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Observational Study Providing 12 Months of Safety Follow-Up From First Exposure to HP802-247

NCT01970657 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 221

Last updated 2017-06-22

No results posted yet for this study

Summary

This observational safety follow-up study enrolled subjects from the 802-247-09-032 study with the investigational product HP802-247 for venous leg ulcers, who received at least one application of HP802-247 or Vehicle (Placebo). 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 802-247-09-032 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 802-247-09-032 Trial.

About 440 subjects were to participate depending upon subject enrollment from the previous study, 802-247-09-032. The study was conducted in approximately 50 sites in Europe.

Conditions

  • Venous Leg Ulcer (VLU)

Interventions

BIOLOGICAL

No treatment specified

No intervention

BIOLOGICAL

No treatment

None specified

Sponsors & Collaborators

  • Healthpoint

    lead INDUSTRY

Principal Investigators

  • Wolfgang Vanscheidt, MD · University Freiburg-Practice for Dermatology

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2015-11-30
Completion
2015-11-30
FDA Drug
Yes

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 NCT01970657 on ClinicalTrials.gov