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| Sponsors and Collaborators: |
Maastricht University KCI medical B.V |
| Information provided by: | Maastricht University |
| ClinicalTrials.gov Identifier: | NCT00243620 |
Purpose
Current treatment modalities for chronic leg ulcers are time consuming, expensive, and only moderately successful. Recent data suggest that creating a sub-atmospheric pressure by Vacuum Assisted Closure (V.A.C.®) therapy supports the wound healing process. Here, we studied the efficacy of V.A.C.® in the treatment of chronic leg ulcers prospectively.
| Condition | Intervention |
|
Leg Ulcer |
Device: Vacuum therapy (device) |
| MedlinePlus related topics: | Leg Injuries and Disorders |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | State-of-the Art Treatment of Chronic Leg Ulcers: a Randomised Controlled Trial Comparing Vacuum Assisted Closure (V.A.C.®) With Modern Wound Dressings |
| Estimated Enrollment: | 60 |
| Study Start Date: | May 2001 |
| Estimated Study Completion Date: | May 2004 |
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Show Detailed Description |
Eligibility
| Ages Eligible for Study: | up to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
patient with a chronic leg ulcer (> 6 months) without healing signs and satisfies to one or more criteria:
Exclusion Criteria:
Contacts and Locations| Netherlands, 6202 AZ | |||||
| Department of dermatology | |||||
| Maastricht, 6202 AZ, Netherlands, 5800 | |||||
| Maastricht University |
| KCI medical B.V |
| Principal Investigator: | Jeroen Vuerstaek, MD | Department of dermatology, UniversityHospital Maastricht |
| Study Chair: | Peter Steijlen, Prof. | Department of dermatology, University Hospital Maastricht |
More Information
| Study ID Numbers: | CB/jd/01.259 |
| First Received: | October 21, 2005 |
| Last Updated: | October 21, 2005 |
| ClinicalTrials.gov Identifier: | NCT00243620 |
| Health Authority: | Netherlands: Independent Ethics Committee |
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