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Dose Finding Study of HP802-247 in Venous Leg Ulcers

NCT00852995 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 228

Last updated 2016-10-24

Study results available
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Summary

This is a 16-week study for subjects with a venous leg ulcer between the knee and ankle. This research is being done to determine the effectiveness of two dosing frequencies and two different concentrations of HP802-247, together with standard care, compared to placebo, plus standard care.

Conditions

  • Venous Leg Ulcer
  • Venous Stasis Ulcers

Interventions

BIOLOGICAL

HP802-247

One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.

BIOLOGICAL

Placebo (Vehicle)

Placebo (Vehicle) consisting of: Component 1 - acellular fibrinogen solution; Component 2 - acellular thrombin solution

Sponsors & Collaborators

  • Healthpoint

    lead INDUSTRY

Principal Investigators

  • Herbert B Slade, MD · Healthpoint

  • William Marston, MD · University of North Carolina

  • Robert Kirsner, MD · University of Miami

  • Robert J Snyder, MD · Robert J Snyder

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2011-04-30
Completion
2011-07-31

Countries

  • United States
  • Canada

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 NCT00852995 on ClinicalTrials.gov