ulcer

Intervention / Treatment
-----------------
* Drug: herb ointment


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: herb ointment dressing change group<br>This group of patients in the ointment dressing every 2 days until Wound Healing or 6 months | Drug: herb ointment<br>* a kind of ointment made from herb<br>* Other names: TANGZUYUYANGGAO;|
| No Intervention: Conventional dressing change group<br>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 | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective is to determine the effect of this ointment on the incidence of complete wound closure. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Evidence-based evaluation, Multi-center randomized controlled clinical trials, Traditional Chinese Medicine, therapy, diabetic foot ulcer, clinical trails