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Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers

NCT01656889 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 447

Last updated 2016-03-14

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.

Conditions

  • Venous Leg Ulcers

Interventions

BIOLOGICAL

HP-802-247

HP802-247 (fibrinogen solution \& thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days.

BIOLOGICAL

Vehicle

(fibrinogen solution \& thrombin solution without cells)

Sponsors & Collaborators

  • Smith & Nephew, Inc.

    collaborator INDUSTRY

  • Healthpoint

    lead INDUSTRY

Principal Investigators

  • Herbert B Slade, MD · Chief Medical Officer

  • Tommy Lee, MSHS · Associate Director Clinical Operations

  • Robert Kirsner, MD · Investigator

  • William Marston, MD · Investigator

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2014-12-31
Completion
2014-12-31

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 NCT01656889 on ClinicalTrials.gov