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| Name | Class |
|---|---|
| Gulou Hospital Affiliated to Medical College of Nanjing University | UNKNOWN |
| Suzhou Municipal Hospital | OTHER |
| Affiliated Hospital of Nantong University | OTHER |
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This study was to investigate the efficacy and safety of Nocardia rubra Cell Wall Skeleton (NCWS) in the treatment of diabetic foot ulcer wounds. The study was a prospective, randomized, controlled, multicentre study . The subjects were randomly divided into two groups: NCWS group and control group(silver ions dressing), with a total of 116 cases and 58 cases in each group. Patients in the NCWS group received nocardia rubra cell wall skeleton for external use, in parallel with silver ions dressing treatment. The efficacy and side effects were observed, with a primary endpoint of 30-days wound healing rate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| N-CWS treatment group | Experimental | Patients with N-CWS treatment |
|
| Control group( treatment with Silver Ion-releasin) | Placebo Comparator | Patients with Silver Ion-releasin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nocardia rubra Cell Wall Skeleton | Drug | Nocardia rubra cell wall skeleton for external application |
|
| Measure | Description | Time Frame |
|---|---|---|
| Wound healing rate up to 30 days | The wound healing rate for 30 days treatment(physiological parameter) | 30 days after first medicine application |
| Measure | Description | Time Frame |
|---|---|---|
| Healing time | The time with complete closure of wound within 30 days treatment | From date medicine application until the complete closure of wound, assessed up to 30 days |
| Healing rate | The rate of complete closure of wound for 30 days treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caiqi Shen | Contact | 86-15062128691 | shencaiqi@163.com | |
| Yixian Shan | Contact | 86-15062121367 | 834093222@qq.com |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| D023801 | Directly Observed Therapy |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| Affiliated Hospital of Jiangnan University |
| OTHER |
| Huai'an First People's Hospital | OTHER |
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| Silver ions dressing | Drug | Silver ions dressing for external application |
|
|
| 30 days after first medicine application |
| Surgical intervention rate | The rate of Surgical intervention for 30 days treatment(physiological parameter) | From first medicine application to 30 days |
| Pathogenic bacteria positive rate | The rate of Pathogenic bacteria positive for 30 days treatment(physiological parameter) | 30 days after first medicine application |
| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
| D055118 | Medication Adherence |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D008722 | Methods |