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

Venous Leg Ulcer Clinical Trial

Official title:

A Twenty-Four Week Non-Interventional Safety Follow-Up to HP 802-247-09-015

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00900029
• Other study ID #: 802-247-09-016
• Status: Completed
• Phase: N/A
• First received: May 11, 2009
• Last updated: September 28, 2016
• Start date: June 2009
• Est. completion date: January 2012

Study information

• Verified date: September 2016
• Source: Healthpoint
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: January 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Leg Ulcer
• Postphlebitic Syndrome
• Postthrombotic Syndrome
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcer
• Venous Stasis Ulcer

Locations

Country	Name	City	State
Canada	Aging Rehabilitation & Geriatric Care Research Center	London	Ontario
United States	Arlington Research Center	Arlington	Texas
United States	Johns Hopkins Wound Center	Baltimore	Maryland
United States	Lake Washington Vascular, PLLC	Bellevue	Washington
United States	Boston Medical Center	Boston	Massachusetts
United States	Center for Clinical Research	Castro Valley	California
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Northwestern University Feinberg School of Medicine	Chicago	Illinois
United States	Wound Care Consultants	Dallas	Texas
United States	Vincent Giacalone	Emerson	New Jersey
United States	ILD Consulting, Inc.	Encinitas	California
United States	Harrisburg Foot and Ankle Center	Harrisburg	Pennsylvania
United States	Passavant Area Hospital	Jacksonville	Illinois
United States	Advanced Foot and Ankle Center	Las Vegas	Nevada
United States	Vascular Surgery Associates	Los Angeles	California
United States	Southwest Regional Wound Care Center	Lubbock	Texas
United States	University of Miami	Miami	Florida
United States	St. Luke's Roosevelt Hospital Center	New York	New Jersey
United States	Rosalind Franklin University	North Chicago	Illinois
United States	Center for Advanced Wound Care	Reading	Pennsylvania
United States	Peripheral Vascular Associates	San Antonio	Texas
United States	UCSD Wound Treatment and Research Center	San Diego	California
United States	Doctors Research Network	South Miami	Florida
United States	Providence Sacred Heart Medical Center Wound Clinic	Spokane	Washington
United States	Southern Illinois University	Springfield	Illinois
United States	Dixie Regional Medical Center's Wound Clinic	St. George	Utah
United States	New England Sinai Hospital	Stoughton	Massachusetts
United States	Overglook Hospital Wound Healing Program	Summit	New Jersey
United States	Robert J. Snyder	Tamarac	Florida
United States	University of AZ College of Medicine	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Healthpoint

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Number of Participants With Closed Target Ulcers at Each Visit	At each visit the status of closed target ulcers was evaluated as remained closed or re-opened.	Over the 24-week study period, at each of the bi-monthly visits	No
Primary	Number of Subjects With Target Wound Closed for the First Time During the Study Period.	At each visit the status of open target ulcers was evaluated as "remained open" or "closed".	Over the 24-week study period, at each of the bi-monthly visits	No