Diabetes MellitusPhase 4NPWT-silverNCT02274207
Comparative Study of Antibacterial Effect on Silver Dressing of Negative Pressure Wound
A Phase 4 study testing NPWT application in people with Diabetes Mellitus, run by Severance Hospital at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- NPWT application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2014to Aug 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- induration, purulent discharge etc.
- Confirmed case of bacteria in wound culture.
- Conformed case of abnormal range of erythrocyte sedimentation rate (ESR)/C-reactive protein(CRP) level in lab.
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- 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.
Who cannot join
- 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.
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- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Severance Hospital
Seoul, Seoul, 120-752
Woojin Choi, MD, 82)2-2228-2195, choiwj@yuhs.ac
Heiji Han, bechelor, 82)2-2228-2195, bohemi_han@naver.com
About this study
Official title: Phase IV Study of Antibacterial Effect on Silver Dressing of NPWT
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.
Read the detailed description
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.
- Conditions
- Diabetes Mellitus
- Being tested
- NPWT application
- Keywords
- Silver dressing, NPWT, DMF, foot
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NPWT applicationDevice
NPWT mode is cyclic mode : -125~-50 mmHg
| Study group | Role | What they receive |
|---|---|---|
| silver dressing | Experimental | Frequency and duration : 1 change/1day or according to statue of patient Dosage : 1 ea Receives: Device: NPWT application |
| non-silver dressing | Active comparator | Frequency and duration : 1 change/1day or according to statue of patient Dosage : 1 ea Receives: Device: NPWT application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days to patient discharge
-Examine the days from applied medical device to discharge.
Measured: up to 4 weeks
Secondary outcomes (9)
Days to infection clearance in wound culture results
- Compare screening culture test with every visit culture test
- Examine days to infection clearance(point to show bacteria minus level in culture test)
Measured: 4 months (at least once a week for 4 weeks / After dischage, every participant visit day(for 3 months))
Complete infection clear rate in wound culture results
- Compare screening culture test with every visit culture test
- Examine total complete infection clear rate in each groups. (point to show bacteria minus level in culture test)
Measured: up to 4 months
Days to complete wound closure
-Examine days from applied medical device to wound closure day
Measured: 4 months (at least once a week for 4 weeks / After dischage, every participant visit day(for 3 months))
Wound closure rate
- Examine total wound closure rate in each groups.
- Wound closure: definition: skin graft, epithelized skin or simple suture et. al.
Measured: up to 4 months
Elevation of wound evaluations grade
- Examine the rate of wound size, wound depth (4 category),granulation tissue grade (5 step),Infection symptom(4 grade)
- Present wound size, infection grade, depth category, granulation tissue grade at every patient visit and examine elevation of wound evaluations compared with baseline.
Measured: 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
Measured: up to 8 weeks
Number of surgical debridement after NPWT
-Examine the number of debridement during applied NPWT
Measured: up to 8 weeks
Lab - deviation of level
- Compared baseline lab level
- Examine related infection sign level (white blood cell,monocytes,C-reactive protein)
- Finding adverse deviation level through the lab level
Measured: up to 4 months
Rate of adverse event
-Examine adverse event every visit
Measured: up to 4 months (if adverse event appeared, Investigator follow until the disappearance of the symptom
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2014 (estimated)
- Study startDec 2014
- Primary completionMay 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Woojin Choi, Severance Hospital
- Investigators
- WooJin Choi, MD, Principal investigator, Korea: Severance hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02274207
- Sponsor's protocol ID
- SS-14-NPWT
- Other IDs
- CGBIOW1404
- Acronym
- NPWT-silver
- Status last verified
- Nov 2015
- First submitted
- 2 Sep 2014
- Last updated
- 24 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Study of Antibacterial Effect on Silver Dressing of NPWT
- ClinicalTrials.gov ID
- NCT02274207
- Acronym / sponsor ID
- NPWT-silver / SS-14-NPWT
- Conditions
- Diabetes Mellitus
- Keywords
- Silver dressing, NPWT, DMF, foot
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Severance HospitalUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- May 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 24 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| silver dressing | Experimental | Device: NPWT applicationFrequency and duration : 1 change/1day or according to statue of patient Dosage : 1 ea |
| non-silver dressing | Active comparator | Device: NPWT applicationFrequency and duration : 1 change/1day or according to statue of patient Dosage : 1 ea |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The patient above 20 years and has type I, II of diabetes mellitus foot ulcer
- Infected ulcer has one of below.
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NPWT applicationNPWT mode is cyclic mode : -125~-50 mmHg | Device | non-silver dressing, silver dressing |
Primary outcome
Days to patient discharge
Time frame: up to 4 weeks
-Examine the days from applied medical device to discharge.
9 secondary outcomes
Days to infection clearance in wound culture results
Time frame: 4 months (at least once a week for 4 weeks / After dischage, every participant visit day(for 3 months))
Complete infection clear rate in wound culture results
Time frame: up to 4 months
Days to complete wound closure
Time frame: 4 months (at least once a week for 4 weeks / After dischage, every participant visit day(for 3 months))
Wound closure rate
Time frame: up to 4 months
Elevation of wound evaluations grade
Time frame: 4 months (at least once a week for 4 weeks / After dischage, every participant visit day(for 3 months))
Days of NPWT application period
Time frame: up to 8 weeks
Number of surgical debridement after NPWT
Time frame: up to 8 weeks
Lab - deviation of level
Time frame: up to 4 months
Rate of adverse event
Time frame: up to 4 months (if adverse event appeared, Investigator follow until the disappearance of the symptom
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
WooJin Choi, MD principal investigator
Korea: Severance hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing NPWT application in people with Diabetes Mellitus, run by Severance Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Woo Jin Choi, MD (82)2-2228-2195, choiwj@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days to patient discharge (time frame: up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2015.