Clinical trial NCT01658618: Safety Study Providing 12 Months Follow-up From First Exposure to HP802-247 in Subjects With Venous Leg Ulcer
Official title: A Non-Interventional Safety Study Providing 12 Months Follow-up From First Exposure to HP802-247 in Subjects With Venous Leg Ulcer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Venous Leg Ulcer
Keywords: Venous leg ulcer
ulcer
venous stasis
compression
venous
venous stasis ulcer
vlu
hp802-247-09-029
Lead sponsor: Healthpoint
Sponsor class: INDUSTRY
First posted: 2012-08-07
Enrollment: 440
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: The cohorts will be carried over and include all subjects who were randomized in 802-247-09-029 and received at least one application of a test article. Subjects will be enrolled based on participation in the 802-247-09-029 trial, evidenced by randomization and completion (or discontinuation) in that trial and having received at least one application of test article.

Brief 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Primary Objective
timeFrame: 12 months
Secondary outcomes:
measure: Exploratory Objectives
timeFrame: 12 Months
Other outcomes:
Locations:
city: Glendale
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Carlsbad
country: United States
state: California
city: Castro Valley
country: United States
state: California
city: Laguna Hills
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Stockton
country: United States
state: California
city: Sylmar
country: United States
state: California
city: Washington
country: United States
state: District of Columbia
city: Gainesville
country: United States
state: Florida
city: Hialeah
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: South Miami
country: United States
state: Florida
city: Tamarac
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Jacksonville
country: United States
state: Illinois
city: North Chicago
country: United States
state: Illinois
city: Springfield
country: United States
state: Illinois
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Cambridge
country: United States
state: Massachusetts
city: Las Vegas
country: United States
state: Nevada
city: Emerson
country: United States
state: New Jersey
city: New York
country: United States
state: New York
city: Chapel Hill
country: United States
state: North Carolina
city: Akron
country: United States
state: Ohio
city: Tulsa
country: United States
state: Oklahoma
city: Dunmore
country: United States
state: Pennsylvania
city: Wyomissing
country: United States
state: Pennsylvania
city: Dallas
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: St. George
country: United States
state: Utah
city: Roanoke
country: United States
state: Virginia
city: Tacoma
country: United States
state: Washington
city: Vancouver
country: Canada
state: British Columbia
city: Hamilton
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Sudbury
country: Canada
state: Ontario
city: Sherbrooke
country: Canada
state: Quebec
Study officials:
affiliation: Chief Medical Officer
name: Herbert B Slade, MD
role: STUDY_CHAIR
affiliation: Associate Director Clinical Operations
name: Tommy Lee, MSHS
role: STUDY_DIRECTOR
affiliation: Investigator
name: Robert Kirsner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Investigator
name: William Marston, MD
role: PRINCIPAL_INVESTIGATOR
References: