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

This study has been completed.

First Received: October 21, 2005 No Changes Posted

Sponsor:	Maastricht University Medical Center
Collaborator:	Kinetic Concepts, Inc.
Information provided by:	Maastricht University Medical Center
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)

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

Resource links provided by NLM:

MedlinePlus related topics: Leg Injuries and Disorders

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:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00243620

Locations

Netherlands, 6202 AZ
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

Study ID Numbers:	CB/jd/01.259
Study First Received:	October 21, 2005
Last Updated:	October 21, 2005
ClinicalTrials.gov Identifier:	NCT00243620 History of Changes
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:

Pathologic Processes
Skin Diseases
Ulcer
Skin Ulcer
Leg Ulcer

ClinicalTrials.gov processed this record on February 04, 2010