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Clinical Trial to Evaluate Ultrasonic Surgical Device in Chronic Pressure Ulcer

Seoul National University logo

Seoul National University

Status

Completed

Conditions

Wound
Pressure Ulcer
Necrosis

Treatments

Device: SONOCA-180
Device: ULSD-12D

Study type

Interventional

Funder types

Other

Identifiers

NCT02007824
08-2013-020
ULSC-12D (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • cellulitis

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

30 participants in 2 patient groups

ULSD-12D
Experimental group
Description:
ultrasound surgical device made by Ultech.
Treatment:
Device: ULSD-12D
SONOCA-180
Active Comparator group
Description:
ultrasound surgical device made by Soering
Treatment:
Device: SONOCA-180

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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