Autologous Platelet Enriched Gel Versus Metalloproteinase... | NCT00658983

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

NCT00658983

Sponsor

University Hospital, Ghent

Status

Completed

Last Update Posted

Jan 5, 2023Actual

Enrollment

18Actual

Phase

Not Applicable

Conditions

Chronic Lower Leg Ulcer

Interventions

Autologous Platelet Enriched Gel
Metalloproteinase Inhibitor

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2008Actual

Primary Completion Date

Aug 20, 2010Actual

Completion Date

Aug 20, 2010Actual

First Submitted Date

Apr 7, 2008

First Submission Date that Met QC Criteria

Apr 14, 2008

First Posted Date

Apr 16, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 3, 2023

Last Update Posted Date

Jan 5, 2023Actual

Name	Class
Medtronic	INDUSTRY
Johnson & Johnson	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Autologous Platelet Enriched Gel	Other: Autologous Platelet Enriched Gel
2	Active Comparator	Metalloproteinase Inhibitor (Promogran)	Other: Metalloproteinase Inhibitor

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Autologous Platelet Enriched Gel	Other	Treatment with Autologous Platelet Enriched Gel	1

Measure	Description	Time Frame
Wound healing		6 weeks

Measure	Description	Time Frame
Wound healing		6 months

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wim Bongaerts, MD	University Hospital, Ghent	Principal Investigator
Wouter De Moor	University Hospital, Ghent	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Ghent		Ghent		9000	Belgium