Safety and Efficacy Trial of HP802-247 in the Treatment o... | NCT01853384

ID	Type	Description	Link
2012-003286-18	EudraCT Number

Safety and Efficacy Trial of HP802-247 in the Treatment o... | NCT01853384 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HP802-247 plus compression therapy	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 10(6th) cells per mL every 14 days. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks.	Biological: HP802-247
HP802-247 Vehicle plus compression therapy	Placebo Comparator	fibrinogen solution & thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly.	Other: HP802-247 Vehicle

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HP802-247	Biological	Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days.	HP802-247 plus compression therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Compare the Treatment Groups for the Number 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 prior to the end of treatment, their remaining visit values were imputed using LOCF; wound status of closed was not imputed.	Weekly, over 12 Weeks or until wound closure, which ever occurred first

Secondary Outcomes

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.	12 Weeks
Compare the Efficacy of the Treatment Groups in Achieving Complete Wound Closure, Based on Median Time (Days) to Closure Over the 12-Week Treatment Period From Baseline.

Eligibility Module

Contacts/Locations Module

Overall Officials

Name	Affiliation	Role
Herbert B. Slade, MD	Smith & Nephew, Inc.	Study Chair
Tommy Lee, MSHS	Smith & Nephew, Inc.	Study Director
Wolfgang Vanscheidt, Professor Dr	University Freiburg-Practice for Dermatology	Principal Investigator

References Module

Citations

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.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	HP802-247 Plus Compression Therapy	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 10(6th) cells per mL every 14 days for up to 12 weeks or wound closure, which ever occurred first. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks. HP802-247: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Comment	Reasons
Adverse Event		FG0005 subjects FG0013 subjects
Death		FG0001 subjects FG0012 subjects
Lost to Follow-up		FG0001 subjects FG0011 subjects
Withdrawal by Subject		FG0005 subjects FG0013 subjects
Sponsor Decision		FG00047 subjects FG00134 subjects
Other		FG0003 subjects FG0013 subjects

Enrolled in Follow up Period

Type	Comment	Milestone Data
STARTED		FG00096 subjects FG00194 subjects
Not Enrolled in Follow-up		FG00035 subjects FG00127 subjects
COMPLETED		FG00096 subjects FG00194 subjects
NOT COMPLETED		FG0000 subjects FG0010 subjects

Completed Follow up Visit 1

Type	Comment	Milestone Data
STARTED		FG00096 subjects FG00194 subjects
COMPLETED		FG00082 subjects FG00185 subjects
NOT COMPLETED		FG00014 subjects FG0019 subjects

Type	Comment	Reasons
Early Termination		FG00013 subjects FG0019 subjects
Withdrawal by Subject		FG0001 subjects FG001

Completed Follow up Visit 2

Type	Comment	Milestone Data
STARTED		FG00096 subjects FG00194 subjects
COMPLETED		FG00093 subjects FG00191 subjects
NOT COMPLETED		FG0003 subjects FG0013 subjects

Type	Comment	Reasons
Adverse Event		FG0001 subjects FG0010 subjects
Withdrawal by Subject		FG0001 subjects FG001

Arm/Group Information

ID	Title	Description
BG000	HP802-247 Plus Compression Therapy	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 10(6th) cells per mL every 14 days for up to 12 weeks or wound closure, which ever occurred first. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks. HP802-247: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days.
BG001	HP802-247 Vehicle Plus Compression Therapy	fibrinogen solution & thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly for up to 12 weeks or wound closure, which ever occurred first. HP802-247 Vehicle: HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Full Range

years

Title

Denominators

Categories

Title	Measurements
	BG00065.6(28 to 90) BG00168.1(28 to 92) BG00266.8(28 to 92)

Age, Customized

Number

participants

Title

Denominators

Categories

18-39 years

Title	Measurements
	BG0006 BG0013 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00076 BG00163 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0001 BG0010 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

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 Number 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 prior to the end of treatment, 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.

Posted

Number

participants

Weekly, over 12 Weeks or until wound closure, which ever occurred first

ID	Title	Description
OG000	HP802-247 Plus Compression Therapy	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 10(6th) cells per mL every 14 days for up to 12 weeks or wound closure, which ever occurred first. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks. HP802-247: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days.
OG001	HP802-247 Vehicle Plus Compression Therapy	fibrinogen solution & thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly for up to 12 weeks or wound closure, which ever occurred first. HP802-247 Vehicle: HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface.

Units	Counts
Participants	OG000131 OG001121

Title

Denominators

Categories

Wounds Closed

Title	Measurements
	OG00061 OG00161

Wounds Not Closed

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Cochran-Mantel-Haenszel		.5348	Analysis adjusted for sites, with significance being at P < 0.05												No	Superiority or Other

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.

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.

Posted

Median

Full Range

days

12 Weeks

ID	Title	Description
OG000	HP802-247 Plus Compression Therapy	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 10(6th) cells per mL every 14 days for up to 12 weeks or wound closure, which ever occurred first. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks. HP802-247: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days.
OG001	HP802-247 Vehicle Plus Compression Therapy	fibrinogen solution & thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly for up to 12 weeks or wound closure, which ever occurred first. HP802-247 Vehicle: HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface.

Secondary

Compare the Efficacy of the Treatment Groups in Achieving Complete Wound Closure, Based on Median Time (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 Kaplan-Meier Survival analysis, with significance being at P < 0.05.

Posted

Median

95% Confidence Interval

days

12 weeks

ID	Title	Description
OG000	HP802-247 Plus Compression Therapy	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 10(6th) cells per mL every 14 days for up to 12 weeks or wound closure, which ever occurred first. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks. HP802-247: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days.
OG001	HP802-247 Vehicle Plus Compression Therapy	fibrinogen solution & thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly for up to 12 weeks or wound closure, which ever occurred first. HP802-247 Vehicle: HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface.

Secondary

Compare the Treatment Groups for the Proportion of Subjects With Wound Closure at Each of the 12-Week Treatment Period From Baseline

For subjects who dropped from the study, their remaining visit values were imputed using LOCF. Treatment groups were compared for percentage of participants with closed wounds at each treatment visit.

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 participants

Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first

ID	Title	Description
OG000	HP802-247 Plus Compression Therapy	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 10(6th) cells per mL every 14 days for up to 12 weeks or wound closure, which ever occurred first. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks. HP802-247: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days.
OG001	HP802-247 Vehicle Plus Compression Therapy	fibrinogen solution & thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly for up to 12 weeks or wound closure, which ever occurred first. HP802-247 Vehicle: HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface.

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.

Due to study termination the data available to assess durability of closure were limited to only the subjects who completed at least one of the follow-up visits. Participants who had CLOSED wounds at completion of treatment; 103 subjects (HP802-247: 49; Vehicle: 54) completed Visit 18, 114 subjects (HP802-247: 57; Vehicle: 57) completed Visit 19

Posted

Number

participants

Target ulcer status observed at two (visit 1) and three (visit 2) months following initial ulcer closure.

ID	Title	Description
OG000	HP802-247 Plus Compression Therapy	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 10(6th) cells per mL every 14 days for up to 12 weeks or wound closure, which ever occurred first. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks. HP802-247: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days.
OG001	HP802-247 Vehicle Plus Compression Therapy

Secondary

Change From Baseline in Pain Associated With the Target Wound at Each of the 12 Double Blind Treatment Weeks

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.

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

Baseline and Weekly, over the 12 week treatment period

ID	Title	Description
OG000	HP802-247 Plus Compression Therapy	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 10(6th) cells per mL every 14 days for up to 12 weeks or wound closure, which ever occurred first. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks. HP802-247: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days.
OG001	HP802-247 Vehicle Plus Compression Therapy	fibrinogen solution & thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly for up to 12 weeks or wound closure, which ever occurred first. HP802-247 Vehicle: HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface.

Secondary

Change From Baseline 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

Baseline and Weekly, over the 12 week treatment period

ID	Title	Description
OG000	HP802-247 Plus Compression Therapy	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 10(6th) cells per mL every 14 days for up to 12 weeks or wound closure, which ever occurred first. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks. HP802-247: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days.
OG001	HP802-247 Vehicle Plus Compression Therapy	fibrinogen solution & thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly for up to 12 weeks or wound closure, which ever occurred first. HP802-247 Vehicle: HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface.

Arm/Groups

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 Plus Compression Therapy	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 10(6th) cells per mL every 14 days for up to 12 weeks or wound closure, which ever occurred first. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks. HP802-247: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days.			5	131	60	131
EG001	HP802-247 Vehicle Plus Compression Therapy	fibrinogen solution & thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly for up to 12 weeks or wound closure, which ever occurred first. HP802-247 Vehicle: HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface.			12	121	64	121

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angina pectoris	Cardiac disorders	MedDRA v 13.1	Systematic Assessment	EG0000 events0 affected131 at risk EG0011 events1 affected121 at risk
Arrhythmia	Cardiac disorders	MedDRA v 13.1	Systematic Assessment	EG0001 events1 affected131 at risk EG0010 events0 affected121 at risk
Cardiac arrest	Cardiac disorders	MedDRA v 13.1	Systematic Assessment	EG0001 events1 affected131 at risk EG0010 events0 affected121 at risk
Cardiac failure	Cardiac disorders	MedDRA v 13.1	Systematic Assessment	EG0000 events0 affected131 at risk EG0011 events1 affected121 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA v 13.1	Systematic Assessment	EG0000 events0 affected131 at risk EG0011 events1 affected121 at risk
Oedema peripheral	General disorders	MedDRA v 13.1	Systematic Assessment	EG0000 events0 affected131 at risk EG0012 events1 affected121 at risk
Erysipelas	Infections and infestations	MedDRA v 13.1	Systematic Assessment	EG0000 events0 affected131 at risk EG0011 events1 affected121 at risk
Gangrene	Infections and infestations	MedDRA v 13.1	Systematic Assessment	EG0001 events1 affected131 at risk EG0010 events0 affected121 at risk
Pneumonia	Infections and infestations	MedDRA v 13.1	Systematic Assessment	EG0000 events0 affected131 at risk EG0011 events1 affected121 at risk
Wound sepsis	Infections and infestations	MedDRA v 13.1	Systematic Assessment	EG0000 events0 affected131 at risk EG0011 events1 affected121 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA v 13.1	Systematic Assessment	EG0001 events1 affected131 at risk EG0010 events0 affected121 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA v 13.1	Systematic Assessment	EG0001 events1 affected131 at risk EG0010 events0 affected121 at risk
Multiple injuries	Injury, poisoning and procedural complications	MedDRA v 13.1	Systematic Assessment	EG0000 events0 affected131 at risk EG0012 events2 affected121 at risk
Traumatic haematoma	Injury, poisoning and procedural complications	MedDRA v 13.1	Systematic Assessment	EG0000 events0 affected131 at risk EG0011 events1 affected121 at risk
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 13.1	Systematic Assessment	EG0001 events1 affected131 at risk EG0010 events0 affected121 at risk
Vulval cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 13.1	Systematic Assessment	EG0001 events1 affected131 at risk EG0010 events0 affected121 at risk
Metrorrhagia	Reproductive system and breast disorders	MedDRA v 13.1	Systematic Assessment	EG0000 events0 affected131 at risk EG0011 events1 affected121 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA v 13.1	Systematic Assessment	EG0000 events0 affected131 at risk EG0011 events1 affected121 at risk
Pemphigoid	Skin and subcutaneous tissue disorders	MedDRA v 13.1	Systematic Assessment	EG0000 events0 affected131 at risk EG0011 events1 affected121 at risk
Purpura	Skin and subcutaneous tissue disorders	MedDRA v 13.1	Systematic Assessment	EG0000 events0 affected131 at risk EG0011 events1 affected121 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA v 13.1	Systematic Assessment	EG0001 events1 affected131 at risk EG0010 events0 affected121 at risk
Stasis dermatitis	Skin and subcutaneous tissue disorders	MedDRA v 13.1	Systematic Assessment	EG0000 events0 affected131 at risk EG0011 events1 affected121 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Gastrointestinal disorders	Gastrointestinal disorders	MedDRA v 13.1	Systematic Assessment	EG0009 events5 affected131 at risk EG0018 events6 affected121 at risk
General disorders and administration site conditions	General disorders	MedDRA v 13.1	Systematic Assessment	EG0003 events3 affected131 at risk EG00111 events9 affected121 at risk
Infections and infestations	Infections and infestations	MedDRA v 13.1	Systematic Assessment	EG00020 events15 affected131 at risk EG00123 events19 affected121 at risk
Infected skin ulcer	Infections and infestations	MedDRA v 13.1	Systematic Assessment	EG0009 events7 affected131 at risk EG0017 events5 affected121 at risk
Injury, poisoning and procedural complications	Injury, poisoning and procedural complications	MedDRA v 13.1	Systematic Assessment	EG00022 events18 affected131 at risk EG00113 events13 affected121 at risk
Excoriation	Injury, poisoning and procedural complications	MedDRA v 13.1	Systematic Assessment	EG00012 events10 affected131 at risk EG0016 events6 affected121 at risk
Metabolism and nutrition disorders	Metabolism and nutrition disorders	MedDRA v 13.1	Systematic Assessment	EG0002 events2 affected131 at risk EG0014 events4 affected121 at risk
Musculoskeletal and connective tissue disorders	Musculoskeletal and connective tissue disorders	MedDRA v 13.1	Systematic Assessment	EG00013 events9 affected131 at risk EG00119 events14 affected121 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA v 13.1	Systematic Assessment	EG0006 events5 affected131 at risk EG00115 events12 affected121 at risk
Nervous system disorders	Nervous system disorders	MedDRA v 13.1	Systematic Assessment	EG0007 events2 affected131 at risk EG0014 events4 affected121 at risk
Skin and subcutaneous tissue disorders	Skin and subcutaneous tissue disorders	MedDRA v 13.1	Systematic Assessment	EG00062 events30 affected131 at risk EG00187 events39 affected121 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA v 13.1	Systematic Assessment	EG0006 events4 affected131 at risk EG0012 events1 affected121 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA v 13.1	Systematic Assessment	EG0004 events4 affected131 at risk EG0016 events5 affected121 at risk
Skin maceration	Skin and subcutaneous tissue disorders	MedDRA v 13.1	Systematic Assessment	EG0003 events2 affected131 at risk EG00113 events7 affected121 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA v 13.1	Systematic Assessment	EG00034 events17 affected131 at risk EG00137 events20 affected121 at risk
Venous ulcer pain	Skin and subcutaneous tissue disorders	MedDRA v 13.1	Systematic Assessment	EG0006 events6 affected131 at risk EG0013 events3 affected121 at risk
Vascular disorders	Vascular disorders	MedDRA v 13.1	Systematic Assessment	EG0008 events5 affected131 at risk EG00111 events10 affected121 at risk
Hypertension	Vascular disorders	MedDRA v 13.1	Systematic Assessment	EG0008 events5 affected131 at risk EG0018 events7 affected121 at risk

Ancestor Terms

ID	Term
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
D013927	Thrombosis
D016769	Embolism and Thrombosis

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Regression, Cox		.9456													No	Superiority or Other

Title

Denominators

Categories

Baseline

Title	Measurements
	OG0000 OG0010

Treatment Week 01

Title	Measurements
	OG0002.3 OG0013.3

Treatment Week 02

Title	Measurements
	OG0008.4 OG0017.4

Treatment Week 03

Title	Measurements
	OG00013.7 OG00118.2

Treatment Week 04

Title	Measurements
	OG00022.1 OG00125.6

Treatment Week 05

Title	Measurements
	OG00026.7 OG00133.9

Treatment Week 06

Title	Measurements
	OG00029.8 OG00138.0

Treatment Week 07

Title	Measurements
	OG00032.8 OG00139.7

Treatment Week 08

Title	Measurements
	OG00037.4 OG00139.7

Treatment Week 09

Title	Measurements
	OG00038.9 OG00143.8

Treatment Week 10

Title	Measurements
	OG00040.5 OG00146.3

Treatment Week 11

Title	Measurements
	OG00041.2 OG00147.9

Treatment Week 12

Title	Measurements
	OG00048.1 OG00153.7

Week 12 - Primary Endpoint

Title	Measurements
	OG00046.6 OG00150.4

Group IDs	Statistical Method	P-Value	P-Value Comment	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG001	Cochran-Mantel-Haenszel	.6194	Treatment Week 01	No	Superiority or Other
OG000 OG001	Cochran-Mantel-Haenszel	.7930	Treatment Week 02	No	Superiority or Other
OG000 OG001	Cochran-Mantel-Haenszel	0.3362	Treatment Week 03	No	Superiority or Other
OG000 OG001	Cochran-Mantel-Haenszel	0.5263	Treatment Week 04	No	Superiority or Other
OG000 OG001	Cochran-Mantel-Haenszel	0.1997	Treatment Week 05	No	Superiority or Other
OG000 OG001	Cochran-Mantel-Haenszel	0.1617	Treatment Week 06	No	Superiority or Other
OG000 OG001	Cochran-Mantel-Haenszel	0.2611	Treatment Week 07	No	Superiority or Other
OG000 OG001	Cochran-Mantel-Haenszel	0.7232	Treatment Week 08	No	Superiority or Other
OG000 OG001	Cochran-Mantel-Haenszel	0.4405	Treatment Week 09	No	Superiority or Other
OG000 OG001	Cochran-Mantel-Haenszel	0.3516	Treatment Week 10	No	Superiority or Other
OG000 OG001	Cochran-Mantel-Haenszel	0.2821	Treatment Week 11	No	Superiority or Other
OG000 OG001	Cochran-Mantel-Haenszel	0.3722	Treatment Week 12	No	Superiority or Other
OG000 OG001	Cochran-Mantel-Haenszel	0.5348	Week 12 - Primary Endpoint	No	Superiority or Other

Title

Denominators

Categories

Follow-up Visit 1 (wounds remained closed)

Title	Measurements
	OG00045 OG00152

Follow-up Visit 1 (wounds reopened)

Title	Measurements
	OG0004 OG0012

Follow-up Visit 2 (wounds remained closed)

Title	Measurements
	OG00051 OG00147

Follow-up Visit 2 (wounds reopened)

Title	Measurements
	OG0006 OG00110

Title

Denominators

Categories

Baseline

Title	Measurements
	OG00029.40± 28.5 OG00126.30± 28.3

Week 01

Title	Measurements
	OG000-8.6± 2 OG001-7.5± 2.1

Week 02

Title	Measurements
	OG000-10.4± 2.2 OG001-11.0± 2.3

Week 03

Title	Measurements
	OG000-14.0± 2.3 OG001-10.7± 2.4

Week 04

Title	Measurements
	OG000-14.3± 2.3 OG001-12.1± 2.3

Week 05

Title	Measurements
	OG000-17.2± 2.1 OG001-13.6± 2.2

Week 06

Title	Measurements
	OG000-17.8± 2.2 OG001-15.4± 2.2

Week 07

Title	Measurements
	OG000-18.5± 2.0 OG001-17.5± 2.1

Week 08

Title	Measurements
	OG000-20.0± 2.0 OG001-17.1± 2.1

Week 09

Title	Measurements
	OG000-19.7± 2.1 OG001-17.9± 2.1

Week 10

Title	Measurements
	OG000-18.9± 2.0 OG001-18.4± 2.1

Week 11

Title	Measurements
	OG000-19.4± 2.0 OG001-19.7± 2.1

Week 12

Title	Measurements
	OG000-20.0± 2.0 OG001-20.1± 2.0

Group IDs	Statistical Method	P-Value	P-Value Comment	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG001	ANCOVA	0.5909	Week 01	No	Superiority or Other
OG000 OG001	ANCOVA	0.8234	Week 02	No	Superiority or Other
OG000 OG001	ANCOVA	0.1556	Week 03	No	Superiority or Other
OG000 OG001	ANCOVA	0.3487	Week 04	No	Superiority or Other
OG000 OG001	ANCOVA	0.1064	Week 05	No	Superiority or Other
OG000 OG001	ANCOVA	0.2888	Week 06	No	Superiority or Other
OG000 OG001	ANCOVA	0.6095	Week 07	No	Superiority or Other
OG000 OG001	ANCOVA	0.1566	Week 08	No	Superiority or Other
OG000 OG001	ANCOVA	0.4216	Week 09	No	Superiority or Other
OG000 OG001	ANCOVA	0.8166	Week10	No	Superiority or Other
OG000 OG001	ANCOVA	0.9114	Week 11	No	Superiority or Other
OG000 OG001	ANCOVA	0.9733	Week 12	No	Superiority or Other

Title

Denominators

Categories

Baseline

Title	Measurements
	OG00024.18± 27.0 OG00122.35± 16.0

Week 01

Title	Measurements
	OG000-4.1± 2.3 OG001-4.9± 2.4

Week 02

Title	Measurements
	OG000-2.2± 2.3 OG001-1.3± 2.4

Week 03

Title	Measurements
	OG000-9.2± 2.2 OG001-5.3± 2.3

Week 04

Title	Measurements
	OG000-10.1± 2.2 OG001-8.8± 2.2

Week 05

Title	Measurements
	OG000-9.7± 2.3 OG001-8.6± 2.3

Week 06

Title	Measurements
	OG000-12.2± 2.0 OG001-9.1± 2.1

Week 07

Title	Measurements
	OG000-13.1± 2.2 OG001-8.9± 2.2

Week 08

Title	Measurements
	OG000-14.2± 2.1 OG001-9.0± 2.1

Week 09

Title	Measurements
	OG000-10.1± 2.2 OG001-6.3± 2.3

Week 10

Title	Measurements
	OG000-12.7± 2.1 OG001-11.1± 2.2

Week 11

Title	Measurements
	OG000-12.9± 2.0 OG001-11.8± 2.1

Week 12

Title	Measurements
	OG000-14.3± 2.0 OG001-12.2± 2.1

Group IDs	Statistical Method	P-Value	P-Value Comment	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG001	ANCOVA	0.7439	Week 01	No	Superiority or Other
OG000 OG001	ANCOVA	0.6992	Week 02	No	Superiority or Other
OG000 OG001	ANCOVA	0.0867	Week 03	No	Superiority or Other
OG000 OG001	ANCOVA	0.5739	Week 04	No	Superiority or Other
OG000 OG001	ANCOVA	0.6497	Week 05	No	Superiority or Other
OG000 OG001	ANCOVA	0.1427	Week 06	No	Superiority or Other
OG000 OG001	ANCOVA	0.0682	Week 07	No	Superiority or Other
OG000 OG001	ANCOVA	0.0161	Week 08	No	Superiority or Other
OG000 OG001	ANCOVA	0.0973	Week 09	No	Superiority or Other
OG000 OG001	ANCOVA	0.4661	Week 10	No	Superiority or Other
OG000 OG001	ANCOVA	0.6010	Week 11	No	Superiority or Other
OG000 OG001	ANCOVA	0.3369	Week 12	No	Superiority or Other

Facility	Status	City	State	ZIP	Country	Contacts
		Anderlecht			Belgium

ID	Term
D014647	Varicose Ulcer
D014456	Ulcer
D014947	Wounds and Injuries
D014648	Varicose Veins
D014689	Venous Insufficiency
D020246	Venous Thrombosis