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

Primary Purpose

Chronic Lower Leg Ulcer

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Autologous Platelet Enriched Gel
Metalloproteinase Inhibitor
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Lower Leg Ulcer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Ghent

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Autologous Platelet Enriched Gel

Metalloproteinase Inhibitor (Promogran)

Outcomes

Primary Outcome Measures

Wound healing

Secondary Outcome Measures

Wound healing

Full Information

First Posted
April 7, 2008
Last Updated
January 3, 2023
Sponsor
University Hospital, Ghent
Collaborators
Medtronic, Johnson & Johnson
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1. Study Identification

Unique Protocol Identification Number
NCT00658983
Brief Title
Autologous Platelet Enriched Gel Versus Metalloproteinase Inhibitor in the Healing of Chronic Lower Leg Ulcers
Official Title
Autologous Platelet Enriched Gel Versus Metalloproteinase Inhibitor in the Healing of Chronic Lower Leg Ulcers
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2008 (Actual)
Primary Completion Date
August 20, 2010 (Actual)
Study Completion Date
August 20, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
Collaborators
Medtronic, Johnson & Johnson

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lower Leg Ulcer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Autologous Platelet Enriched Gel
Arm Title
2
Arm Type
Active Comparator
Arm Description
Metalloproteinase Inhibitor (Promogran)
Intervention Type
Other
Intervention Name(s)
Autologous Platelet Enriched Gel
Intervention Description
Treatment with Autologous Platelet Enriched Gel
Intervention Type
Other
Intervention Name(s)
Metalloproteinase Inhibitor
Intervention Description
Treatment with Metalloproteinase Inhibitor (Promogran)
Primary Outcome Measure Information:
Title
Wound healing
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Wound healing
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wim Bongaerts, MD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wouter De Moor
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Links:
URL
http://www.uzgent.be
Description
Related Info

Learn more about this trial

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

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