1. Decrease in size of the designated target ulcer(s) by ≥ 30% during the 7-day screening period 
2. Cannot tolerate or comply with compression therapy. 
3. An ulcer which shows signs of severe clinical infection, defined as pus oozing from the ulcer site 
4. An ulcer positive for β-hemolytic streptococci upon culture 
5. The ulcer has > 50% slough, significant necrotic tissue, bone, tendon, or capsule exposure or avascular ulcer beds 
6. Is highly exuding (i.e. requires daily change of dressing) 
7. Ankle brachial pressure index <0.65 
8. Patients with active systemic infections 
9. Patients with clinically significant medical conditions as determined by the investigator including renal, hepatic, hematologic, neurologic or immune disease. Examples include but are not limited to: 
1. Renal insufficiency as an estimated GFR which is < 30 mL/min/1.7m2 
2. Abnormal blood biochemistry defined as 3 times that of the upper limit of the normal range. 
3. Hepatic insufficiency defined as total bilirubin > 2 mg/dL or serum albumin < 25 g/L 
4. HbA1c > 9% 
5. Hemoglobin < 10 g/dL 
6. Hematocrit < 0.30 
7. Platelet count < 100,000 
10. Presence of an active systemic or local cancer or tumor of any kind (with the exception of non-melanoma skin cancer) 
11. Patients with severe rheumatoid arthritis (with more than 20 persistently inflamed joints, or below lower normal limit blood albumin level, or evidence of bone and cartilage damage on x-ray, or inflammation in tissues other than joints) and other collagen vascular diseases. 
12. Patients with active connective tissue disease 
13. Treatment with systemic corticosteroids (>15 mg/day), or current immunosuppressive agents 
14. Previous or current radiation therapy or likelihood to receive this therapy during study participation 
15. Pregnant or nursing patients 
16. Known prior inability or unavailability to complete required study visits during study participation 
17. Significant peripheral edema as per investigator's discretion 
18. A psychiatric condition (e.g., suicidal ideation) or chronic alcohol or drug abuse problem, determined from the patient's medical history, which, in the opinion of the investigator, may pose a threat to patient compliance 
19. Use of a platelet-derived growth factor within 28 days before screening 
20. Use of any investigational drug or therapy within 28 days before screening 
21. Has any other factor which may, in the opinion of the investigator, compromise participation and/or follow-up in the study       
    

NCT02652572_exc_T29
Condition
target ulcer
NCT02652572_exc_T30
Qualifier
Decrease in size
NCT02652572_exc_T31
Value
≥ 30%
NCT02652572_exc_T32
Temporal
during the 7-day screening period
NCT02652572_exc_T33
Procedure
compression therapy
NCT02652572_exc_T36
Condition
pus
NCT02652572_exc_T37
Condition
ulcer
NCT02652572_exc_T38
Qualifier
shows signs of severe clinical infection
NCT02652572_exc_T40
Condition
severe clinical infection
NCT02652572_exc_T41
Condition
ulcer
NCT02652572_exc_T42
Qualifier
positive for β-hemolytic streptococci
NCT02652572_exc_T43
Measurement
slough
NCT02652572_exc_T44
Value
> 50%
NCT02652572_exc_T45
Condition
ulcer
NCT02652572_exc_T46
Observation
necrotic tissue
NCT02652572_exc_T47
Observation
bone exposure
NCT02652572_exc_T48
Observation
capsule exposure
NCT02652572_exc_T49
Observation
tendon exposure
NCT02652572_exc_T50
Observation
avascular ulcer beds
NCT02652572_exc_T51
Qualifier
highly exuding
NCT02652572_exc_T53
Multiplier
daily
NCT02652572_exc_T54
Procedure
change of dressing
NCT02652572_exc_T55
Measurement
Ankle brachial pressure index
NCT02652572_exc_T56
Value
<0.65
NCT02652572_exc_T57
Condition
systemic infections
NCT02652572_exc_T58
Temporal
active
NCT02652572_exc_T59
Condition
medical conditions
NCT02652572_exc_T60
Qualifier
clinically significant
NCT02652572_exc_T61
Observation
as determined by the investigator
NCT02652572_exc_T63
Condition
renal disease
NCT02652572_exc_T64
Condition
immune disease
NCT02652572_exc_T65
Condition
hepatic disease
NCT02652572_exc_T66
Condition
hematologic disease
NCT02652572_exc_T67
Condition
neurologic disease
NCT02652572_exc_T68
Scope
renal, hepatic, hematologic, neurologic or immune disease
NCT02652572_exc_T70
Condition
Renal insufficiency
NCT02652572_exc_T71
Measurement
estimated GFR
NCT02652572_exc_T72
Value
< 30 mL/min/1.7m2
NCT02652572_exc_T73
Measurement
blood biochemistry
NCT02652572_exc_T74
Value
3 times that of the upper limit of the normal range
NCT02652572_exc_T75
Value
Abnormal
NCT02652572_exc_T76
Condition
Hepatic insufficiency
NCT02652572_exc_T77
Measurement
total bilirubin
NCT02652572_exc_T78
Value
> 2 mg/dL
NCT02652572_exc_T79
Measurement
serum albumin
NCT02652572_exc_T80
Value
< 25 g/L
NCT02652572_exc_T81
Scope
total bilirubin > 2 mg/dL or serum albumin < 25 g/L
NCT02652572_exc_T82
Measurement
HbA1c
NCT02652572_exc_T83
Value
> 9%
NCT02652572_exc_T84
Measurement
Hemoglobin
NCT02652572_exc_T85
Value
< 10 g/dL
NCT02652572_exc_T86
Measurement
Hematocrit
NCT02652572_exc_T87
Value
< 0.30
NCT02652572_exc_T88
Measurement
Platelet count
NCT02652572_exc_T89
Value
< 100,000
NCT02652572_exc_T90
Condition
local cancer
NCT02652572_exc_T91
Condition
systemic cancer
NCT02652572_exc_T92
Temporal
active
NCT02652572_exc_T93
Condition
tumor of any kind
NCT02652572_exc_T94
Condition
non-melanoma skin cancer
NCT02652572_exc_T95
Negation
with the exception of
NCT02652572_exc_T96
Scope
systemic or local cancer or tumor of any kind
NCT02652572_exc_T97
Condition
rheumatoid arthritis
NCT02652572_exc_T98
Qualifier
severe
NCT02652572_exc_T99
Multiplier
more than 20
NCT02652572_exc_T101
Condition
inflamed joints
NCT02652572_exc_T102
Temporal
persistently
NCT02652572_exc_T100
Measurement
blood albumin level
NCT02652572_exc_T103
Value
below lower normal limit
NCT02652572_exc_T104
Condition
bone and cartilage damage
NCT02652572_exc_T105
Procedure
x-ray
NCT02652572_exc_T106
Condition
inflammation in tissues other than joints
NCT02652572_exc_T107
Condition
collagen vascular diseases
NCT02652572_exc_T108
Scope
more than 20 persistently inflamed joints, or below lower normal limit blood albumin level, or evidence of bone and cartilage damage on x-ray, or inflammation in tissues other than joints
NCT02652572_exc_T109
Condition
connective tissue disease
NCT02652572_exc_T110
Temporal
active
NCT02652572_exc_T111
Drug
systemic corticosteroids
NCT02652572_exc_T112
Value
>15 mg/day
NCT02652572_exc_T113
Procedure
Treatment
NCT02652572_exc_T114
Drug
immunosuppressive agents
NCT02652572_exc_T115
Temporal
current
NCT02652572_exc_T116
Procedure
radiation therapy
NCT02652572_exc_T119
Temporal
Previous
NCT02652572_exc_T120
Temporal
current
NCT02652572_exc_T121
Scope
Previous or current
NCT02652572_exc_T122
Condition
Pregnant
NCT02652572_exc_T123
Condition
nursing
NCT02652572_exc_T126
Condition
peripheral edema
NCT02652572_exc_T127
Qualifier
Significant
NCT02652572_exc_T130
Condition
psychiatric condition
NCT02652572_exc_T131
Condition
suicidal ideation
NCT02652572_exc_T132
Condition
alcohol abuse problem
NCT02652572_exc_T133
Condition
drug abuse problem
NCT02652572_exc_T136
Qualifier
may pose a threat to patient compliance
NCT02652572_exc_T137
Scope
psychiatric condition (e.g., suicidal ideation) or chronic alcohol or drug abuse problem
NCT02652572_exc_T138
Drug
platelet-derived growth factor
NCT02652572_exc_T139
Temporal
within 28 days before screening
NCT02652572_exc_T140
Reference_point
screening
NCT02652572_exc_T141
Drug
investigational drug
NCT02652572_exc_T142
Procedure
investigational therapy
NCT02652572_exc_T143
Temporal
within 28 days before screening
NCT02652572_exc_T144
Reference_point
screening