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Safety Study Providing 12 Months Follow-up From First Exposure to HP802-247 in Subjects With Venous Leg Ulcer

NCT01658618 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 440

Last updated 2014-02-03

No results posted yet for this study

Summary

This observations safety study is intended for subject who participated in the 802-247-09-029 study with the investigational product HP802-247 for venous leg ulcers and received at least one application of HP802-247 or Vehicle (an inactive substance). This study is being done for the following purposes:

1. to identify new adverse events,
2. to examine ongoing adverse events not resolved in subjects who participated in the 802-247-09-029 trial,
3. to record wound status, and
4. to determine if there are differences in Health Related Quality of Life (HRQoL) associated with the treatment assignment from the 802-247-09-029 Trial.

Investigational means that HP802-247 has not been approved by the U.S. Food and Drug Administration (FDA).

Conditions

  • Venous Leg Ulcer

Interventions

BIOLOGICAL

HP802-247

Sponsors & Collaborators

  • 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

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2015-03-31
Completion
2015-05-31

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 NCT01658618 on ClinicalTrials.gov