NCT02007824

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 11, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

April 7, 2014

Status Verified

April 1, 2014

Enrollment Period

6 months

First QC Date

October 31, 2013

Last Update Submit

April 4, 2014

Conditions

Pressure UlcerWoundNecrosis

Keywords

pressure ulcerchronic woundtissue necrosissloughultra sound

Outcome Measures

Primary Outcomes (1)

  • The number of microorganisms on wound bed

    Investigator measured the number of microorganisms on wound bed at pre and post debridement using nitrocellulose filter.

    Baseline and 30minuts post debridement

Secondary Outcomes (1)

  • necrotic tissue region

    Baseline and 30minuts post debridement

Study Arms (2)

ULSD-12D

EXPERIMENTAL

ultrasound surgical device made by Ultech.

Device: ULSD-12D

SONOCA-180

ACTIVE COMPARATOR

ultrasound surgical device made by Soering

Device: SONOCA-180

Interventions

ULSD-12DDEVICE

wound cleansing and debridement using ULSD-12D

ULSD-12D
SONOCA-180DEVICE

wound cleansing and debridement using SONOCA-180

SONOCA-180

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • cellulitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Samsung Medical Center

Seoul, Gangnam-gu, 135-710, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

Hanyang University Hospital

Seoul, Seongdong-gu, 133-791, South Korea

Location

MeSH Terms

Conditions

Pressure UlcerWounds and InjuriesNecrosis

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Chanyeong - Heo, Ph.D

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

October 31, 2013

First Posted

December 11, 2013

Study Start

August 1, 2013

Primary Completion

February 1, 2014

Study Completion

March 1, 2014

Last Updated

April 7, 2014

Record last verified: 2014-04

Locations

KR(3)