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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01237392 |
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Date of registration:
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08/11/2010 |
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Primary sponsor: |
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Public title:
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Ultrasonic Wound Debridement vs. Standard Sharp Debridement
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Scientific title:
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Ultrasonic Surgical Wound Debridement vs. Standard Sharp Debridement In the Treatment of Chronic Wounds: A Single Center, Randomized, Parallel, Clinical Outcome Trial |
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Date of first enrolment:
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June 2008 |
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Target sample size:
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75 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01237392 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
90 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Chronic Skin Ulcers
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Intervention(s)
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Device: Sonic One ultrasonic debridement device
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Primary Outcome(s)
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Time to complete wound closure
[Time Frame: 12 and 24 weeks]
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Secondary Outcome(s)
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Relative rate of wound healing
[Time Frame: 8, 12 and 24 weeks]
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Secondary ID(s)
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NYSDH-Dbr-06-08
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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