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This project is based on investigator team's ten year experience on diabetic ulcer and goes on further developing basic research and concluding clinical experience. The investigator team has recently developed "Remove stasis to generate granulation tissue" into "Remove slough to generate granulation tissue". Investigators have applied the principle of "Remove stasis" in the medium and later stage of treatment to make "Remove slough-Eliminate stasis-Generate granulation tissue" become the basic principle of three-stage sequential treatment. Investigators will further conclude Chinese medicine therapy in the stage of "Qing-Hua-Bu" and evaluate safety, applicability and availability of it. Therefore, the research can help improve clinical diagnosis and treatment technique and transfer the study result of Chinese medicine experience on diabetic ulcer.
Aim: Under guidance of "Clear pus-Remove stasis-Supplement muscles" theory, to observe clinical effectiveness of dynamic Chinese external therapy of "Qing-Hua-Bu" in treating diabetic ulcer and partially explain potential wound healing mechanism.
Method: Clinical observation: To adopt the design method of open and parallel control test and include 150 diabetic ulcer patients. The treatment group was supplied with external clearing heat, removing stasis and supplementing deficiency Chinese medicine, while the control group was supplied with sulfadiazine silver cream, furacilin solution and bovine basic fibroblast growth factors (b-FGF) spray. To perform the dressing change for wound every day and persist in dressing change for two months. To record dynamic wound healing progress by digital camera. After finishing course, to compare wound healing, pus, exudate, granulation tissues and epithelial tissues and analyze these data by SPSS22.0.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| External Chinese medicine | Experimental | External Chinese medicine include 3 kinds of formula,including: Qin, Hua and Bu will be applied to cover the participants' lesions in wet dressing form. Dosage form:5g/ml; frequency:qd; duration:2months. |
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| External Western medicine | Active Comparator | Ethacridine Lactate Solution, 1% Sulfadiazine Silver Cream and rb-bFGF will be applied to cover the participants' lesions. Dosage form:3g/ml; frequency:qd; duration: 2months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| External Chinese medicine | Drug | External Chinese medicine: For patients in the treatment group, they will accept one of three specific External Chinese medicine according to their lesions and corresponding syndromes:
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| Measure | Description | Time Frame |
|---|---|---|
| Wound healing rate | To perform the dressing change for wound every day and persist in dressing change for two months. To record dynamic wound healing progress by digital camera. After finishing course, to compare wound healing, pus, exudate, granulation tissues and epithelial tissues and analyze these data by SPSS22.0. | up to 56 days after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fulun Li | Contact | 0086-021-65162629 | drlifulun@163.com | |
| Minfeng Wu | Contact | 0086-021-50690332 | 996392167@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Jia Zhou | Department of dermatology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai | Study Chair |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| D012883 | Skin Ulcer |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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| External Western medicine | Drug | For patients in the control group, they will accept one of three specific external Western medicine according to their lesions: 1.Ethacridine Lactate Solution(lesions with much effusion); 2.1% Sulfadiazine Silver Cream(lesions with infection); 3.rb-bFGF(lesions with no slough and look clear). |
|
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| D007871 |
| Leg Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |