Safety and Efficacy Trial of HP802-247 in the Treatment of Chronic Venous Leg Ulcers

PHASE3TerminatedINTERVENTIONAL
Enrollment

252

Participants

Timeline

Start Date

November 30, 2013

Primary Completion Date

December 31, 2014

Study Completion Date

February 28, 2015

Conditions
Venous UlcerVenous Stasis UlcerUlcer
Interventions
BIOLOGICAL

HP802-247

Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days.

OTHER

HP802-247 Vehicle

HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface.

Trial Locations (46)

Unknown

Anderlecht

Brussels

Edegen

Ghent

Kortrijk

Brno

Hradec Králové

Olomouc

Pardubice

Plzen-Bory

Prague

Třebíč

Uherské Hradiště

Ústí nad Labem

Bochum

Bonn

Cologne

Dresden

Düsseldorf

Essen

Freiburg im Breisgau

Göttingen

Greifswald

Hamburg

Kiel

Krefeld

Magdeburg

München

Münster

Budapest

Debrecen

Hatvan

Orosháza

Sátoraljaújhely

Szeged

Szolnok

Katowice

Krakow

Lodz

Lublin

Poznan

Rzeszów

Studzionka

Warsaw

Wroclaw

Zabrze

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Healthpoint

INDUSTRY