Dose Finding Study of HP802-247 in Venous Leg Ulcers
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00852995 |
Recruitment Status
:
Completed
First Posted
: February 27, 2009
Results First Posted
: March 14, 2016
Last Update Posted
: October 24, 2016
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Venous Leg Ulcer Venous Stasis Ulcers | Biological: HP802-247 Biological: Placebo (Vehicle) | Phase 2 |
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 |

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 |
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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

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 |
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 |