NCT01237392

Brief Summary

A single center, randomized, parallel, clinical outcome trial to compare the rate of healing in chronic wounds debrided with either high energy ultrasonic debridement (with cavitation) or standard of care sharp debridement.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

June 1, 2008

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

November 8, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 9, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

July 24, 2014

Status Verified

July 1, 2014

Enrollment Period

2.8 years

First QC Date

November 8, 2010

Last Update Submit

July 22, 2014

Conditions

Chronic Skin Ulcers

Keywords

wound debridementrequiring debridement

Outcome Measures

Primary Outcomes (1)

  • Time to complete wound closure

    12 and 24 weeks

Secondary Outcomes (1)

  • Relative rate of wound healing

    8, 12 and 24 weeks

Study Arms (2)

Contact Ultrasonic Debridement Device

ACTIVE COMPARATOR
Device: Contact ultrasonic debridement device

Standard Sharp Debridement

ACTIVE COMPARATOR
Device: Contact ultrasonic debridement device

Interventions

Contact ultrasonic debridement deviceDEVICE

Cavitational ultrasound wound debridement device

Also known as: SonicOne, Misonix Inc, Farmingdale NY
Contact Ultrasonic Debridement DeviceStandard Sharp Debridement

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic wound needing debridement \>3 cm2
  • Ulcer history \>4mo
  • Adequate arterial blood flow (ABI\>0.7)
  • Venous, Inflammatory, Pressure, Diabetic

You may not qualify if:

  • Bleeding disorder
  • ABI\<0.7
  • Uncontrolled diabetes
  • Taking systemic corticosteroids
  • Chemotherapy
  • Participating in another study
  • Treatment with Apligraft, Dermagraft, or Regranex within 90 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Calvary Hospital Center for Curative and Palliative Wound Care

The Bronx, New York, 10461, United States

Location

Study Officials

  • Oscar M Alvarez, PhD

    Director, Wound care Center, Calvary Hospital

    PRINCIPAL INVESTIGATOR

  • Martin E Wendelken, DPM, RN

    Physician, Wound Care Center, Calvary Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Center for Curative and Palliative Wound Care

Study Record Dates

First Submitted

November 8, 2010

First Posted

November 9, 2010

Study Start

June 1, 2008

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

July 24, 2014

Record last verified: 2014-07

Locations

US(1)