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

This study has been completed.
Sponsor:
Collaborator:
KCI medical B.V
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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
KCI medical B.V
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:
Ulcer
Leg Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases

ClinicalTrials.gov processed this record on September 30, 2014