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Autologous Platelet Enriched Gel Versus Metalloproteinase Inhibitor in the Healing of Chronic Lower Leg Ulcers

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2014 by University Hospital, Ghent.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00658983
First Posted: April 16, 2008
Last Update Posted: December 5, 2014
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.
Collaborators:
Medtronic
Johnson & Johnson
Information provided by (Responsible Party):
University Hospital, Ghent
  Purpose
Compare Autologous Platelet Enriched Gel versus Metalloproteinase Inhibitor in the healing of chronic lower leg ulcers.

Condition Intervention
Chronic Lower Leg Ulcer Other: Autologous Platelet Enriched Gel Other: Metalloproteinase Inhibitor

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Autologous Platelet Enriched Gel Versus Metalloproteinase Inhibitor in the Healing of Chronic Lower Leg Ulcers

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Wound healing [ Time Frame: 6 weeks ]

Secondary Outcome Measures:
  • Wound healing [ Time Frame: 6 months ]

Estimated Enrollment: 20
Study Start Date: April 2008
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Autologous Platelet Enriched Gel
Other: Autologous Platelet Enriched Gel
Treatment with Autologous Platelet Enriched Gel
Active Comparator: 2
Metalloproteinase Inhibitor (Promogran)
Other: Metalloproteinase Inhibitor
Treatment with Metalloproteinase Inhibitor (Promogran)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 year or older
  • A non-healing chronic lower leg ulcer
  • Platelet ranges of 150000 per ml circulating blood

Exclusion Criteria:

  • Presence of a tumor or metastatic disease
  • Hypersensitive to collagen regenerated cellulose
  • Hemodynamic unstable patient
  • Hypercoagulability
  • Heart decompensation or angina pectoris
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00658983


Contacts
Contact: Wim Bongaerts, MD +32 9 332 67 95 Willem.bongaerts@ugent.be

Locations
Belgium
University Hospital Ghent Recruiting
Ghent, Belgium, 9000
Contact: Wouter De Moor       Wouter.demoor@uzgent.be   
Sponsors and Collaborators
University Hospital, Ghent
Medtronic
Johnson & Johnson
Investigators
Principal Investigator: Wim Bongaerts, MD University Hospital, Ghent
Principal Investigator: Wouter De Moor University Hospital, Ghent
  More Information

Additional Information:
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00658983     History of Changes
Other Study ID Numbers: 2008/049
First Submitted: April 7, 2008
First Posted: April 16, 2008
Last Update Posted: December 5, 2014
Last Verified: February 2014

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