NCT00243620

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2001

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2001

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

October 21, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 24, 2005

Completed
Last Updated

January 13, 2017

Status Verified

May 1, 2001

First QC Date

October 21, 2005

Last Update Submit

January 12, 2017

Conditions

Leg Ulcer

Keywords

Chronic leg ulcers; wound healing; wound care; Vacuum Assisted Closure; topical negative Pressure

Outcome Measures

Primary Outcomes (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 Outcomes (7)

  • 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

  • +2 more secondary outcomes

Interventions

Vacuum therapy (device)DEVICE

Eligibility Criteria

AgeUp to 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MUMC

Nederland, Zuid-Limburg, 6229 HX, Netherlands

Location

MeSH Terms

Conditions

Leg Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Jeroen Vuerstaek, MD

    Department of dermatology, UniversityHospital Maastricht

    PRINCIPAL INVESTIGATOR

  • Peter Steijlen, Prof.

    Department of dermatology, University Hospital Maastricht

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 21, 2005

First Posted

October 24, 2005

Study Start

May 1, 2001

Study Completion

May 1, 2004

Last Updated

January 13, 2017

Record last verified: 2001-05

Locations

NL(1)