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A Randomised Controlled Trial Comparing Vacuum Assisted Closure (V.A.C.®) With Modern Wound Dressings

This study has been completed.
Sponsor:
Collaborator:
Kinetic Concepts, Inc.
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00243620
First received: October 21, 2005
Last updated: NA
Last verified: May 2001
History: No changes posted
  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)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Time-to-complete-healing: i.e. the period between initial preparation of the wound and 100% epithelialisation with the primary endpoint being time-to-complete-healing.

Secondary Outcome Measures:
  • 1)duration of the wound-bed preparation stage
  • 2)percentage of leg ulcer recurrences within one year (i.e. an epithelial breakdown anywhere along or within the index ulcer region)
  • 3)skin-graft survival, where applicable (i.e. percentage of successfully adhered skin grafts after 4 days of complete bed rest and compression or VAC® treatment)
  • 4) the quality of life
  • 5) pain scores
  • 6) the total time needed for wound care until complete wound closure
  • 7) the costs per ulcer.

Estimated Enrollment: 60
Study Start Date: May 2001
Estimated Study Completion Date: May 2004
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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 Criteria:

  1. ulcer duration shorter than 6 months
  2. age > 85 years
  3. use of immune suppressive medication
  4. known type IV allergies against ingredients of the wound care products
  5. insulin-dependent diabetes mellitus type I
  6. severe peripheral arterial disease (ankle/brachial index <0·60)
  7. vasculitic ulcers
  8. neoplastic ulcers.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00243620

Locations
Netherlands
Department of dermatology
Maastricht, 6202 Az, Netherlands, 5800
Sponsors and Collaborators
Maastricht University Medical Center
Kinetic Concepts, Inc.
Investigators
Principal Investigator: Jeroen Vuerstaek, MD Department of dermatology, UniversityHospital Maastricht
Study Chair: Peter Steijlen, Prof. Department of dermatology, University Hospital Maastricht
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00243620     History of Changes
Other Study ID Numbers: CB/jd/01.259
Study First Received: October 21, 2005
Last Updated: October 21, 2005
Health Authority: Netherlands: Independent Ethics Committee

Keywords provided by Maastricht University Medical Center:
Chronic leg ulcers; wound healing; wound care; Vacuum Assisted Closure; topical negative Pressure

Additional relevant MeSH terms:
Leg Ulcer
Ulcer
Skin Ulcer
Skin Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2013