Status:

COMPLETED

Ultrasonic Wound Debridement vs. Standard Sharp Debridement

Lead Sponsor:

Calvary Hospital, Bronx, NY

Conditions:

Chronic Skin Ulcers

Eligibility:

All Genders

18-90 years

Phase:

NA

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 ...

Eligibility Criteria

Inclusion

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

Exclusion

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

Key Trial Info

Start Date :

June 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 1 2011

Estimated Enrollment :

75 Patients enrolled

Trial Details

Trial ID

NCT01237392

Start Date

June 1 2008

End Date

April 1 2011

Last Update

July 24 2014

Active Locations (1)

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Calvary Hospital Center for Curative and Palliative Wound Care

The Bronx, New York, United States, 10461