Chronic Skin UlcersNCT01237392
Ultrasonic Wound Debridement vs. Standard Sharp Debridement
A study testing Contact ultrasonic debridement device in people with Chronic Skin Ulcers, run by Calvary Hospital, Bronx, NY at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chronic Skin Ulcers
- What is being tested?
- Contact ultrasonic debridement device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Apr 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic wound needing debridement >3 cm2
- Ulcer history >4mo
- Adequate arterial blood flow (ABI>0.7)
- Venous, Inflammatory, Pressure, Diabetic
Who cannot join
- Bleeding disorder
- ABI<0.7
- Uncontrolled diabetes
- Taking systemic corticosteroids
- Chemotherapy
- Participating in another study
- Treatment with Apligraft, Dermagraft, or Regranex within 90 days
Trial locations and contacts
1 site in 1 country.
United States1 site
Calvary Hospital Center for Curative and Palliative Wound Care
The Bronx, New York, 10461
About this study
Official title: Ultrasonic Surgical Wound Debridement vs. Standard Sharp Debridement In the Treatment of Chronic Wounds: A Single Center, Randomized, Parallel, Clinical Outcome Trial
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.
- Conditions
- Chronic Skin Ulcers
- Being tested
- Contact ultrasonic debridement device
- Keywords
- wound debridement, requiring debridement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contact ultrasonic debridement deviceDevice
Also called SonicOne, Misonix Inc, Farmingdale NY
Cavitational ultrasound wound debridement device
| Study group | Role | What they receive |
|---|---|---|
| Contact Ultrasonic Debridement Device | Active comparator | Not described Receives: Device: Contact ultrasonic debridement device |
| Standard Sharp Debridement | Active comparator | Not described Receives: Device: Contact ultrasonic debridement device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to complete wound closure
Measured: 12 and 24 weeks
Secondary outcomes (1)
Relative rate of wound healing
Measured: 8, 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2010 (estimated)
- Study startJun 2008
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Skin UlcersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Calvary Hospital, Bronx, NY
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oscar M. Alvarez, PhD, Calvary Hospital, Bronx, NY
- Investigators
- Oscar M Alvarez, PhD, Principal investigator, Director, Wound care Center, Calvary HospitalMartin E Wendelken, DPM, RN, Study director, Physician, Wound Care Center, Calvary Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01237392
- Sponsor's protocol ID
- NYSDH-Dbr-06-08
- Status last verified
- Jul 2014
- First submitted
- 8 Nov 2010
- Last updated
- 24 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonic Surgical Wound Debridement vs. Standard Sharp Debridement In the Treatment of Chronic Wounds: A Single Center, Randomized, Parallel, Clinical Outcome Trial
- ClinicalTrials.gov ID
- NCT01237392
- Acronym / sponsor ID
- NYSDH-Dbr-06-08
- Conditions
- Chronic Skin Ulcers
- Keywords
- wound debridement, requiring debridement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Calvary Hospital, Bronx, NYUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 9 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Contact Ultrasonic Debridement Device | Active comparator | Device: Contact ultrasonic debridement device |
| Standard Sharp Debridement | Active comparator | Device: Contact ultrasonic debridement device |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Chronic wound needing debridement >3 cm2
- Ulcer history >4mo
- Adequate arterial blood flow (ABI>0.7)
- Venous, Inflammatory, Pressure, Diabetic
Key exclusion criteria (7 listed)
- Bleeding disorder
- ABI<0.7
- Uncontrolled diabetes
- Taking systemic corticosteroids
- Chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contact ultrasonic debridement deviceAlso: SonicOne, Misonix Inc, Farmingdale NYCavitational ultrasound wound debridement device | Device | Contact Ultrasonic Debridement Device, Standard Sharp Debridement |
Primary outcome
Time to complete wound closure
Time frame: 12 and 24 weeks
1 secondary outcome
Relative rate of wound healing
Time frame: 8, 12 and 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2014.
Related trials for Chronic Skin Ulcers
Recruiting
Vacuum Compression Therapy and Tissue Oxygenation in Chronic Leg Ulcers
Leg Ulcers, Leg Ulcers Venous
RecruitingPhase 4
Topical Sevoflurane for Treatment of Chronic Leg Ulcers
Leg Ulcer
RecruitingPhase 2
Evaluation of the Safety and Efficacy of Live ASCs in the Treatment of Diabetic Foot Syndrome.
Diabetic Foot Ulcer
RecruitingObservational study
Factors Associated With an Evolution in the Quality of Life of Diabetic Patients With Chronic, Wound-free Charcot Foot
Charcot Joint of Foot, Osteoarthropathy
Not yet recruiting
Subcutaneous Dexpanthenol Administration and Wound Epithelialization
Chronic Wounds, Diabetic Foot Ulcer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oscar M Alvarez, PhD principal investigator
Director, Wound care Center, Calvary Hospital
Martin E Wendelken, DPM, RN study director
Physician, Wound Care Center, Calvary Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contact ultrasonic debridement device in people with Chronic Skin Ulcers, run by Calvary Hospital, Bronx, NY at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to complete wound closure (time frame: 12 and 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2014.