Ultrasonic Wound Debridement vs. Standard Sharp Debridement

NCT ID: NCT01237392

Last Updated: 2014-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2011-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Skin Ulcers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Contact Ultrasonic Debridement Device

Group Type ACTIVE_COMPARATOR

Contact ultrasonic debridement device

Intervention Type DEVICE

Cavitational ultrasound wound debridement device

Standard Sharp Debridement

Group Type ACTIVE_COMPARATOR

Contact ultrasonic debridement device

Intervention Type DEVICE

Cavitational ultrasound wound debridement device

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Contact ultrasonic debridement device

Cavitational ultrasound wound debridement device

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

SonicOne, Misonix Inc, Farmingdale NY

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Calvary Hospital, Bronx, NY

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Oscar M. Alvarez, PhD

Director, Center for Curative and Palliative Wound Care

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Oscar M Alvarez, PhD

Role: PRINCIPAL_INVESTIGATOR

Director, Wound care Center, Calvary Hospital

Martin E Wendelken, DPM, RN

Role: STUDY_DIRECTOR

Physician, Wound Care Center, Calvary Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Calvary Hospital Center for Curative and Palliative Wound Care

The Bronx, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NYSDH-Dbr-06-08

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Treatment of Diabetic Foot Ulcers With AUP1602-C
NCT04281992 COMPLETED PHASE1/PHASE2