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| ID | Type | Description | Link |
|---|---|---|---|
| CGBIOW1404 | Other Grant/Funding Number | CGBIO CO., LTD. |
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The purpose of this study is to test therapeutic benefits of silver dressing compared with non-silver dressing in NPWT(Negative pressure wound therapy). Silver dressing may antibacterial effect on infected diabetes mellitus foot.
Investigator will recruit sixty patients. Participant will be randomly assigned to one of two groups. One is using silver dressing group in NPWT, another is using non-silver dressing group in NPWT. Participant will visit in screening day, NPWT apply day and F/u day for 4 months. Investigators will conduct to check the wound base, Lab, wound culture.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| silver dressing | Experimental | Frequency and duration : 1 change/1day or according to statue of patient Dosage : 1 ea |
|
| non-silver dressing | Active Comparator | Frequency and duration : 1 change/1day or according to statue of patient Dosage : 1 ea |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NPWT application | Device | NPWT mode is cyclic mode : -125~-50 mmHg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Days to patient discharge | -Examine the days from applied medical device to discharge. | up to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Days to infection clearance in wound culture results |
| 4 months (at least once a week for 4 weeks / After dischage, every participant visit day(for 3 months)) |
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Inclusion Criteria:
The patient above 20 years and has type I, II of diabetes mellitus foot ulcer
Infected ulcer has one of below.
clinically infection symptom in ulcer area : warmth, erythema, tenderness/swelling
Confirmed case of bacteria in wound culture.
Conformed case of abnormal range of erythrocyte sedimentation rate (ESR)/C-reactive protein(CRP) level in lab.
Has to be applied NPWT because suture is impossible in ulcer area.
The patient voluntary agreed to this protocol.
In the opinion of investigator, It is suitable to participate in this study.
Exclusion Criteria:
Infection in bone so patient need amputation
Female with childbearing, lactating or not agree to prevent pregnancy.
Has Sepsis, Osteomyelitis
Has Connective tissue disease of disturbance of healing of wound Ex) Rheumarthritis,systemic lupus erythematosus(SEL), myalgia.
The patient to diagnosis of Sickle sell disease or Charcot's joint.
The patient stability treated chronic wasting disease.
Malignant tumor or history of malignant disease. (Not diagnosis of complete recovery.)
The patient treated chemotherapy, radiation therapy, immune-suppressants therapy,adrenocortical hormones therapy.
Although necrosis tissue is removed, the target ulcer did not heal because of gangrenous, necrosis tissue or purulent pyorrhea.
Has ulcer with cardiac arrhythmia thrombus, venous insufficiency, diabetic necrobiosis lipoidic.
In case of using prohibited concomitant medications during study.
a. Oral system steroid b. Immune-suppressive drug c. Unfractionated heparin infusion d. improper drugs in the opinion of investigator.
Hypersensitivity with applicators. (NPWT, Silver)
The patient participated in other clinical trials within 30 days
In the opinion of investigator, the patient is not suitable to participate in this study.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Woo Jin Choi, MD | Contact | 82)2-2228-2195 | choiwj@yuhs.ac | |
| Heiji Han, bachelor | Contact | 82)10-5086-7812 | bohemi_han@naver.com |
| Name | Affiliation | Role |
|---|---|---|
| WooJin Choi, MD | Korea: Severance hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital | Recruiting | Seoul | Seoul | 120-752 | South Korea |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Complete infection clear rate in wound culture results |
|
| up to 4 months |
| Days to complete wound closure | -Examine days from applied medical device to wound closure day | 4 months (at least once a week for 4 weeks / After dischage, every participant visit day(for 3 months)) |
| Wound closure rate |
| up to 4 months |
| Elevation of wound evaluations grade |
| 4 months (at least once a week for 4 weeks / After dischage, every participant visit day(for 3 months)) |
| Days of NPWT application period | -Examine the period of NPWT application | up to 8 weeks |
| Number of surgical debridement after NPWT | -Examine the number of debridement during applied NPWT | up to 8 weeks |
| Lab - deviation of level |
| up to 4 months |
| Rate of adverse event | -Examine adverse event every visit | up to 4 months (if adverse event appeared, Investigator follow until the disappearance of the symptom |