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Dose Finding Study of HP802-247 in Venous Leg Ulcers

Primary Purpose

Venous Leg Ulcer, Venous Stasis Ulcers

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
HP802-247
Placebo (Vehicle)
Sponsored by
Healthpoint
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Leg Ulcer focused on measuring Venous Leg Ulcer (VLU), Venous Stasis Ulcer (VSU), VLU, VSU, Leg Ulcer, Leg Wound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Provide informed consent.
  • Willing to comply with protocol instructions, including allowing all study assessments.
  • Have a venous leg ulcer (venous etiology)between the knee and ankle, at or above the malleolus.
  • Venous insufficiency confirmed by duplex Doppler ultrasound examination for valvular or venous incompetence.
  • Target ulcer duration greater than or equal to 6 weeks but less than or equal to 24 months.

Exclusion Criteria:

  • Women who are pregnant or lactating
  • Therapy with another investigational agent within thirty (30) days of Screening, or during the study.
  • A target ulcer of non-venous etiologies.
  • Refusal of or inability to tolerate compression therapy.
  • Therapy of the target ulcer with tissue-engineered cell-based skin equivalents within 30 days preceding the Screening Visit.
  • Therapy of the target ulcer with topical growth factors within 1 week preceding the Screening Visit.

Sites / Locations

  • University of AZ College of Medicine
  • Center for Clinical Research
  • ILD Consulting, Inc.
  • Vascular Surgery Associates
  • UCSD Wound Treatment and Research Center
  • University of Miami
  • Doctors Research Network
  • Robert J. Snyder
  • Northwestern University Feinberg School of Medicine
  • Passavant Area Hospital
  • Rosalind Franklin University
  • Southern Illinois University
  • Johns Hopkins Wound Center
  • Boston Medical Center
  • New England Sinai Hospital
  • Advanced Foot and Ankle Center
  • Vincent Giacalone
  • St. Luke's Roosevelt Hospital Center
  • Overlook Hospital Wound Healing Program
  • University of North Carolina
  • Harrisburg Foot and Ankle Center
  • Center for Advanced Wound Care
  • Arlington Research Center
  • Wound Care Consultants
  • Southwest Regional Wound Care Center
  • Peripheral Vascular Associates
  • Dixie Regional Medical Center's Wound Clinic
  • Lake Washington Vascular, LLC
  • Providence Sacred Heart Medical Center Wound Clinic
  • Aging Rehabilitation & Geriatric Care Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

A - Low Q7D

B - Low Q14D

C - High Q7D

D - High Q14D

E - Vehicle

Arm Description

Low dose HP802-247, applied at each visit

Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12

High dose HP802-247, applied at each visit

High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12

Placebo (Vehicle), applied at each visit

Outcomes

Primary Outcome Measures

The Average Percent (%) Change From Baseline in the Target Wound Area in Each Treatment Group Over the Twelve-week Double-blind Treatment Period.
For each treatment group the area of each subject's target ulcer was measured on a weekly basis, for up to 12 weeks, or until wound closure, whichever occurred first, using a laser-based wound imaging system in conjunction with software to measure area. An average of the 12 measurements were assessed.

Secondary Outcome Measures

Kaplan-Meier Probability of Non-Closure
This key secondary outcome was the days to wound closure based on a Kaplan-Meier survival analysis.
Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks.
For each treatment group the area of each subject's target ulcer was measured on a weekly basis, for up to 12 weeks, using a laser-based wound imaging system in conjunction with software to measure area.
Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13
The area of each subject's target wound was measured at each visit and the proportion of subjects with a decrease in area from baseline ≥ 50% was calculated for each treatment group.
Percentage of Participants With Complete Wound Closure at Each Visit
Treatment groups were compared for the proportion of wounds closed at each weekly visit. For subjects who dropped from the study, their remaining visit values were imputed using LOCF.
Target Ulcer Pain Was Measured Using a Visual Analog Scale [Range: 0mm - 100mm]. Subjects Marked Their Pain Level on a 100 mm Horizontal Line, With a Short Vertical Line Across the Scale, 0 Denoting no Pain and 100mm the Maximum Pain.
Target ulcer pain was measured using a Visual Analog Scale [Range: 0mm - 100mm]. Subjects marked their pain level on a 100 mm horizontal line, with a short vertical line across the scale, 0 denoting no pain and 100mm the maximum pain. Each weekly measurement is reported as the average of all subjects scores at each week per treatment group.
Median Time to Achieve Complete Wound Closure, Based on Based on a Kaplan-Meier Survival Analysis, Over the 12-Week Treatment Period From Baseline.
This key secondary outcome was the days to wound closure based on a Kaplan-Meier survival analysis.

Full Information

First Posted
February 26, 2009
Last Updated
September 13, 2016
Sponsor
Healthpoint
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1. Study Identification

Unique Protocol Identification Number
NCT00852995
Brief Title
Dose Finding Study of HP802-247 in Venous Leg Ulcers
Official Title
A Phase II Randomized, Double Blind, Placebo Controlled Dose Finding Study Investigating the Efficacy of HP802-247 in Venous Leg Ulcers
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Healthpoint

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a 16-week study for subjects with a venous leg ulcer between the knee and ankle. This research is being done to determine the effectiveness of two dosing frequencies and two different concentrations of HP802-247, together with standard care, compared to placebo, plus standard care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Leg Ulcer, Venous Stasis Ulcers
Keywords
Venous Leg Ulcer (VLU), Venous Stasis Ulcer (VSU), VLU, VSU, Leg Ulcer, Leg Wound

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
228 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A - Low Q7D
Arm Type
Experimental
Arm Description
Low dose HP802-247, applied at each visit
Arm Title
B - Low Q14D
Arm Type
Experimental
Arm Description
Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12
Arm Title
C - High Q7D
Arm Type
Experimental
Arm Description
High dose HP802-247, applied at each visit
Arm Title
D - High Q14D
Arm Type
Experimental
Arm Description
High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12
Arm Title
E - Vehicle
Arm Type
Placebo Comparator
Arm Description
Placebo (Vehicle), applied at each visit
Intervention Type
Biological
Intervention Name(s)
HP802-247
Intervention Description
One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.
Intervention Type
Biological
Intervention Name(s)
Placebo (Vehicle)
Intervention Description
Placebo (Vehicle) consisting of: Component 1 - acellular fibrinogen solution; Component 2 - acellular thrombin solution
Primary Outcome Measure Information:
Title
The Average Percent (%) Change From Baseline in the Target Wound Area in Each Treatment Group Over the Twelve-week Double-blind Treatment Period.
Description
For each treatment group the area of each subject's target ulcer was measured on a weekly basis, for up to 12 weeks, or until wound closure, whichever occurred first, using a laser-based wound imaging system in conjunction with software to measure area. An average of the 12 measurements were assessed.
Time Frame
Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first
Secondary Outcome Measure Information:
Title
Kaplan-Meier Probability of Non-Closure
Description
This key secondary outcome was the days to wound closure based on a Kaplan-Meier survival analysis.
Time Frame
14 weeks - the final visit for one subject was delayed by two weeks
Title
Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks.
Description
For each treatment group the area of each subject's target ulcer was measured on a weekly basis, for up to 12 weeks, using a laser-based wound imaging system in conjunction with software to measure area.
Time Frame
Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first
Title
Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13
Description
The area of each subject's target wound was measured at each visit and the proportion of subjects with a decrease in area from baseline ≥ 50% was calculated for each treatment group.
Time Frame
Over the 12 week treatment period or until the wound closed, which ever occurred first.
Title
Percentage of Participants With Complete Wound Closure at Each Visit
Description
Treatment groups were compared for the proportion of wounds closed at each weekly visit. For subjects who dropped from the study, their remaining visit values were imputed using LOCF.
Time Frame
Weekly, over the 12 week treatment period
Title
Target Ulcer Pain Was Measured Using a Visual Analog Scale [Range: 0mm - 100mm]. Subjects Marked Their Pain Level on a 100 mm Horizontal Line, With a Short Vertical Line Across the Scale, 0 Denoting no Pain and 100mm the Maximum Pain.
Description
Target ulcer pain was measured using a Visual Analog Scale [Range: 0mm - 100mm]. Subjects marked their pain level on a 100 mm horizontal line, with a short vertical line across the scale, 0 denoting no pain and 100mm the maximum pain. Each weekly measurement is reported as the average of all subjects scores at each week per treatment group.
Time Frame
Weekly, over the 12 week treatment period
Title
Median Time to Achieve Complete Wound Closure, Based on Based on a Kaplan-Meier Survival Analysis, Over the 12-Week Treatment Period From Baseline.
Description
This key secondary outcome was the days to wound closure based on a Kaplan-Meier survival analysis.
Time Frame
14 weeks - the final visit for one subject was delayed by two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Provide informed consent. Willing to comply with protocol instructions, including allowing all study assessments. Have a venous leg ulcer (venous etiology)between the knee and ankle, at or above the malleolus. Venous insufficiency confirmed by duplex Doppler ultrasound examination for valvular or venous incompetence. Target ulcer duration greater than or equal to 6 weeks but less than or equal to 24 months. Exclusion Criteria: Women who are pregnant or lactating Therapy with another investigational agent within thirty (30) days of Screening, or during the study. A target ulcer of non-venous etiologies. Refusal of or inability to tolerate compression therapy. Therapy of the target ulcer with tissue-engineered cell-based skin equivalents within 30 days preceding the Screening Visit. Therapy of the target ulcer with topical growth factors within 1 week preceding the Screening Visit.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Herbert B Slade, MD
Organizational Affiliation
Healthpoint
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
William Marston, MD
Organizational Affiliation
University of North Carolina
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert Kirsner, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert J Snyder, MD
Organizational Affiliation
Robert J Snyder
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of AZ College of Medicine
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Center for Clinical Research
City
Castro Valley
State/Province
California
ZIP/Postal Code
94546
Country
United States
Facility Name
ILD Consulting, Inc.
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Vascular Surgery Associates
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
UCSD Wound Treatment and Research Center
City
San Diego
State/Province
California
ZIP/Postal Code
92013
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Facility Name
Doctors Research Network
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Robert J. Snyder
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
Northwestern University Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60154
Country
United States
Facility Name
Passavant Area Hospital
City
Jacksonville
State/Province
Illinois
ZIP/Postal Code
62650
Country
United States
Facility Name
Rosalind Franklin University
City
North Chicago
State/Province
Illinois
ZIP/Postal Code
60064
Country
United States
Facility Name
Southern Illinois University
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
Johns Hopkins Wound Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
New England Sinai Hospital
City
Stoughton
State/Province
Massachusetts
ZIP/Postal Code
02972
Country
United States
Facility Name
Advanced Foot and Ankle Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Vincent Giacalone
City
Emerson
State/Province
New Jersey
ZIP/Postal Code
07630
Country
United States
Facility Name
St. Luke's Roosevelt Hospital Center
City
New York
State/Province
New Jersey
ZIP/Postal Code
10025
Country
United States
Facility Name
Overlook Hospital Wound Healing Program
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07901
Country
United States
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Harrisburg Foot and Ankle Center
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17112
Country
United States
Facility Name
Center for Advanced Wound Care
City
Reading
State/Province
Pennsylvania
ZIP/Postal Code
19601
Country
United States
Facility Name
Arlington Research Center
City
Arlington
State/Province
Texas
ZIP/Postal Code
76011
Country
United States
Facility Name
Wound Care Consultants
City
Dallas
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Southwest Regional Wound Care Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
Facility Name
Peripheral Vascular Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78205
Country
United States
Facility Name
Dixie Regional Medical Center's Wound Clinic
City
St. George
State/Province
Utah
ZIP/Postal Code
84770
Country
United States
Facility Name
Lake Washington Vascular, LLC
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
Providence Sacred Heart Medical Center Wound Clinic
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Aging Rehabilitation & Geriatric Care Research Center
City
London
State/Province
Ontario
ZIP/Postal Code
N6C5J1
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
22863328
Citation
Kirsner RS, Marston WA, Snyder RJ, Lee TD, Cargill DI, Slade HB. Spray-applied cell therapy with human allogeneic fibroblasts and keratinocytes for the treatment of chronic venous leg ulcers: a phase 2, multicentre, double-blind, randomised, placebo-controlled trial. Lancet. 2012 Sep 15;380(9846):977-85. doi: 10.1016/S0140-6736(12)60644-8. Epub 2012 Aug 3.
Results Reference
derived

Learn more about this trial

Dose Finding Study of HP802-247 in Venous Leg Ulcers

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