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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00243620
Recruitment Status : Completed
First Posted : October 24, 2005
Last Update Posted : January 13, 2017
KCI medical B.V
Information provided by:
Maastricht University Medical Center

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 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 or disease Intervention/treatment Phase
Leg Ulcer Device: Vacuum therapy (device) Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : May 2001
Study Completion Date : May 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. 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. 1)duration of the wound-bed preparation stage
  2. 2)percentage of leg ulcer recurrences within one year (i.e. an epithelial breakdown anywhere along or within the index ulcer region)
  3. 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. 4) the quality of life
  5. 5) pain scores
  6. 6) the total time needed for wound care until complete wound closure
  7. 7) the costs per ulcer.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   up to 85 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00243620

Nederland, Zuid-Limburg, Netherlands, 6229 HX
Sponsors and Collaborators
Maastricht University Medical Center
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 Identifier: NCT00243620     History of Changes
Other Study ID Numbers: CB/jd/01.259
First Posted: October 24, 2005    Key Record Dates
Last Update Posted: January 13, 2017
Last Verified: May 2001

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
Pathologic Processes
Skin Ulcer
Skin Diseases