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

NCT01853384 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 252

Last updated 2016-10-03

Study results available
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Summary

This study is being done to find out if an investigational product called HP802-247 can help people with venous leg ulcers. Investigational means that HP802-247 has not been approved by the U.S. Food and Drug Administration (FDA).

This research is being done to compare the efficacy of HP802-247 plus compression therapy against Vehicle plus compression therapy in achieving complete wound closure over the 12-week treatment period. Vehicle looks the same as HP802-247 but contains no cells.

At least 440 subjects will participate. The study is going to be conducted in approximately 5 countries at approximately 50 sites across the European Union.

Conditions

  • Venous Ulcer
  • Venous Stasis Ulcer
  • Ulcer

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.

Sponsors & Collaborators

  • Healthpoint

    lead INDUSTRY

Principal Investigators

  • Herbert B. Slade, MD · Smith & Nephew, Inc.

  • Tommy Lee, MSHS · Smith & Nephew, Inc.

  • Wolfgang Vanscheidt, Professor Dr · University Freiburg-Practice for Dermatology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2014-12-31
Completion
2015-02-28

Countries

  • Belgium
  • Czechia
  • Germany
  • Hungary
  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01853384 on ClinicalTrials.gov