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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University Hospital, Ghent
Sponsor:
Collaborators:
Medtronic
Johnson & Johnson
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00658983
First received: April 7, 2008
Last updated: February 1, 2013
Last verified: February 2013
  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
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 2013
Estimated Primary Completion Date: May 2013 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00658983     History of Changes
Other Study ID Numbers: 2008/049
Study First Received: April 7, 2008
Last Updated: February 1, 2013
Health Authority: Belgium: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 16, 2014