1. Age 18 years or older 
2. Diagnosis of venous leg ulcer(s), as clinically determined by the investigator by a positive venous reflux test (venous refilling <20 seconds) using Doppler ultrasound for at least 4 weeks prior to screening day, which have not adequately responded to conventional ulcer therapy. 
3. Designated venous leg ulcer meets the following criteria at both the screening and baseline visits. If the patient has multiple ulcers, at least one ulcer must meet the following criteria at both the screening and baseline visits: 
1. Present for at least 4 weeks 
2. CEAP Classification Stage 6 
3. Surface ulcer with an area > 15cm2 post debridement 
4. Viable, granulating wound (investigator discretion) 
4. Ulcers that extend through the epidermis but not through the muscle, tendon, or bone (Stage II or III ulcers as defined by the IAET). 
5. Female patients of childbearing potential must have a negative pregnancy test at screening and must agree to use hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence throughout until 2 weeks after the last administration of study drug 
6. Signed informed consent 

NCT02652572_inc_T11
Value
18 years or older
NCT02652572_inc_T12
Person
Age
NCT02652572_inc_T13
Condition
venous leg ulcer(s)
NCT02652572_inc_T14
Measurement
venous reflux test
NCT02652572_inc_T15
Value
positive
NCT02652572_inc_T16
Measurement
venous refilling
NCT02652572_inc_T17
Value
<20 seconds
NCT02652572_inc_T18
Procedure
Doppler ultrasound
NCT02652572_inc_T19
Temporal
at least 4 weeks prior to screening day
NCT02652572_inc_T20
Reference_point
screening day
NCT02652572_inc_T21
Observation
responded
NCT02652572_inc_T22
Negation
not
NCT02652572_inc_T23
Qualifier
adequately
NCT02652572_inc_T24
Procedure
conventional ulcer therapy
NCT02652572_inc_T25
Condition
venous leg ulcer
NCT02652572_inc_T27
Condition
ulcers
NCT02652572_inc_T28
Multiplier
multiple
NCT02652572_inc_T29
Multiplier
at least one
NCT02652572_inc_T30
Condition
ulcer
NCT02652572_inc_T32
Temporal
at least 4 weeks
NCT02652572_inc_T33
Qualifier
Present
NCT02652572_inc_T34
Measurement
CEAP Classification
NCT02652572_inc_T35
Value
Stage 6
NCT02652572_inc_T36
Condition
Surface ulcer
NCT02652572_inc_T37
Value
> 15cm2
NCT02652572_inc_T38
Measurement
area post debridement
NCT02652572_inc_T39
Qualifier
Viable
NCT02652572_inc_T40
Qualifier
granulating
NCT02652572_inc_T41
Condition
wound
NCT02652572_inc_T43
Condition
Ulcers
NCT02652572_inc_T44
Qualifier
extend through the epidermis
NCT02652572_inc_T45
Qualifier
extend through the muscle
NCT02652572_inc_T46
Negation
not
NCT02652572_inc_T47
Value
Stage II or III
NCT02652572_inc_T48
Measurement
IAET
NCT02652572_inc_T49
Condition
ulcers
NCT02652572_inc_T50
Qualifier
extend through the tendon
NCT02652572_inc_T51
Qualifier
extend through the bone
NCT02652572_inc_T52
Scope
Ulcers that extend through the epidermis but not through the muscle, tendon, or bone
NCT02652572_inc_T53
Scope
extend through the epidermis but not through the muscle, tendon, or bone
NCT02652572_inc_T54
Condition
childbearing potential
NCT02652572_inc_T55
Measurement
pregnancy test
NCT02652572_inc_T56
Value
negative
NCT02652572_inc_T57
Temporal
at screening
NCT02652572_inc_T58
Reference_point
screening
NCT02652572_inc_T59
Drug
hormonal contraceptive
NCT02652572_inc_T60
Device
intrauterine device
NCT02652572_inc_T61
Device
diaphragm with spermicide
NCT02652572_inc_T62
Device
condom with spermicide
NCT02652572_inc_T63
Observation
abstinence
NCT02652572_inc_T64
Temporal
throughout until 2 weeks after the last administration of study drug
NCT02652572_inc_T65
Reference_point
last administration of study drug
NCT02652572_inc_T66
Person
Female
NCT02652572_inc_T67
Scope
Female patients of childbearing potential
NCT02652572_inc_T68
Scope
negative pregnancy test at screening and must agree to use hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence