Safety Follow-Up to HP 802-247-09-015

Healthpoint

Status: Completed

Conditions: Venous Leg Ulcer; Venous Stasis Ulcer

Treatments: Biological: No HP802 Treatment; Other: No HP802 Vehicle Treatment

Study type: Observational

Funder types: Industry

Identifiers

NCT00900029

802-247-09-016

Details and patient eligibility

About

This is a 24-week observational follow safety study for Study 802-247-09-015.

Full description

The objective of this study is to examine the durability of previous target wound closures, identify new test article-related adverse events, record new target wound closures, and examine ongoing adverse events not resolved in subjects who participated in HP 802-247-09-015.

Enrollment: 206 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

INCLUSION CRITERIA:

• Provide informed consent
• Willing to comply with protocol instructions, including allowing all study assessments.
• Subject was randomized in HP 802-247-09-015 and received at least one application of a test article, whether active or placebo.
• Subject has ended their participation in HP 802-247-09-015 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.

Trial design

206 participants in 2 patient groups

No HP802 Treatment

Description:

Treatment received in Study 802-247-09-015 was HP802

Treatment:

Biological: No HP802 Treatment

No HP802 Vehicle Treatment

Description:

Treatment received in Study 802-247-09-015 was HP802 Vehicle

Treatment:

Other: No HP802 Vehicle Treatment