Status:
COMPLETED
A Randomised Controlled Trial Comparing Vacuum Assisted Closure (V.A.C.®) With Modern Wound Dressings
Lead Sponsor:
Maastricht University Medical Center
Collaborating Sponsors:
KCI medical B.V
Conditions:
Leg Ulcer
Eligibility:
All Genders
Up to 85 years
Phase:
NA
Brief Summary
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 Closu...
Detailed Description
PROTOCOL I. INTRODUCTION: In the last 25 years we have entered an area where patients are living longer with more complex systemic pathology. The number of patients with chronic non-healing wounds c...
Eligibility Criteria
Inclusion
- patient with a chronic leg ulcer (\> 6 months) without healing signs and satisfies to one or more criteria:
- Venous (venous insufficiency of the deep or superficial system without an arterial incompetence)
- Combined venous/arterial (venous insufficiency of the deep or superficial system with an ankle/brachial index of 0·60 - 0·85)
- Arteriolosclerotic (Martorell's ulcer) leg ulcers (diagnose made by anamnesis, clinical signs, exclusions of differential diagnosis's, venous/ arterial duplex shows no signs of obstruction or major venous insufficiency, histology)
Exclusion
- ulcer duration shorter than 6 months
- age \> 85 years
- use of immune suppressive medication
- known type IV allergies against ingredients of the wound care products
- insulin-dependent diabetes mellitus type I
- severe peripheral arterial disease (ankle/brachial index \<0·60)
- vasculitic ulcers
- neoplastic ulcers.
Key Trial Info
Start Date :
May 1 2001
Trial Type :
INTERVENTIONAL
End Date :
May 1 2004
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00243620
Start Date
May 1 2001
End Date
May 1 2004
Last Update
January 13 2017
Active Locations (1)
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1
MUMC
Nederland, Zuid-Limburg, Netherlands, 6229 HX