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

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ClinicalTrials.gov Identifier: NCT00658983
Recruitment Status : Unknown
Verified February 2014 by University Hospital, Ghent.
Recruitment status was:  Recruiting
First Posted : April 16, 2008
Last Update Posted : December 5, 2014
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Compare Autologous Platelet Enriched Gel versus Metalloproteinase Inhibitor in the healing of chronic lower leg ulcers.

Condition or disease Intervention/treatment
Chronic Lower Leg Ulcer Other: Autologous Platelet Enriched Gel Other: Metalloproteinase Inhibitor

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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
Study Start Date : April 2008
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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)


Outcome Measures

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

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

Eligibility Criteria

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 Posted: April 16, 2008    Key Record Dates
Last Update Posted: December 5, 2014
Last Verified: February 2014

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