Back to resultsStudy Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers
Primary Purpose
Venous Leg Ulcers
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
HP-802-247
Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Venous Leg Ulcers focused on measuring Venous leg ulcer, ulcer, venous stasis, compression, venous, venous stasis ulcer, vlu
Eligibility Criteria
Inclusion Criteria:
- Provide informed consent.
- Age ≥ 18 years and of either sex.
- Willing to comply with protocol instructions, including allowing all study assessments.
- Have a venous leg ulcer (VLU) between the knee and ankle (at or above the malleolus), with a surface area ≥ 2.0 cm2 and ≤ 12.0 cm2
- Venous insufficiency confirmed by duplex Doppler ultrasound examination for valvular or venous incompetence.
- Arterial supply adequacy confirmed
- Target ulcer involves a full thickness skin loss, but WITHOUT exposure of tendon, muscle, or bone.
- Target ulcer duration ≥ 6 weeks but ≤ 104 weeks (24 months).
- Acceptable state of health and nutrition
Exclusion Criteria:
- History of anaphylaxis, serum sickness, or erythema multiforme reaction to aprotinin, bovine serum albumin or bovine serum proteins, penicillin, streptomycin, amphotericin B.
- Prior diagnosis of Systemic Lupus Erythematosus with elevated anti-DNA antibody titers, Buerger's disease (thromboangiitis obliterans), current diagnosis of vasculitis, or current diagnosis of claudication.
- Therapy with another investigational agent within thirty (30) days of Screening, or during the study.
- A target ulcer of non-venous etiologies (e.g., sickle cell anemia, necrobiosis lipoidica diabeticorum, pyoderma gangrenosum, vasculopathic or vasculitic).
- Documented history of osteomyelitis at the target wound location within 6 months preceding the Screening Visit.
- Refusal of or inability to tolerate compression therapy.
- Therapy of the target ulcer with autologous skin graft, Apligraf™, or Dermagraft™ within 30 days preceding the Screening Visit.
- History of cancer in the preceding 5 years (other than carcinoma in situ of the cervix or adequately treated non-melanoma skin cancers).
- Any prior exposure to HP802-247 or its vehicle.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
HP802-247
Vehicle
Arm Description
HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days.
Vehicle Control (fibrinogen solution & thrombin solution without cells)
Outcomes
Primary Outcome Measures
Compare the Treatment Groups for the Proportion of Subjects With Complete Wound Closure Over the 12-Week Treatment Period From Baseline
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. Following initial closure subjects returned for four weekly visits to confirm wound closure. Wounds that remained closed for four weeks were classified as confirmed closures; if a wound opened at any of the 4 visits it was not considered to have closed. For subjects who dropped from the study, their remaining visit values were imputed using LOCF; wound status of closed was not imputed.
Secondary Outcome Measures
Compare the Efficacy of the Treatment Groups in Achieving Complete Wound Closure, Based on Time in Days to Closure Over the 12-Week Treatment Period From Baseline.
This key secondary outcome was based on a Cox Proportional Hazard Analysis and a Kaplan-Meier survival analysis.
Compare the Treatment Groups for the Percentage of Closed Ulcers at Each Visit of the 12-Week Treatment Period From Baseline
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.
Number of Subjects With Durable Wound Healing Over the 3 Months Following Complete Wound Closure
Subjects who completed the treatment period with confirmed wound closure were followed in the post-treatment period for a further two months to determine their closed wound status (remained closed/reopened), giving a measure of persistence of wound closure following completion of treatment.
Change in Pain Associated With the Target Leg at Each of the 12 Double Blind Treatment Weeks
Target leg pain were 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.
Change in Target Ulcer Pain
Target ulcer pain were 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.
Compare the Efficacy of the Treatment Groups in Achieving Complete Wound Closure, Based on the Median Time (in Days) to Closure Over the 12-Week Treatment Period From Baseline.
This key secondary outcome was based on a Kaplan-Meier survival analysis.
Full Information
NCT ID
NCT01656889
First Posted
August 1, 2012
Last Updated
February 16, 2016
Sponsor
Healthpoint
Collaborators
Smith & Nephew, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01656889
Brief Title
Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers
Official Title
A Phase 3 Randomized, Double Blind, Vehicle Controlled Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Healthpoint
Collaborators
Smith & Nephew, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is being done to find out if an investigational product called HP802-247 can help people with venous leg ulcers. Investigational means that HP802-247 has not been approved by the U.S. Food and Drug Administration (FDA).
This research is being done to compare the efficacy of HP802-247 plus compression therapy against Vehicle plus compression therapy in achieving complete wound closure over the 12-week treatment period. Vehicle looks the same as HP802-247 but contains no cells.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Leg Ulcers
Keywords
Venous leg ulcer, ulcer, venous stasis, compression, venous, venous stasis ulcer, vlu
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
447 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HP802-247
Arm Type
Experimental
Arm Description
HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days.
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Vehicle Control (fibrinogen solution & thrombin solution without cells)
Intervention Type
Biological
Intervention Name(s)
HP-802-247
Intervention Description
HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days.
Intervention Type
Biological
Intervention Name(s)
Vehicle
Intervention Description
(fibrinogen solution & thrombin solution without cells)
Primary Outcome Measure Information:
Title
Compare the Treatment Groups for the Proportion of Subjects With Complete Wound Closure Over the 12-Week Treatment Period From Baseline
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. Following initial closure subjects returned for four weekly visits to confirm wound closure. Wounds that remained closed for four weeks were classified as confirmed closures; if a wound opened at any of the 4 visits it was not considered to have closed. For subjects who dropped from the study, their remaining visit values were imputed using LOCF; wound status of closed was not imputed.
Time Frame
12 Weeks
Secondary Outcome Measure Information:
Title
Compare the Efficacy of the Treatment Groups in Achieving Complete Wound Closure, Based on Time in Days to Closure Over the 12-Week Treatment Period From Baseline.
Description
This key secondary outcome was based on a Cox Proportional Hazard Analysis and a Kaplan-Meier survival analysis.
Time Frame
12 Weeks
Title
Compare the Treatment Groups for the Percentage of Closed Ulcers at Each Visit of the 12-Week Treatment Period From Baseline
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, or until wound closure, which ever occurred first
Title
Number of Subjects With Durable Wound Healing Over the 3 Months Following Complete Wound Closure
Description
Subjects who completed the treatment period with confirmed wound closure were followed in the post-treatment period for a further two months to determine their closed wound status (remained closed/reopened), giving a measure of persistence of wound closure following completion of treatment.
Time Frame
Target ulcer status observed at two and three months following initial ulcer closure.
Title
Change in Pain Associated With the Target Leg at Each of the 12 Double Blind Treatment Weeks
Description
Target leg pain were 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.
Time Frame
Weekly, over the 12 week treatment period, baseline
Title
Change in Target Ulcer Pain
Description
Target ulcer pain were 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.
Time Frame
Weekly, over 12 week treament period, baseline
Title
Compare the Efficacy of the Treatment Groups in Achieving Complete Wound Closure, Based on the Median Time (in Days) to Closure Over the 12-Week Treatment Period From Baseline.
Description
This key secondary outcome was based on a Kaplan-Meier survival analysis.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Provide informed consent.
Age ≥ 18 years and of either sex.
Willing to comply with protocol instructions, including allowing all study assessments.
Have a venous leg ulcer (VLU) between the knee and ankle (at or above the malleolus), with a surface area ≥ 2.0 cm2 and ≤ 12.0 cm2
Venous insufficiency confirmed by duplex Doppler ultrasound examination for valvular or venous incompetence.
Arterial supply adequacy confirmed
Target ulcer involves a full thickness skin loss, but WITHOUT exposure of tendon, muscle, or bone.
Target ulcer duration ≥ 6 weeks but ≤ 104 weeks (24 months).
Acceptable state of health and nutrition
Exclusion Criteria:
History of anaphylaxis, serum sickness, or erythema multiforme reaction to aprotinin, bovine serum albumin or bovine serum proteins, penicillin, streptomycin, amphotericin B.
Prior diagnosis of Systemic Lupus Erythematosus with elevated anti-DNA antibody titers, Buerger's disease (thromboangiitis obliterans), current diagnosis of vasculitis, or current diagnosis of claudication.
Therapy with another investigational agent within thirty (30) days of Screening, or during the study.
A target ulcer of non-venous etiologies (e.g., sickle cell anemia, necrobiosis lipoidica diabeticorum, pyoderma gangrenosum, vasculopathic or vasculitic).
Documented history of osteomyelitis at the target wound location within 6 months preceding the Screening Visit.
Refusal of or inability to tolerate compression therapy.
Therapy of the target ulcer with autologous skin graft, Apligraf™, or Dermagraft™ within 30 days preceding the Screening Visit.
History of cancer in the preceding 5 years (other than carcinoma in situ of the cervix or adequately treated non-melanoma skin cancers).
Any prior exposure to HP802-247 or its vehicle.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Herbert B Slade, MD
Organizational Affiliation
Chief Medical Officer
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Tommy Lee, MSHS
Organizational Affiliation
Associate Director Clinical Operations
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Robert Kirsner, MD
Organizational Affiliation
Investigator
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
William Marston, MD
Organizational Affiliation
Investigator
Official's Role
Principal Investigator
Facility Information:
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85723
Country
United States
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
City
Carlsbad
State/Province
California
ZIP/Postal Code
92009
Country
United States
City
Castro Valley
State/Province
California
ZIP/Postal Code
94546
Country
United States
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92013
Country
United States
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
City
Stockton
State/Province
California
ZIP/Postal Code
95204
Country
United States
City
Sylmar
State/Province
California
ZIP/Postal Code
91342
Country
United States
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33013
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60616
Country
United States
City
Jacksonville
State/Province
Illinois
ZIP/Postal Code
62650
Country
United States
City
North Chicago
State/Province
Illinois
ZIP/Postal Code
60064
Country
United States
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02138
Country
United States
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
City
Emerson
State/Province
New Jersey
ZIP/Postal Code
07630
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
City
Akron
State/Province
Ohio
ZIP/Postal Code
44307
Country
United States
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74127
Country
United States
City
Dunmore
State/Province
Pennsylvania
ZIP/Postal Code
18512
Country
United States
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76107
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
City
St. George
State/Province
Utah
ZIP/Postal Code
84770
Country
United States
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24013
Country
United States
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98431
Country
United States
City
Vancovuer
State/Province
British Columbia
ZIP/Postal Code
V5Z1M9
Country
Canada
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8R2R3
Country
Canada
City
London
State/Province
Ontario
ZIP/Postal Code
N6C5J1
Country
Canada
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E5J1
Country
Canada
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H5N4
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
29037354
Citation
Marston WA, Ennis WJ, Lantis JC 2nd, Kirsner RS, Galiano RD, Vanscheidt W, Eming SA, Malka M, Cargill DI, Dickerson JE Jr, Slade HB; HP802-247 Study Group. Baseline factors affecting closure of venous leg ulcers. J Vasc Surg Venous Lymphat Disord. 2017 Nov;5(6):829-835.e1. doi: 10.1016/j.jvsv.2017.06.017.
Results Reference
derived
Learn more about this trial
Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers
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