NCT00658983

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 16, 2008

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2010

Completed
Last Updated

January 5, 2023

Status Verified

January 1, 2023

Enrollment Period

2.4 years

First QC Date

April 7, 2008

Last Update Submit

January 3, 2023

Conditions

Chronic Lower Leg Ulcer

Outcome Measures

Primary Outcomes (1)

  • Wound healing

    6 weeks

Secondary Outcomes (1)

  • Wound healing

    6 months

Study Arms (2)

1

EXPERIMENTAL

Autologous Platelet Enriched Gel

Other: Autologous Platelet Enriched Gel

2

ACTIVE COMPARATOR

Metalloproteinase Inhibitor (Promogran)

Other: Metalloproteinase Inhibitor

Interventions

Autologous Platelet Enriched GelOTHER

Treatment with Autologous Platelet Enriched Gel

1
Metalloproteinase InhibitorOTHER

Treatment with Metalloproteinase Inhibitor (Promogran)

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • year or older
  • A non-healing chronic lower leg ulcer
  • Platelet ranges of 150000 per ml circulating blood

You may not qualify if:

  • Presence of a tumor or metastatic disease
  • Hypersensitive to collagen regenerated cellulose
  • Hemodynamic unstable patient
  • Hypercoagulability
  • Heart decompensation or angina pectoris

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Links

Study Officials

  • Wim Bongaerts, MD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

  • Wouter De Moor

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2008

First Posted

April 16, 2008

Study Start

April 1, 2008

Primary Completion

August 20, 2010

Study Completion

August 20, 2010

Last Updated

January 5, 2023

Record last verified: 2023-01

Locations

BE(1)