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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2014 by University Hospital, Ghent.
Recruitment status was  Recruiting
Johnson & Johnson
Information provided by (Responsible Party):
University Hospital, Ghent Identifier:
First received: April 7, 2008
Last updated: December 4, 2014
Last verified: February 2014
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Wound healing [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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)


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00658983

Contact: Wim Bongaerts, MD +32 9 332 67 95

University Hospital Ghent Recruiting
Ghent, Belgium, 9000
Contact: Wouter De Moor   
Sponsors and Collaborators
University Hospital, Ghent
Johnson & Johnson
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 Identifier: NCT00658983     History of Changes
Other Study ID Numbers: 2008/049 
Study First Received: April 7, 2008
Last Updated: December 4, 2014
Health Authority: Belgium: Institutional Review Board

Additional relevant MeSH terms:
Leg Ulcer
Pathologic Processes
Skin Diseases
Skin Ulcer processed this record on May 26, 2016