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| Name | Class |
|---|---|
| Smith & Nephew, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HP802-247 | Experimental | 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 | Placebo Comparator | Vehicle Control (fibrinogen solution & thrombin solution without cells) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HP-802-247 | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 Weeks |
| Compare the Treatment Groups for the Percentage of Closed Ulcers at Each Visit of the 12-Week Treatment Period From Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Herbert B Slade, MD | Chief Medical Officer | Study Chair |
| Tommy Lee, MSHS | Associate Director Clinical Operations | Study Director |
| Robert Kirsner, MD | Investigator | Principal Investigator |
| William Marston, MD | Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glendale | Arizona | 85306 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29037354 | Derived | 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. |
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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. After completion of the treatment period, subjects entered a three-month follow up period.
Subjects were screened at 43 sites in the US and 5 in Canada; between August 22, 2012 and April 18, 2014; sites included independent and hospital wound clinics and private practice sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | HP802-247 | 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. HP-802-247: 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period, 12 Weeks |
|
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| Vehicle | Biological | (fibrinogen solution & thrombin solution without cells) |
|
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, or until wound closure, which ever occurred first |
| 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. | Target ulcer status observed at two and three months following initial ulcer closure. |
| 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. | Weekly, over the 12 week treatment period, baseline |
| 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. | Weekly, over 12 week treament period, baseline |
| 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. | 12 weeks |
| Phoenix |
| Arizona |
| 85006 |
| United States |
| Phoenix | Arizona | 85012 | United States |
| Tucson | Arizona | 85723 | United States |
| Tucson | Arizona | 85724 | United States |
| Carlsbad | California | 92009 | United States |
| Castro Valley | California | 94546 | United States |
| Fresno | California | 93720 | United States |
| Laguna Hills | California | 92653 | United States |
| Long Beach | California | 90822 | United States |
| Los Angeles | California | 90095 | United States |
| San Diego | California | 92013 | United States |
| San Francisco | California | 94115 | United States |
| Stockton | California | 95204 | United States |
| Sylmar | California | 91342 | United States |
| Washington D.C. | District of Columbia | 20007 | United States |
| Gainesville | Florida | 32605 | United States |
| Hialeah | Florida | 33013 | United States |
| Miami | Florida | 33125 | United States |
| South Miami | Florida | 33143 | United States |
| Tamarac | Florida | 33321 | United States |
| Chicago | Illinois | 60611 | United States |
| Chicago | Illinois | 60612 | United States |
| Chicago | Illinois | 60616 | United States |
| Jacksonville | Illinois | 62650 | United States |
| North Chicago | Illinois | 60064 | United States |
| Springfield | Illinois | 62702 | United States |
| Baltimore | Maryland | 21224 | United States |
| Boston | Massachusetts | 02118 | United States |
| Cambridge | Massachusetts | 02138 | United States |
| Las Vegas | Nevada | 89119 | United States |
| Emerson | New Jersey | 07630 | United States |
| New York | New York | 10025 | United States |
| Chapel Hill | North Carolina | 27599 | United States |
| Akron | Ohio | 44307 | United States |
| Tulsa | Oklahoma | 74127 | United States |
| Dunmore | Pennsylvania | 18512 | United States |
| Wyomissing | Pennsylvania | 19610 | United States |
| Dallas | Texas | 75390 | United States |
| Fort Worth | Texas | 76104 | United States |
| Fort Worth | Texas | 76107 | United States |
| San Antonio | Texas | 78229 | United States |
| St. George | Utah | 84770 | United States |
| Roanoke | Virginia | 24013 | United States |
| Tacoma | Washington | 98431 | United States |
| Vancovuer | British Columbia | V5Z1M9 | Canada |
| Greater Sudbury | Ontario | P3E5J1 | Canada |
| Hamilton | Ontario | L8R2R3 | Canada |
| London | Ontario | N6C5J1 | Canada |
| Sherbrooke | Quebec | J1H5N4 | Canada |
| FG001 | Vehicle | Vehicle Control (fibrinogen solution & thrombin solution without cells) Vehicle |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Post Treatment Follow-Up, 3 Months |
|
|
ITT population
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| ID | Title | Description |
|---|---|---|
| BG000 | HP802-247 | 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. HP-802-247: 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. |
| BG001 | Vehicle | Vehicle Control (fibrinogen solution & thrombin solution without cells) Vehicle |
| BG002 | 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | 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 | 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. | ITT Populations: Subjects who received at least one dose of test article. Analysis was by the Cochrane Mantel Haenszel (CMH) test, adjusted for sites, with significance being at P < 0.05 | Posted | Number | participants | 12 Weeks |
|
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|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT Populations: Subjects who received at least one dose of test article. Data were analyzed using the Cox Proportional hazard procedure, with significance being at P < 0.05 and by the Kaplan-Meier survival procedure | Posted | Median | Full Range | days | 12 Weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT Populations: Subjects who received at least one dose of test article. Analysis was by the Cochrane Mantel Haenszel (CMH) test, adjusted for sites, with significance being at P < 0.05 | Posted | Number | percentage of Closed Ulcers | Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The 285 subjects (HP802-247: 141/222; Vehicle: 144/225) who completed the treatment period with confirmed wound closure. Subjects returning for Visit 1 with confirmed wound closure at end of treatment: 134 HP802-247 and 132 Vehicle. Subjects returning for Visit 2 with confirmed wound closure at end of treatment: 132 HP802-247 and 131 Vehicle | Posted | Number | participants | Target ulcer status observed at two and three months following initial ulcer closure. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | 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 | Least Squares Mean | Standard Error | units on a scale | Weekly, over the 12 week treatment period, baseline |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | 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 | Least Squares Mean | Standard Error | units on a scale | Weekly, over 12 week treament period, baseline |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT Populations: Subjects who received at least one dose of test article. Data were analyzed using a Kaplan-Meier Survival Analysis, with significance being at P < 0.05. | Posted | Median | Full Range | days to wound closure | 12 weeks |
|
|
Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-treatment period
All subjects randomized to treatment were questioned about AE 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 AE. Some AE were only collected with respect to the organ system class.
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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 | HP802-247 | 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. HP-802-247: 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. | 17 | 222 | 119 | 222 | ||
| EG001 | Vehicle | Vehicle Control (fibrinogen solution & thrombin solution without cells) Vehicle | 21 | 225 | 107 | 225 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA v 13.1 | Systematic Assessment |
| |
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA v 13.1 | Systematic Assessment |
| |
| Artrial fibrillation | Cardiac disorders | MedDRA v 13.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA v 13.1 | Systematic Assessment |
| |
| Hypertensive heart disease | Cardiac disorders | MedDRA v 13.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA v 13.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA v 13.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v 13.1 | Systematic Assessment |
| |
| Rectal prolapse | Gastrointestinal disorders | MedDRA v 13.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA v 13.1 | Systematic Assessment |
| |
| Bile duct obstruction | Hepatobiliary disorders | MedDRA v 13.1 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA v 13.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA v 13.1 | Systematic Assessment |
| |
| Diabetic gangrene | Infections and infestations | MedDRA v 13.1 | Systematic Assessment |
| |
| Infected skin ulcer | Infections and infestations | MedDRA v 13.1 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA v 13.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v 13.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v 13.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA v 13.1 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA v 13.1 | Systematic Assessment |
| |
| Gastrointestinal stoma complication | Injury, poisoning and procedural complications | MedDRA v 13.1 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA v 13.1 | Systematic Assessment |
| |
| Multiple injuries | Injury, poisoning and procedural complications | MedDRA v 13.1 | Systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA v 13.1 | Systematic Assessment |
| |
| Neuropathic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA v 13.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v 13.1 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v 13.1 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA v 13.1 | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA v 13.1 | Systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA v 13.1 | Systematic Assessment |
| |
| Depression suicidal | Psychiatric disorders | MedDRA v 13.1 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA v 13.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA v 13.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v 13.1 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA v 13.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v 13.1 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA v 13.1 | Systematic Assessment |
| |
| Skin warm | Skin and subcutaneous tissue disorders | MedDRA v 13.1 | Systematic Assessment |
| |
| Deep-vein thrombosis | Vascular disorders | MedDRA v 13.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal Disorders | Gastrointestinal disorders | MedDRA v 13.1 | Systematic Assessment |
| |
| General disorders and administration site conditions | General disorders | MedDRA v 13.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA v 13.1 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA v 13.1 | Systematic Assessment |
| |
| Injury, poisoining and procedural complication | Injury, poisoning and procedural complications | MedDRA v 13.1 | Systematic Assessment |
| |
| Wound complication | Injury, poisoning and procedural complications | MedDRA v 13.1 | Systematic Assessment |
| |
| Infections and Infestations | Infections and infestations | MedDRA v 13.1 | Systematic Assessment |
| |
| Metabolism and Nutrition Disorders | Metabolism and nutrition disorders | MedDRA v 13.1 | Systematic Assessment |
| |
| Musculoskeletal and Connective Tissue Disorders | Musculoskeletal and connective tissue disorders | MedDRA v 13.1 | Systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA v 13.1 | Systematic Assessment |
| |
| Nervous System Disorders | Nervous system disorders | MedDRA v 13.1 | Systematic Assessment |
| |
| Skin and Subcutaneous Tissue Disorders | Skin and subcutaneous tissue disorders | MedDRA v 13.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v 13.1 | Systematic Assessment |
| |
| Skin Ulcer | Skin and subcutaneous tissue disorders | MedDRA v 13.1 | Systematic Assessment |
| |
| Venous Ulcer Pain | Skin and subcutaneous tissue disorders | MedDRA v 13.1 | Systematic Assessment |
| |
| Vascular Disorders | Vascular disorders | MedDRA v 13.1 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jaime E Dickerson, PhD | Smith & Nephew | 1-817-302-3914 | Jaime.Dickerson@smith-nephew.com |
| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| D014456 | Ulcer |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Withdrawal by Subject |
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| Site Closure |
|
| >=65 years |
|
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| United States |
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