Diabetic Foot Ulcer
Conditions
Keywords
Evidence-based evaluation, Multi-center randomized controlled clinical trials, Traditional Chinese Medicine, therapy, diabetic foot ulcer, clinical trails
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
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
Interventions
DRUGherb ointment
a kind of ointment made from herb
Sponsors
Beijing University of Chinese Medicine
Third Military Medical University
Guiyang No.1 People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to determine the effect of this ointment on the incidence of complete wound closure. | 6 months |
Secondary
| 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. | 6 months |
Countries
China
Contacts
Primary ContactLi Shufa, Doctor
Backup ContactLiu Jianping, Doctor
Outcome results
None listed