Chronic Skin Ulcers Clinical Trial
Official title:
Ultrasonic Surgical Wound Debridement vs. Standard Sharp Debridement In the Treatment of Chronic Wounds: A Single Center, Randomized, Parallel, Clinical Outcome Trial
| Verified date | July 2014 |
| Source | Calvary Hospital, Bronx, NY |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 75 |
| Est. completion date | April 2011 |
| Est. primary completion date | April 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 90 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
| Country | Name | City | State |
|---|---|---|---|
| United States | Calvary Hospital Center for Curative and Palliative Wound Care | Bronx | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Calvary Hospital, Bronx, NY |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time to complete wound closure | 12 and 24 weeks | No | |
| Secondary | Relative rate of wound healing | 8, 12 and 24 weeks | No |