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

NCT ID: NCT00658983

Last Updated: 2023-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-01

Study Completion Date

2010-08-20

Brief Summary

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

Detailed Description

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Conditions

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Chronic Lower Leg Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Autologous Platelet Enriched Gel

Group Type EXPERIMENTAL

Autologous Platelet Enriched Gel

Intervention Type OTHER

Treatment with Autologous Platelet Enriched Gel

2

Metalloproteinase Inhibitor (Promogran)

Group Type ACTIVE_COMPARATOR

Metalloproteinase Inhibitor

Intervention Type OTHER

Treatment with Metalloproteinase Inhibitor (Promogran)

Interventions

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Autologous Platelet Enriched Gel

Treatment with Autologous Platelet Enriched Gel

Intervention Type OTHER

Metalloproteinase Inhibitor

Treatment with Metalloproteinase Inhibitor (Promogran)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic

INDUSTRY

Sponsor Role collaborator

Johnson & Johnson

INDUSTRY

Sponsor Role collaborator

University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wim Bongaerts, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Wouter De Moor

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

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University Hospital Ghent

Ghent, , Belgium

Site Status

Countries

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Belgium

Related Links

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Other Identifiers

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2008/049

Identifier Type: -

Identifier Source: org_study_id

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