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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A - Low Q7D | Experimental | Low dose HP802-247, applied at each visit |
|
| B - Low Q14D | Experimental | Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12 |
|
| C - High Q7D | Experimental | High dose HP802-247, applied at each visit |
|
| D - High Q14D | Experimental | High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12 |
|
| E - Vehicle | Placebo Comparator | Placebo (Vehicle), applied at each visit |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HP802-247 | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first |
| Measure | Description | Time Frame |
|---|---|---|
| Kaplan-Meier Probability of Non-Closure | This key secondary outcome was the days to wound closure based on a Kaplan-Meier survival analysis. | 14 weeks - the final visit for one subject was delayed by two weeks |
| Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Herbert B Slade, MD | Healthpoint | Study Chair |
| William Marston, MD | University of North Carolina | Principal Investigator |
| Robert Kirsner, MD | University of Miami | Principal Investigator |
| Robert J Snyder, MD | Robert J Snyder | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of AZ College of Medicine | Tucson | Arizona | 85724 | United States | ||
| Center for Clinical Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22863328 | Derived | 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. |
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Subjects entered a 2-week run-in; subjects whose wound radius decreased by < 0.349 cm/2weeks and met all other inclusion/exclusion (I/E) criteria were eligible for randomization.
Subjects were screened at 34 sites in the US and one in Canada, between June 11, 2009 and May 5, 2011; sites included independent and hospital wound clinics and private practice sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 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. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Placebo (Vehicle) | Biological | Placebo (Vehicle) consisting of: Component 1 - acellular fibrinogen solution; Component 2 - acellular thrombin solution |
|
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. |
| Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first |
| 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. | Over the 12 week treatment period or until the wound closed, which ever occurred first. |
| 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. | 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. | 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. | Weekly, over the 12 week treatment period |
| 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. | 14 weeks - the final visit for one subject was delayed by two weeks |
| Castro Valley |
| California |
| 94546 |
| United States |
| ILD Consulting, Inc. | Encinitas | California | 92024 | United States |
| Vascular Surgery Associates | Los Angeles | California | 90048 | United States |
| UCSD Wound Treatment and Research Center | San Diego | California | 92013 | United States |
| University of Miami | Miami | Florida | 33186 | United States |
| Doctors Research Network | South Miami | Florida | 33143 | United States |
| Robert J. Snyder | Tamarac | Florida | 33321 | United States |
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60154 | United States |
| Passavant Area Hospital | Jacksonville | Illinois | 62650 | United States |
| Rosalind Franklin University | North Chicago | Illinois | 60064 | United States |
| Southern Illinois University | Springfield | Illinois | 62702 | United States |
| Johns Hopkins Wound Center | Baltimore | Maryland | 21231 | United States |
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| New England Sinai Hospital | Stoughton | Massachusetts | 02972 | United States |
| Advanced Foot and Ankle Center | Las Vegas | Nevada | 89119 | United States |
| Vincent Giacalone | Emerson | New Jersey | 07630 | United States |
| St. Luke's Roosevelt Hospital Center | New York | New Jersey | 10025 | United States |
| Overlook Hospital Wound Healing Program | Summit | New Jersey | 07901 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
| Harrisburg Foot and Ankle Center | Harrisburg | Pennsylvania | 17112 | United States |
| Center for Advanced Wound Care | Reading | Pennsylvania | 19601 | United States |
| Arlington Research Center | Arlington | Texas | 76011 | United States |
| Wound Care Consultants | Dallas | Texas | 75093 | United States |
| Southwest Regional Wound Care Center | Lubbock | Texas | 79410 | United States |
| Peripheral Vascular Associates | San Antonio | Texas | 78205 | United States |
| Dixie Regional Medical Center's Wound Clinic | St. George | Utah | 84770 | United States |
| Lake Washington Vascular, LLC | Bellevue | Washington | 98004 | United States |
| Providence Sacred Heart Medical Center Wound Clinic | Spokane | Washington | 99204 | United States |
| Aging Rehabilitation & Geriatric Care Research Center | London | Ontario | N6C5J1 | Canada |
| A - Low Q7D |
Low dose HP802-247, applied at each visit 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. |
| FG002 | 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 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. |
| FG003 | C - High Q7D | High dose HP802-247, applied at each visit 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. |
| FG004 | E - HP802-247 Vehicle | Placebo (Vehicle), applied at each visit Placebo (Vehicle): Placebo (Vehicle) consisting of: Component 1 - acellular fibrinogen solution; Component 2 - acellular thrombin solution |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | E - HP802-247 Vehicle | Placebo (Vehicle), applied at each visit Placebo (Vehicle): Placebo (Vehicle) consisting of: Component 1 - acellular fibrinogen solution; Component 2 - acellular thrombin solution |
| BG001 | 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 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. |
| BG002 | A - Low Q7D | Low dose HP802-247, applied at each visit 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. |
| BG003 | 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 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. |
| BG004 | C - High Q7D | High dose HP802-247, applied at each visit 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. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Mean | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | ITT population.: Subjects who received at least one dose of test article. The primary analysis was performed using a two-way ANCOVA model, which included treatment group (the effect of interest), site, and the baseline target wound area (the covariate), with significance being at P < 0.05. | Posted | Mean | Standard Deviation | percent change | Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Kaplan-Meier Probability of Non-Closure | This key secondary outcome was the days to wound closure based on a Kaplan-Meier survival analysis. | ITT Populations: Subjects who received at least one dose of test article. Data were analyzed using the Kaplan-Meier survival procedure, with significance being at P < 0.05. | Posted | Number | Probability of Non-Closure | 14 weeks - the final visit for one subject was delayed by two weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT population. Subjects who received at least one dose of test article. The data at each week were analyzed using a two-way ANCOVA model, which included treatment group (the effect of interest), site, and the baseline target wound area (the covariate). Significance was attained at P < 0.05. | Posted | Least Squares Mean | Standard Error | Percent change | Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The non-parametric Cochrane Mantel Haenszel test with adjustment for pooled site was used to examine treatment effects at each time point on the proportion of responders who have an average of ≥50% reduction from baseline in wound area over the treatment period. The test was performed separately for each pair of an active treatment vs. placebo. | Posted | Number | Responders | Over the 12 week treatment period or until the wound closed, which ever occurred first. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT Populations: Subjects who received at least one dose of test article. Analysis was by the Cochrane Mantel Haenszel (CMH) test | Posted | Number | percentage of participants | Weekly, over the 12 week treatment period |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT Populations: Subjects who received at least one dose of test article. Data were analyzed by an ANCOVA, adjusted for site and baseline score. | Posted | Mean | Standard Deviation | units on a scale | Weekly, over the 12 week treatment period |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT Populations: Subjects who received at least one dose of test article. Data were analyzed using the Kaplan-Meier survival procedure, with significance being at P < 0.05. | Posted | Median | 95% Confidence Interval | Days to Closure | 14 weeks - the final visit for one subject was delayed by two weeks |
|
The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | E - HP802-247 Vehicle | Placebo (Vehicle), applied at each visit Placebo (Vehicle): Placebo (Vehicle) consisting of: Component 1 - acellular fibrinogen solution; Component 2 - acellular thrombin solution | 4 | 50 | 26 | 50 | ||
| EG001 | 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 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. | 4 | 46 | 15 | 46 | ||
| EG002 | A - Low Q7D | Low dose HP802-247, applied at each visit 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. | 3 | 43 | 19 | 43 | ||
| EG003 | 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 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. | 3 | 43 | 16 | 44 | ||
| EG004 | C - High Q7D | High dose HP802-247, applied at each visit 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. | 2 | 45 | 17 | 45 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Splenic infarction | Blood and lymphatic system disorders | MedDRA v 12.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA v 12.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA v 12.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA v 12.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v 12.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA v 12.0 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA v 12.0 | Systematic Assessment |
| |
| Pneumonia pneumococcal | Infections and infestations | MedDRA v 12.0 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA v 12.0 | Systematic Assessment |
| |
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v 12.0 | Systematic Assessment |
| |
| Alcohol withdrawal syndrome | Psychiatric disorders | MedDRA v 12.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v 12.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v 12.0 | Systematic Assessment |
| |
| Excessive granulation tissue | Skin and subcutaneous tissue disorders | MedDRA v 12.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA v 12.0 | Systematic Assessment |
| |
| Peripheral vascular disorder | Vascular disorders | MedDRA v 12.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Disorders | Cardiac disorders | MedDRA v 12.0 | Systematic Assessment |
| |
| Gastrointestinal disorders | Gastrointestinal disorders | MedDRA v 12.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v 12.0 | Systematic Assessment |
| |
| General disorders and administration site conditions | General disorders | MedDRA v 12.0 | Systematic Assessment |
| |
| Infections and infestations | Infections and infestations | MedDRA v 12.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA v 12.0 | Systematic Assessment |
| |
| Infected skin ulcer | Infections and infestations | MedDRA v 12.0 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA v 12.0 | Systematic Assessment |
| |
| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | MedDRA v 12.0 | Systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | MedDRA v 12.0 | Systematic Assessment |
| |
| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | MedDRA v 12.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v 12.0 | Systematic Assessment |
| |
| Nervous system disorders | Nervous system disorders | MedDRA v 12.0 | Systematic Assessment |
| |
| Psychiatric disorders | Nervous system disorders | MedDRA v 12.0 | Systematic Assessment |
| |
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | MedDRA v 12.0 | Systematic Assessment |
| |
| Skin and subcutaneous | Skin and subcutaneous tissue disorders | MedDRA v 12.0 | Systematic Assessment |
| |
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA v 12.0 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA v 12.0 | Systematic Assessment |
| |
| Vascular disorders | Vascular disorders | MedDRA v 12.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jamie E Dickerson, PhD | Smith & Nephew | 1-817-302-3914 | Jaime.Dickerson@smith-nephew.com |
| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| D007871 | Leg Ulcer |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| Male Age |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 2-Sided |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.1586 | 2-Sided | No | Superiority or Other |
| t-test, 2 sided | 0.0295 | 2-Sided | No | Superiority or Other |
| OG003 | 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 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. |
| OG004 | C - High Q7D | High dose HP802-247, applied at each visit 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. |
|
|
Low dose HP802-247, applied at each visit 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. |
| OG003 | 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 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. |
| OG004 | C - High Q7D | High dose HP802-247, applied at each visit 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. |
|
|
|
Low dose HP802-247, applied at each visit 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. |
| OG003 | 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 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. |
| OG004 | C - High Q7D | High dose HP802-247, applied at each visit 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. |
|
|
|
| OG003 | 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 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. |
| OG004 | C - High Q7D | High dose HP802-247, applied at each visit 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. |
|
|
|
| A - Low Q7D |
Low dose HP802-247, applied at each visit 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. |
| OG003 | 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 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. |
| OG004 | C - High Q7D | High dose HP802-247, applied at each visit 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. |
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| OG003 | 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 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. |
| OG004 | C - High Q7D | High dose HP802-247, applied at each visit 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. |
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