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Dose Finding Study of HP802-247 in Venous Leg Ulcers

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ClinicalTrials.gov Identifier: NCT00852995
Recruitment Status : Completed
First Posted : February 27, 2009
Results First Posted : March 14, 2016
Last Update Posted : October 24, 2016
Sponsor:
Information provided by (Responsible Party):
Healthpoint

Study Description
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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.

Condition or disease Intervention/treatment Phase
Venous Leg Ulcer Venous Stasis Ulcers Biological: HP802-247 Biological: Placebo (Vehicle) Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 228 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II Randomized, Double Blind, Placebo Controlled Dose Finding Study Investigating the Efficacy of HP802-247 in Venous Leg Ulcers
Study Start Date : February 2009
Actual Primary Completion Date : April 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: A - Low Q7D
Low dose HP802-247, applied at each visit
 Biological: HP802-247
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.
Experimental: B - Low Q14D
Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12
 Biological: HP802-247
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.
Experimental: C - High Q7D
High dose HP802-247, applied at each visit
 Biological: HP802-247
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.
Experimental: D - High Q14D
High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12
 Biological: HP802-247
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.
Placebo Comparator: E - Vehicle
Placebo (Vehicle), applied at each visit
 Biological: Placebo (Vehicle)

Placebo (Vehicle) consisting of:

Component 1 - acellular fibrinogen solution; Component 2 - acellular thrombin solution


Outcome Measures
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Primary Outcome Measures :
  1. The Average Percent (%) Change From Baseline in the Target Wound Area in Each Treatment Group Over the Twelve-week Double-blind Treatment Period. [ Time Frame: Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first ]
    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 :
  1. Kaplan-Meier Probability of Non-Closure [ Time Frame: 14 weeks - the final visit for one subject was delayed by two weeks ]
    This key secondary outcome was the days to wound closure based on a Kaplan-Meier survival analysis.

  2. Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks. [ Time Frame: Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first ]
    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.

  3. Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13 [ Time Frame: Over the 12 week treatment period or until the wound closed, which ever occurred first. ]
    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.

  4. Percentage of Participants With Complete Wound Closure at Each Visit [ Time Frame: Weekly, over the 12 week treatment period ]
    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.

  5. 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. [ Time Frame: Weekly, over the 12 week treatment period ]
    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.

  6. Median Time to Achieve Complete Wound Closure, Based on Based on a Kaplan-Meier Survival Analysis, Over the 12-Week Treatment Period From Baseline. [ Time Frame: 14 weeks - the final visit for one subject was delayed by two weeks ]
    This key secondary outcome was the days to wound closure based on a Kaplan-Meier survival analysis.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00852995


  Show 30 Study Locations
Sponsors and Collaborators
Healthpoint
Investigators
Study Chair: Herbert B Slade, MD Healthpoint
Principal Investigator: William Marston, MD University of North Carolina
Principal Investigator: Robert Kirsner, MD University of Miami
Principal Investigator: Robert J Snyder, MD Robert J Snyder
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Healthpoint
ClinicalTrials.gov Identifier: NCT00852995     History of Changes
Other Study ID Numbers: 802-247-09-015
First Posted: February 27, 2009    Key Record Dates
Results First Posted: March 14, 2016
Last Update Posted: October 24, 2016
Last Verified: September 2016

Keywords provided by Healthpoint:
Venous Leg Ulcer (VLU)
Venous Stasis Ulcer (VSU)
VLU
 VSU
Leg Ulcer
Leg Wound

Additional relevant MeSH terms:
Ulcer
Leg Ulcer
Varicose Ulcer
Postphlebitic Syndrome
Postthrombotic Syndrome
Pathologic Processes
Skin Ulcer
Skin Diseases
Varicose Veins
 Vascular Diseases
Cardiovascular Diseases
Phlebitis
Peripheral Vascular Diseases
Venous Insufficiency
Venous Thrombosis
Thrombosis
Embolism and Thrombosis