Clinical trial NCT00900029: Safety Follow-Up to HP 802-247-09-015
Official title: A Twenty-Four Week Non-Interventional Safety Follow-Up to HP 802-247-09-015
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Leg Ulcer
Venous Stasis Ulcer
Keywords: Venous Leg Ulcer
Venous Stasis Ulcer
VLU
VSU
Leg Ulcer
Leg Wound
Lead sponsor: Healthpoint
Sponsor class: INDUSTRY
First posted: 2009-05-12
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who participated in Study No. 802-247-09-015 - "A Phase II Randomized, Double Blind, Placebo Controlled Dose Finding Study Investigating the Efficacy of HP802-247 in Venous Leg Ulcers" and agreed to continue with the follow-up study.

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

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: The Number of Participants With Closed Target Ulcers at Each Visit
timeFrame: Over the 24-week study period, at each of the bi-monthly visits
measure: Number of Subjects With Target Wound Closed for the First Time During the Study Period.
timeFrame: Over the 24-week study period, at each of the bi-monthly visits
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of AZ College of Medicine
state: Arizona
city: Castro Valley
country: United States
facility: Center for Clinical Research
state: California
city: Encinitas
country: United States
facility: ILD Consulting, Inc.
state: California
city: Los Angeles
country: United States
facility: Vascular Surgery Associates
state: California
city: San Diego
country: United States
facility: UCSD Wound Treatment and Research Center
state: California
city: Miami
country: United States
facility: University of Miami
state: Florida
city: South Miami
country: United States
facility: Doctors Research Network
state: Florida
city: Tamarac
country: United States
facility: Robert J. Snyder
state: Florida
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
city: Jacksonville
country: United States
facility: Passavant Area Hospital
state: Illinois
city: North Chicago
country: United States
facility: Rosalind Franklin University
state: Illinois
city: Springfield
country: United States
facility: Southern Illinois University
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins Wound Center
state: Maryland
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Stoughton
country: United States
facility: New England Sinai Hospital
state: Massachusetts
city: Las Vegas
country: United States
facility: Advanced Foot and Ankle Center
state: Nevada
city: Emerson
country: United States
facility: Vincent Giacalone
state: New Jersey
city: New York
country: United States
facility: St. Luke's Roosevelt Hospital Center
state: New Jersey
city: Summit
country: United States
facility: Overglook Hospital Wound Healing Program
state: New Jersey
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Harrisburg
country: United States
facility: Harrisburg Foot and Ankle Center
state: Pennsylvania
city: Reading
country: United States
facility: Center for Advanced Wound Care
state: Pennsylvania
city: Arlington
country: United States
facility: Arlington Research Center
state: Texas
city: Dallas
country: United States
facility: Wound Care Consultants
state: Texas
city: Lubbock
country: United States
facility: Southwest Regional Wound Care Center
state: Texas
city: San Antonio
country: United States
facility: Peripheral Vascular Associates
state: Texas
city: Saint George
country: United States
facility: Dixie Regional Medical Center's Wound Clinic
state: Utah
city: Bellevue
country: United States
facility: Lake Washington Vascular, PLLC
state: Washington
city: Spokane
country: United States
facility: Providence Sacred Heart Medical Center Wound Clinic
state: Washington
city: London
country: Canada
facility: Aging Rehabilitation & Geriatric Care Research Center
state: Ontario
Study officials:
affiliation: Healthpoint
name: Hebert B Slade, MD, FAAAAI
role: STUDY_DIRECTOR
References: