Pressure UlcerNCT02007824
Clinical Trial to Evaluate Ultrasonic Surgical Device in Chronic Pressure Ulcer
A study testing ULSD-12D and SONOCA-180 in people with Pressure Ulcer and Wound, run by Seoul National University Hospital at 3 sites in South Korea.
Trial summary
Study objective The purpose of this trial is to evaluate the efficacy and safety of the investigational device, ULSD-12D, as Compared to the comparator, SONOCA-180, in chronic wound. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Pressure Ulcer, Wound, Necrosis
- What is being tested?
- ULSD-12D and SONOCA-180
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesSouth Korea
- Study dates
- Aug 2013to Mar 2014
- Phase
- Interventional
- 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
- over 20 years of age
- subject who has untreated wounds
- subject who has wound size over 3cm x 3cm
- subject who has wound over stage 2
Who cannot join
- cellulitis
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
Samsung Medical Center
Seoul, Gangnam-gu, 135-710
Hanyang University Hospital
Seoul, Seongdong-gu, 133-791
About this study
Official title: Clinical Trial to Evaluate Efficacy and Safety of Ultrasonic Surgical Device (ULSC-12D)in Chronic Pressure Ulcer
Study objective The purpose of this trial is to evaluate the efficacy and safety of the investigational device, ULSD-12D, as Compared to the comparator, SONOCA-180, in chronic wound.
Read the detailed description
- Study design Multi-center, randomized clinical trial
- Study population Adults with chronic wound
- Investigational device treatment procedure Before Treatment: The subject's eligibility (inclusion/exclusion criteria) will be assessed,and apply the Study Device or Comparator on their wound in a randomized manner. Post-Treatment: All subjects will take pictures of the wound area and measured the number of microorganism and wound size.
- Conditions
- Pressure Ulcer, Wound, Necrosis
- Being tested
- ULSD-12D, SONOCA-180
- Keywords
- pressure ulcer, chronic wound, tissue necrosis, slough, ultra sound
- Medical subject headings
- Pressure Ulcer, Wounds and Injuries, Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ULSD-12DDevice
wound cleansing and debridement using ULSD-12D
SONOCA-180Device
wound cleansing and debridement using SONOCA-180
| Study group | Role | What they receive |
|---|---|---|
| ULSD-12D | Experimental | ultrasound surgical device made by Ultech. Receives: Device: ULSD-12D |
| SONOCA-180 | Active comparator | ultrasound surgical device made by Soering Receives: Device: SONOCA-180 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of microorganisms on wound bed
Investigator measured the number of microorganisms on wound bed at pre and post debridement using nitrocellulose filter.
Measured: Baseline and 30minuts post debridement
Secondary outcomes (1)
necrotic tissue region
Area calculation of necrotic tissue region at pre and post debridement
Measured: Baseline and 30minuts post debridement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startAug 2013
- Primary completionFeb 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure UlcerStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chan-Yeong Heo, Seoul National University Hospital
- Investigators
- Chanyeong - Heo, Ph.D, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02007824
- Sponsor's protocol ID
- 08-2013-020
- Other IDs
- ULSC-12D
- Status last verified
- Apr 2014
- First submitted
- 31 Oct 2013
- Last updated
- 7 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Evaluate Efficacy and Safety of Ultrasonic Surgical Device (ULSC-12D)in Chronic Pressure Ulcer
- ClinicalTrials.gov ID
- NCT02007824
- Acronym / sponsor ID
- 08-2013-020
- Conditions
- Pressure Ulcer, Wound, Necrosis
- Keywords
- pressure ulcer, chronic wound, tissue necrosis, slough, ultra sound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 11 Dec 2013 (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.
Study objective The purpose of this trial is to evaluate the efficacy and safety of the investigational device, ULSD-12D, as Compared to the comparator, SONOCA-180, in chronic wound.
Detailed description
- Study design Multi-center, randomized clinical trial
- Study population Adults with chronic wound
- Investigational device treatment procedure Before Treatment: The subject's eligibility (inclusion/exclusion criteria) will be assessed,and apply the Study Device or Comparator on their wound in a randomized manner. Post-Treatment: All subjects will take pictures of the wound area and measured the number of microorganism and wound size.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ULSD-12D | Experimental | Device: ULSD-12Dultrasound surgical device made by Ultech. |
| SONOCA-180 | Active comparator | Device: SONOCA-180ultrasound surgical device made by Soering |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- over 20 years of age
- subject who has untreated wounds
- subject who has wound size over 3cm x 3cm
- subject who has wound over stage 2
Key exclusion criteria (1 listed)
- cellulitis
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 |
|---|---|---|
| ULSD-12Dwound cleansing and debridement using ULSD-12D | Device | ULSD-12D |
| SONOCA-180wound cleansing and debridement using SONOCA-180 | Device | SONOCA-180 |
Primary outcome
The number of microorganisms on wound bed
Time frame: Baseline and 30minuts post debridement
Investigator measured the number of microorganisms on wound bed at pre and post debridement using nitrocellulose filter.
1 secondary outcome
necrotic tissue region
Time frame: Baseline and 30minuts post debridement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2014.
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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.
Chanyeong - Heo, Ph.D principal investigator
Seoul National University Bundang Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ULSD-12D and SONOCA-180 in people with Pressure Ulcer and Wound, run by Seoul National University Hospital at 3 sites 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 4 inclusion and 1 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: finished, as of the sponsor's last update on 7 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of microorganisms on wound bed (time frame: Baseline and 30minuts post debridement). 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 7 Apr 2014.