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

Status unconfirmed

Conditions studied: Venous Leg Ulcer

In brief

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).

Key facts

Study ID

NCT01658618

Run by

Healthpoint

People needed

440

Starts

2012-09-01

Expected to finish

2015-05-01

Last updated by the study team

2014-02-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Provide informed consent document
• Subject was randomized in 802-247-09-029 and received at least one application of a test article.
• Subject has ended their participation in 802-247-09-029 by virtue of completing the study, or by dropping out prior to completion.

You may not qualify if…

• Subjects who refuse to provide written informed consent will be excluded from this trial.

Where it is running

• Study site — Glendale, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Carlsbad, California, United States
• Study site — Castro Valley, California, United States
• Study site — Laguna Hills, California, United States
• Study site — Long Beach, California, United States
• Study site — Los Angeles, California, United States
• Study site — San Diego, California, United States
• Study site — San Francisco, California, United States
• Study site — Stockton, California, United States
• Study site — Sylmar, California, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Gainesville, Florida, United States
• Study site — Hialeah, Florida, United States
• Study site — Miami, Florida, United States
• Study site — South Miami, Florida, United States
• Study site — Tamarac, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Chicago, Illinois, United States
• Study site — Chicago, Illinois, United States
• Study site — Jacksonville, Illinois, United States
• Study site — North Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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