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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:
Medtronic
Johnson & Johnson
Information provided by (Responsible Party):
University Hospital, Ghent

Tracking Information
First Submitted Date  ICMJE April 7, 2008
First Posted Date  ICMJE April 16, 2008
Last Update Posted Date December 5, 2014
Study Start Date  ICMJE April 2008
Estimated Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 14, 2008)
Wound healing [ Time Frame: 6 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00658983 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2008)
Wound healing [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Autologous Platelet Enriched Gel Versus Metalloproteinase Inhibitor in the Healing of Chronic Lower Leg Ulcers
Official Title  ICMJE Autologous Platelet Enriched Gel Versus Metalloproteinase Inhibitor in the Healing of Chronic Lower Leg Ulcers
Brief Summary Compare Autologous Platelet Enriched Gel versus Metalloproteinase Inhibitor in the healing of chronic lower leg ulcers.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Lower Leg Ulcer
Intervention  ICMJE
  • Other: Autologous Platelet Enriched Gel
    Treatment with Autologous Platelet Enriched Gel
  • Other: Metalloproteinase Inhibitor
    Treatment with Metalloproteinase Inhibitor (Promogran)
Study Arms  ICMJE
  • Experimental: 1
    Autologous Platelet Enriched Gel
    Intervention: Other: Autologous Platelet Enriched Gel
  • Active Comparator: 2
    Metalloproteinase Inhibitor (Promogran)
    Intervention: Other: Metalloproteinase Inhibitor
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 14, 2008)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2015
Estimated Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00658983
Other Study ID Numbers  ICMJE 2008/049
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Ghent
Study Sponsor  ICMJE University Hospital, Ghent
Collaborators  ICMJE
  • Medtronic
  • Johnson & Johnson
Investigators  ICMJE
Principal Investigator: Wim Bongaerts, MD University Hospital, Ghent
Principal Investigator: Wouter De Moor University Hospital, Ghent
PRS Account University Hospital, Ghent
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP