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

Venous Leg Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01658618
• Other study ID #: 802-247-09-030
• Status: Unknown status
• Phase: N/A
• First received: August 1, 2012
• Last updated: January 31, 2014
• Start date: September 2012
• Est. completion date: May 2015

Study information

• Verified date: January 2014
• Source: Healthpoint
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 440
• Est. completion date: May 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Leg Ulcer
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcer

Intervention

Biological:
• HP802-247

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Healthpoint

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Objective	The objectives of this study are to identify new adverse events, examine ongoing adverse events not resolved in subjects who participated in the 802-247-09-029 trial, and record wound status.	12 months
Secondary	Exploratory Objectives	The Health Economic objective for this study is 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.	12 Months