A Case Series Evaluating a Fibrillar Collagen Powder Dressing to Treat Chronic, Stalled Lower-extremity Wounds
Phase: NA
Conditions: Wound
Sponsor: Medline Industries

M e dli n e I n d u stri e s, I n c. 
 
 
Fi brill ar dr e s si n g f or tr e ati n g c hr o ni c, st all e d w o u n d s  
M E D- 2 0 1 8- DI V 7 1- 0 0 8 
 
C O N FI D E N TI A L                        
2 3 A u g u st 2 0 1 8 
V 1 . 0 
 
           
1 
 
A case series e val uati n g a fi brillar c olla ge n p o w der dressi n g t o treat c hr o nic, 
stalle d l o wer-e xtre mit y w o u n ds 
 
 
Pr ot oc ol N u m ber M E D - 2 0 1 8- DI V 7 1- 0 0 8 
 
 
 
2 3  A u g ust 2 0 1 8 
Versi o n 1 . 0 
 
 
 
 
 
 
Pre pare d b y: 
 
Me dli ne I n d ustries 
T hree La kes Dri ve 
N ort hfiel d, I L 6 0 0 9 3  
 
 
 
 
 
 
 
 
 
 
 
Pr e p ar e d b y ( Si g n at ur e)  
 
D at e  
R e vi e w e d b y ( Si g n at ur e)  
 
D at e  
M e dli n e I n d u stri e s, I n c.  
T hr e e L a k e s Dri v e  
N ort hfi el d, I L 6 0 0 9 3  
 
 
 
J a  m es   M   M o nti
Di git all y si g n e d  b y J a  m es   M   M o nti 
D  N:  c n =J a  m es   M   M o nti,  o =  M e dli n e 
I n d ustri es,  o u = Cli ni c al  R &  D, 
e  m ail =j  m o nti  @  m e dli n e. c o  m,  c = U S 
D at e:  2 0 1 8. 0 8. 2 4  0 9: 2 8: 3 2 - 0 5' 0 0'
Willi a  m J a c o bs o n
Di git all y si g n e d  b y   Willi a  m J a c o bs o n 
D  N:  c n =  Willi a  m J a c o bs o n,  o =  Dir e ct or,  C Li ni c al 
Aff airs,  o u =  M e dli n e   M e di c al  Aff airs, 
e  m ail =  wij a c o bs o n  @  m e dli n e. c o  m,  c = U S 
D at e:  2 0 1 8. 0 8. 2 4  0 9: 3 5: 4 1 - 0 5' 0 0'
J a  m es   M   M o nti
Di git all y si g n e d  b y J a  m es   M   M o nti 
D  N:  c n =J a  m es   M   M o nti,  o =  M e dli n e 
I n d ustri es,  o u = Cli ni c al  R &  D, 
e  m ail =j  m o nti  @  m e dli n e. c o  m,  c = U S 
D at e:  2 0 1 8. 0 8. 2 4  0 9: 2 8: 3 2 - 0 5' 0 0'
Willi a  m J a c o bs o n
Di git all y si g n e d  b y   Willi a  m J a c o bs o n 
D  N:  c n =  Willi a  m J a c o bs o n,  o =  Dir e ct or,  C Li ni c al 
Aff airs,  o u =  M e dli n e   M e di c al  Aff airs, 
e  m ail =  wij a c o bs o n  @  m e dli n e. c o  m,  c = U S 
D at e:  2 0 1 8. 0 8. 2 4  0 9: 3 5: 4 1 - 0 5' 0 0'
J a  m es   M   M o nti
Di git all y si g n e d  b y J a  m es   M   M o nti 
D  N:  c n =J a  m es   M   M o nti,  o =  M e dli n e 
I n d ustri es,  o u = Cli ni c al  R &  D, 
e  m ail =j  m o nti  @  m e dli n e. c o  m,  c = U S 
D at e:  2 0 1 8. 0 8. 2 4  0 9: 2 8: 3 2 - 0 5' 0 0'
Willi a  m J a c o bs o n
Di git all y si g n e d  b y   Willi a  m J a c o bs o n 
D  N:  c n =  Willi a  m J a c o bs o n,  o =  Dir e ct or,  C Li ni c al 
Aff airs,  o u =  M e dli n e   M e di c al  Aff airs, 
e  m ail =  wij a c o bs o n  @  m e dli n e. c o  m,  c = U S 
D at e:  2 0 1 8. 0 8. 2 4  0 9: 3 5: 4 1 - 0 5' 0 0'
J a  m es   M   M o nti
Di git all y si g n e d  b y J a  m es   M   M o nti 
D  N:  c n =J a  m es   M   M o nti,  o =  M e dli n e 
I n d ustri es,  o u = Cli ni c al  R &  D, 
e  m ail =j  m o nti  @  m e dli n e. c o  m,  c = U S 
D at e:  2 0 1 8. 0 8. 2 4  0 9: 2 8: 3 2 - 0 5' 0 0'
Willi a  m J a c o bs o n
Di git all y si g n e d  b y   Willi a  m J a c o bs o n 
D  N:  c n =  Willi a  m J a c o bs o n,  o =  Dir e ct or,  C Li ni c al 
Aff airs,  o u =  M e dli n e   M e di c al  Aff airs, 
e  m ail =  wij a c o bs o n  @  m e dli n e. c o  m,  c = U S 
D at e:  2 0 1 8. 0 8. 2 4  0 9: 3 5: 4 1 - 0 5' 0 0'
J a  m es   M   M o nti
Di git all y si g n e d  b y J a  m es   M   M o nti 
D  N:  c n =J a  m es   M   M o nti,  o =  M e dli n e 
I n d ustri es,  o u = Cli ni c al  R &  D, 
e  m ail =j  m o nti  @  m e dli n e. c o  m,  c = U S 
D at e:  2 0 1 8. 0 8. 2 4  0 9: 2 8: 3 2 - 0 5' 0 0'
Willi a  m J a c o bs o n
Di git all y si g n e d  b y   Willi a  m J a c o bs o n 
D  N:  c n =  Willi a  m J a c o bs o n,  o =  Dir e ct or,  C Li ni c al 
Aff airs,  o u =  M e dli n e   M e di c al  Aff airs, 
e  m ail =  wij a c o bs o n  @  m e dli n e. c o  m,  c = U S 
D at e:  2 0 1 8. 0 8. 2 4  0 9: 3 5: 4 1 - 0 5' 0 0'
J a  m es   M   M o nti
Di git all y si g n e d  b y J a  m es   M   M o nti 
D  N:  c n =J a  m es   M   M o nti,  o =  M e dli n e 
I n d ustri es,  o u = Cli ni c al  R &  D, 
e  m ail =j  m o nti  @  m e dli n e. c o  m,  c = U S 
D at e:  2 0 1 8. 0 8. 2 4  0 9: 2 8: 3 2 - 0 5' 0 0'
Willi a  m J a c o bs o n
Di git all y si g n e d  b y   Willi a  m J a c o bs o n 
D  N:  c n =  Willi a  m J a c o bs o n,  o =  Dir e ct or,  C Li ni c al 
Aff airs,  o u =  M e dli n e   M e di c al  Aff airs, 
e  m ail =  wij a c o bs o n  @  m e dli n e. c o  m,  c = U S 
D at e:  2 0 1 8. 0 8. 2 4  0 9: 3 5: 4 1 - 0 5' 0 0'
J a  m es   M   M o nti
Di git all y si g n e d  b y J a  m es   M   M o nti 
D  N:  c n =J a  m es   M   M o nti,  o =  M e dli n e 
I n d ustri es,  o u = Cli ni c al  R &  D, 
e  m ail =j  m o nti  @  m e dli n e. c o  m,  c = U S 
D at e:  2 0 1 8. 0 8. 2 4  0 9: 2 8: 3 2 - 0 5' 0 0'
Willi a  m J a c o bs o n
Di git all y si g n e d  b y   Willi a  m J a c o bs o n 
D  N:  c n =  Willi a  m J a c o bs o n,  o =  Dir e ct or,  C Li ni c al 
Aff airs,  o u =  M e dli n e   M e di c al  Aff airs, 
e  m ail =  wij a c o bs o n  @  m e dli n e. c o  m,  c = U S 
D at e:  2 0 1 8. 0 8. 2 4  0 9: 3 5: 4 1 - 0 5' 0 0'
J a  m es   M   M o nti
Di git all y si g n e d  b y J a  m es   M   M o nti 
D  N:  c n =J a  m es   M   M o nti,  o =  M e dli n e 
I n d ustri es,  o u = Cli ni c al  R &  D, 
e  m ail =j  m o nti  @  m e dli n e. c o  m,  c = U S 
D at e:  2 0 1 8. 0 8. 2 4  0 9: 2 8: 3 2 - 0 5' 0 0'
Willi a  m J a c o bs o n
Di git all y si g n e d  b y   Willi a  m J a c o bs o n 
D  N:  c n =  Willi a  m J a c o bs o n,  o =  Dir e ct or,  C Li ni c al 
Aff airs,  o u =  M e dli n e   M e di c al  Aff airs, 
e  m ail =  wij a c o bs o n  @  m e dli n e. c o  m,  c = U S 
D at e:  2 0 1 8. 0 8. 2 4  0 9: 3 5: 4 1 - 0 5' 0 0'
J a  m es   M   M o nti
Di git all y si g n e d  b y J a  m es   M   M o nti 
D  N:  c n =J a  m es   M   M o nti,  o =  M e dli n e 
I n d ustri es,  o u = Cli ni c al  R &  D, 
e  m ail =j  m o nti  @  m e dli n e. c o  m,  c = U S 
D at e:  2 0 1 8. 0 8. 2 4  0 9: 2 8: 3 2 - 0 5' 0 0'
Willi a  m J a c o bs o n
Di git all y si g n e d  b y   Willi a  m J a c o bs o n 
D  N:  c n =  Willi a  m J a c o bs o n,  o =  Dir e ct or,  C Li ni c al 
Aff airs,  o u =  M e dli n e   M e di c al  Aff airs, 
e  m ail =  wij a c o bs o n  @  m e dli n e. c o  m,  c = U S 
D at e:  2 0 1 8. 0 8. 2 4  0 9: 3 5: 4 1 - 0 5' 0 0'
J a m es  M  M o nti
Di git all y si g n e d  b y J a m es  M  M o nti 
D N:  c n =J a m es  M  M o nti,  o = M e dli n e 
I n d ustri es,  o u = Cli ni c al  R & D, 
e m ail =j m o nti @ m e dli n e. c o m,  c = U S 
D at e:  2 0 1 8. 0 8. 2 4  0 9: 2 8: 3 2 - 0 5' 0 0'
Willi a m J a c o bs o n
Di git all y si g n e d  b y  Willi a m J a c o bs o n 
D N:  c n = Willi a m J a c o bs o n,  o = Dir e ct or,  C Li ni c al 
Aff airs,  o u = M e dli n e  M e di c al  Aff airs, 
e m ail = wij a c o bs o n @ m e dli n e. c o m,  c = U S 
D at e:  2 0 1 8. 0 8. 2 4  0 9: 3 5: 4 1 - 0 5' 0 0'
J a m es M M o nti
Di git all y si g n e d b y J a m es M M o nti 
D N: c n =J a m es M M o nti, o = M e dli n e 
I n d ustri es, o u = Cli nic al R & D, 
e m ail =j m o nti @ m e dli n e.c o m, c = U S 
D at e: 2 0 1 8. 0 8. 2 4 0 9: 2 8: 3 2 - 0 5' 0 0'
Willi a m J ac o bs o n
Di git all y si g n e d b y Willi a m J ac o bs o n 
D N: c n = Willi a m J ac o bs o n, o = Dir ect or, C Li nic al 
Aff airs, o u = M e dli n e M e dic al Aff airs, 
e m ail = wij ac o bs o n @ m e dli n e.c o m, c = U S 
D at e: 2 0 1 8. 0 8. 2 4 0 9: 3 5: 4 1 - 0 5' 0 0'

M e dli n e I n d u stri e s, I n c. 
 
 
Fi brill ar dr e s si n g f or tr e ati n g c hr o ni c, st all e d w o u n d s  
M E D- 2 0 1 8- DI V 7 1- 0 0 8 
 
C O N FI D E N TI A L                        
2 3 A u g u st 2 0 1 8 
V 1 . 0 
 
           
2 
 
C o nt e nts 
I N V E S TI G A T O R A C K N O W L E D G M E N T SI G N A T U R E ................................................................................ 4 
1.  
P R O T O C O L S U M M A R Y ....................................................................................................................... 6 
1. 1.  
S Y N O P SI S .................................................................................................................................... 6 
1. 2.  
S C H E D U L E O F A C TI VI TI E S ( S O A) ............................................................................................. 8 
2.  
I N T R O D U C TI O N ................................................................................................................................... 9 
2. 1.  
B A C K G R O U N D & R A TI O N A L E .................................................................................................... 9 
2. 2.  
I N V E S TI G A TI O N A L P R O D U C T ................................................................................................... 9 
2. 3.  
RI S K/ B E N E FI T P R O FI L E ........................................................................................................... 1 0  
2. 3. 1.  
P ot e nti al St u d y Ri s k s .......................................................................................................... 1 0  
2. 3. 2.  
P ot e nti al St u d y B e n efit s ...................................................................................................... 1 0  
2. 3. 3.  
A s s e s s m e nt of P ot e nti al Ri s k/ B e n efit Pr ofil e ...................................................................... 1 0  
3.  
O B J E C TI V E S A N D E N D P OI N T S ........................................................................................................ 1 0  
4.  
S T U D Y D E SI G N .................................................................................................................................. 1 2  
4. 1.  
O V E R A L L D E SI G N ..................................................................................................................... 1 1  
4. 2.  
E N D O F S T U D Y D E FI NI TI O N .................................................................................................... 1 1  
5.  
S T U D Y P O P U L A TI O N ......................................................................................................................... 1 1  
5. 1.  
I N C L U SI O N C RI T E RI A ............................................................................................................... 1 1  
5. 2.  
E X C L U SI O N C RI T E RI A .............................................................................................................. 1 1  
5. 3.  
S T R A T E GI E S F O R R E C R UI T M E N T A N D R E T E N TI O N ........................................................... 1 2  
6.  
S T U D Y P R O C E D U R E S A N D A S S E S S M E N T S .................................................................................. 1 2  
7.  
A D V E R S E E V E N T S ............................................................................................................................ 1 4  
7. 1.  
D efi niti o n of A d v er s e E v e nt ......................................................................................................... 1 4  
7. 2.  
D efi niti o n of S eri o u s A d v er s e E v e nt ............................................................................................ 1 4  
7. 3.  
S e v erit y of A d v er s e E v e nt ........................................................................................................... 1 5  
7. 4.  
R el at e d n e s s of A d v er s e E v e nt a n d S eri o u s A d v er s e E v e nt ....................................................... 1 5  
7. 5.  
E x p e ct e d n e s s .............................................................................................................................. 1 5  
7. 6.  
A d v er s e E v e nt R e p orti n g ............................................................................................................ 1 5  
7. 7.  
S eri o u s A d v er s e E v e nt R e p orti n g ............................................................................................... 1 6  

M e dli n e I n d u stri e s, I n c. 
 
 
Fi brill ar dr e s si n g f or tr e ati n g c hr o ni c, st all e d w o u n d s  
M E D- 2 0 1 8- DI V 7 1- 0 0 8 
 
C O N FI D E N TI A L                        
2 3 A u g u st 2 0 1 8 
V 1 . 0 
 
           
3 
 
8.  
S T A TI S TI C A L C O N SI D E R A TI O N S ..................................................................................................... 1 6  
8. 1.  
S A M P L E SI Z E D E T E R MI N A TI O N .............................................................................................. 1 6  
8. 2.  
P O P U L A TI O N S F O R A N A L Y S E S .............................................................................................. 1 6  
8. 3.  
D A T A A N A L Y SI S ........................................................................................................................ 1 6  
9.  
S U P P O R TI N G D O C U M E N T A TI O N A N D O P E R A TI O N A L C O N SI D E R A TI O N S ............................... 1 7  
9. 1.  
K E Y R O L E S A N D S T U D Y G O V E R N A N C E ............................................................................... 1 7  
9. 2.  
C LI NI C A L M O NI T O RI N G ............................................................................................................ 1 7  
9. 3.  
R E G U L A T O R Y A N D E T HI C A L C O N SI D E R A TI O N S ................................................................. 1 8  
9. 3. 1.  
C o nfi d e nti alit y a n d Pri v a c y .................................................................................................. 1 9  
9. 3. 2.  
S af et y O v er si g ht .................................................................................................................. 1 9  
9. 3. 3.  
St u d y Di s c o nti n u ati o n ......................................................................................................... 2 0  
9. 3. 4.  
St u d y Cl o s e o ut .................................................................................................................... 2 0  
9. 3. 5.  
D at a h a n dli n g a n d R e c or d K e e pi n g .................................................................................... 2 0  
9. 3. 6.  
C o nfli ct of I nt er e st P oli c y ..................................................................................................... 2 0  
9. 4.  
P R O T O C O L D E VI A TI O N S ......................................................................................................... 2 0  
9. 5.  
A B B R E VI A TI O N S ....................................................................................................................... 2 1  
1 0.  
R E F E R E N C E S ................................................................................................................................ 2 1  
1 1.  
A P P E N DI X ...................................................................................................................................... 2 3  
 
 
 
 
 
 
 
 
 

M e dli n e I n d u stri e s, I n c. 
 
 
Fi brill ar dr e s si n g f or tr e ati n g c hr o ni c, st all e d w o u n d s  
M E D- 2 0 1 8- DI V 7 1- 0 0 8 
 
C O N FI D E N TI A L                        
2 3 A u g u st 2 0 1 8 
V 1 . 0 
 
           
4 
 
I N V E S TI G A T O R A C K N O W L E D G M E N T SI G N A T U R E 
 
 
I a gree t o c o n d uct t he st u d y i n acc or da nce wit h t he rele va nt, c urre nt pr ot oc ol 
a n d will ma ke c ha n ges i n t he pr ot oc ol o nl y after n otif yi n g t he S p o ns or, e xce pt 
w he n necessar y t o pr otect t he safet y, ri g hts, or welfare of s u bjects. 
 
I a gree t o pers o nall y c o n d uct a n d s u per vise t he i n vesti gati o n as descri be d wit hi n. 
 
I a gree t o i nf or m all s u bjects t hat t he de vice is bei n g use d f or t he p ur p oses of a n 
i n vesti gati o nal st u d y.  
 
I will e ns ure t hat re q uire me nts relati n g t o o btai ni n g i nf or me d c o nse nt i n t he 
g ui deli nes f or G o o d Cli nical Practices, a n d 2 1 C F R Part 5 0 a n d i nstit uti o nal 
re vie w b oar d (I R B) re vie w a n d a p pr o val i n 2 1 C F R Part 5 6 are met. 
 
I a gree t o re p ort t o t he S p o ns or, I R B a n d/ or Et hics C o m mittee, acc or di n g t o t he 
pr ot oc ol, a d verse e x perie nces t hat occ ur d uri n g t he c o urse of t he i n vesti gati o n i n 
acc or da nce wit h  g ui deli nes f or G o o d Cli nical Practices, a n d 2 1 C F R 8 1 2. 
 
I ha ve rea d a n d u n dersta n d t he i nf or mati o n i n t he pr ot oc ol, i ncl u di n g t he p ote ntial 
ris ks. 
 
I a gree t o mai ntai n a de q uate a n d acc urate rec or ds i n acc or da nce wit h g ui deli nes 
f or G o o d Cli nical Practices a n d 2 1 C F R 8 1 2. 1 4 0 a n d t o ma ke t h ose rec or ds 
a vaila ble f or i ns pecti o n. 
 
I will e ns ure t hat a n I R B c o m plia nt wit h t he re q uire me nts of g ui deli nes f or G o o d 
Cli nical Practices a n d 2 1 C F R Part 5 6 will be res p o nsi ble f or t he i nitial a n d 
c o nti n ui n g re vie w a n d a p pr o val of t he cli nical i n vesti gati o n. I als o a gree t o 
pr o m ptl y re p ort t o t he I R B all c ha n ges i n t he researc h acti vit y a n d all 
u na ntici pate d pr o ble ms i n v ol vi n g ris ks t o h u ma n s u bjects or ot hers.  
 
I a gree t o c o m pl y wit h all ot her re q uire me nts re gar di n g t he o bli gati o ns of cli nical 
i n vesti gat ors a n d all ot her perti ne nt re q uire me nts i n t he g ui deli nes f or G o o d 
Cli nical Practices, a n d t he C o de of Fe deral Re g ulati o ns. 
I ha ve recei ve d a n d re vie we d t his I n vesti gati o nal Pla n. I will c o n d uct t he st u d y as descri be d. 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _              _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 
           
 
I n vesti gat or’s Si g nat ure     
        
        
           Date 
 
 
 

M e dli n e I n d u stri e s, I n c. 
 
 
Fi brill ar dr e s si n g f or tr e ati n g c hr o ni c, st all e d w o u n d s  
M E D- 2 0 1 8- DI V 7 1- 0 0 8 
 
C O N FI D E N TI A L                        
2 3 A u g u st 2 0 1 8 
V 1 . 0 
 
           
5 
 
D O C U M E N T HI S T O R Y 
 
V E R SI O N  
D A T E  
D E S C RI P TI O N  
1 . 0 
2 3 -A u g ust -2 0 1 8  
I nitial Release 
 
 

M e dli n e I n d u stri e s, I n c. 
 
 
Fi brill ar dr e s si n g f or tr e ati n g c hr o ni c, st all e d w o u n d s  
M E D- 2 0 1 8- DI V 7 1- 0 0 8 
 
C O N FI D E N TI A L                        
2 3 A u g u st 2 0 1 8 
V 1 . 0 
 
           
6 
 
1.  P R O T O C O L S U M M A R Y 
1. 1.  S y n o psis 
 
Titl e:  
A pr os p ectiv e c as e s eri es ev al u ati n g a fi brill ar c oll a g e n p o w d er 
dr essi n g t o tr e at c hr o nic, st all e d l o w er -extr e mity w o u n ds  
 
 
St u d y D e s cri pti o n : 
C hr o nic w o u n ds ar e a s o urc e of si g nific a nt m or bi dity a n d esc al ati n g 
h e alt hc ar e c osts. T h e w o u n d c ar e pr of essi o n al h as a myri a d of 
m o d er n w o u n d dr essi n gs t o c h o os e fr o m w h e n tr e ati n g a w o u n d, 
e ac h  of w hic h h as  b e n efits a n d dr a w b acks. A n u n d erst a n di n g of h o w  
a giv e n dr essi n g p erf or ms i n h e ali n g a p artic ul ar w o u n d is cr uci al i n 
or d er t o d et er mi n e a cli nic al m a p pi n g of w o u n d dr essi n gs t o w o u n d 
ty p es; s uc h a c at e g oriz ati o n w o ul d l e a d t o m or e effici e nt cli nic al 
d ecisi o n m aki n g a n d b ett er p ati e nt o utc o m es. T his c a s e s eri es will 
ev al u at e t h e a bility of a fi brill ar c oll a g e n p o w d er t o i m pr ov e h e al i n g 
of  c hr o nic, st all e d, l o w er -extr e mity w o u n ds.  
 
O bj e cti v e s:  
 
Ev al u at e t h e a bility of a fi brill ar c oll a g e n p o w d er dr essi n g t o tr e at 
c hr o nic, st all e d, l o w er -extr e mity w o u n ds  
 
 
 
 
E n d p oi nt s:  
Pri m ar y: C h a n g e i n w o u n d siz e ov er t w elv e w e ek p eri o d  
S ec o n d ar y:  1) C h a n g e i n B at es -J e ns e n 
W o un d Ass ess m e nt T o ol 
sc or e, 2) C h a n g e i n  r e p ort e d p ai n l ev el .   
 
St u d y P o p ul ati o n:  
T w e nty  a d ult p ati e nts wit h c hr o nic l o w er -extr e mity w o u n ds (i. e. 
b el o w t h e k n e e) of gr e at er t h a n f o ur w e eks t h at h av e f ail e d t o 
r es p o n d t o at l e ast o n e a dv a nc e d w o u n d dr essi n g tr e at m e nt. 
S p ecific w o u n d ty p es i ncl u d e: pr ess ur e ulc ers, di a b etic ulc ers, 
a n d 
v e n o us l e g ulc ers.  
 
P h a s e:  
P ost -M ark et  
 
D e s cri pti o n of 
Sit e s / F a ciliti e s 
E nr olli n g 
P arti ci p a nt s : 
 
O ut p ati e nt p o di atry cli nics i n t h e U nit e d St at es  
D e s cri pti o n of St u d y  
I nt er v e nti o n: 
P ati e nts w h o 
m e et t h e i ncl usi o n crit eri a will b e pr ovi d e d wit h 
fi brill ar c oll a g e n p o w d er dr essi n g ( P ur ac ol ® 
Ultr a P o w d er by 
M e dli n e I n d ustri es, I nc.). T h e p o w d er dr essi n g will b e us e d i n 

M e dli n e I n d u stri e s, I n c. 
 
 
Fi brill ar dr e s si n g f or tr e ati n g c hr o ni c, st all e d w o u n d s  
M E D- 2 0 1 8- DI V 7 1- 0 0 8 
 
C O N FI D E N TI A L                        
2 3 A u g u st 2 0 1 8 
V 1 . 0 
 
           
7 
 
acc or d a nc e wit h its l a b el. Aft er cl e a nsi n g t h e w o u n d  by t h e cli nic al 
sit e st aff , t h e p o w d er is pl ac e d dir ectly o n t h e w o u n d , a n d t h e n t h e 
w o u n d will b e c ov er e d wit h a n a p pr o pri at e 
m oist ur e r et e ntiv e 
s ec o n d ary dr essi n g. P ati e nts will visit t h e cli nic t wic e a w e ek t o h av e 
t h e p o w d er r e-a p pli e d . W o u n d ev al u ati o ns will t ak e pl ac e o nc e a 
w e ek at t h e o ut p ati e nt cli nic, wit h t h e i nt erv e nti o n l asti n g u p t o 
t w elv e w e eks. C o nc urr e nt st a n d ar d of c ar e, s uc h as c o m pr essi o n f or 
v e n o us ulc ers, will b e pr ovi d e d.  
 
St u d y D ur ati o n:  
T ot al ti m e f or st u dy c o m pl et i o n t o all o w accr u al of all s u bj ects, a n d 
a p pr o pri at e tr e at m e nt as p er t h e pr ot oc ol,  will b e a p pr oxi m at ely 
1 2 -1 8 m o nt hs  
 
P arti ci p a n t D ur ati o n: P artici p a nt d ur ati o n i n t h e st u dy will b e a m axi m u m of t w elv e 
w e eks. I n t h e ev e nt a p artici p a nt’s w o u n d 
c o m pl et ely h e als pri or t o 
t h e e n d of t w elv e w e eks, his or h er p artici p ati o n i n t h e st u dy will b e 
c o m pl et e at t h e ti m e of c o m pl et e w o u n d h e ali n g.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

M e dli n e I n d u stri e s, I n c. 
 
 
Fi brill ar dr e s si n g f or tr e ati n g c hr o ni c, st all e d w o u n d s  
M E D- 2 0 1 8- DI V 7 1- 0 0 8 
 
C O N FI D E N TI A L                        
2 3 A u g u st 2 0 1 8 
V 1 . 0 
 
           
8 
 
1. 2.  Sc he d ule of Acti vities ( S O A) 
 
 
R E Q UI R E D 
A S S E S S M E N T S  
P R E -
S C R E E NI N G  
Da y -1  
S C R E E NI N G VI SI T  
Da y 0  
 ( Ma y be c o m bi ne d 
wit h I nitial V isit, Da y 
1)  
I NI TI A L 
VI SI T  
Da y 1  
 
D R E S SI N G 
C H A N G E 
VI SI T S  
T wice wee kl y 
( E ver y 3 da ys ± 
1 da y)  
 
W O U N D 
A S S E S S M E N T 
VI SI T S  
O nce per wee k  
E ver y 7 da ys ± 2 da ys  
( Ma y be c o m bi ne d wit h 
Dressi n g C ha n ge Visit)  
FI N A L VI SI T  
1 2 wee ks fr o m I nitial 
Visit 3  
Pre -Scree ni n g 
Q uesti o n naire 
1  
X   
 
 
 
 
 
 
I nf or me d C o nse nt  
 
X  
 
 
 
 
Scree ni n g F or m  t o 
assess eli gi bilit y  
 
X  
 
 
 
 
Decisi o n o n 
eli gi bilit y  
 
X  
 
 
 
 
De m o gra p hics  
 
 
X  
 
 
 
W o u n d Hist or y  
 
 
X  
 
 
 
W o u n d P h ot o gra p h  
 
 
X  
 
X  
X  
Bates -Je nse n W o u n d 
Assess me nt  
 
 
X  
 
X  
X  
A p plicati o n of 
P urac ol ®  Ultra  
 
 
X  
X  
X 2 
 
Pai n Assess me nt  f or 
dressi n g c ha n ge  
 
 
X  
 
X  
X  
Sec o n dar y Dressi n g 
N otati o n  
 
 
X  
X  
X 2  
 
A d verse E ve nt 
Assess me nt  
 
X  
X  
X  
X  
X  
1 : F or partici pa nts c o ntacti n g t he researc h facilit y, 2 : If c o m bi ne d wit h Dressi n g c ha n ge visit, 3 : Fi nal visit ma y occ ur earlier i n t he e ve nt t he partici pa nt’s 
w o u n d has c o m pletel y heale d bef ore 1 2 wee ks  

M e dli n e I n d u stri e s, I n c. 
 
 
Fi brill ar dr e s si n g f or tr e ati n g c hr o ni c, st all e d w o u n d s  
M E D- 2 0 1 8- DI V 7 1- 0 0 8 
 
C O N FI D E N TI A L                        
2 3 A u g u st 2 0 1 8 
V 1 . 0 
 
           
9 
 
 
2.  I N T R O D U C TI O N  
2. 1.  B ac k gr o u n d & R ati o n ale  
C hr o nic w o u n ds, d efi n e d as d a m a g e t o e pi d er m al or d er m al str uct ur es pr es e nt f or gr e at er t h a n f o ur 
w e eks wit h o ut si g nific a nt cli nic al i m pr ov e m e nt , i n s pit e of a p pr o pri at e cli nic al 
m a n a g e m e nt, 
r e pr es e nt a s u bst a nti al b ur d e n o n t h e h e alt hc ar e syst e m. C osts f or v e n o us l e g ulc ers, a w o u n d ty p e 
t h at oft e n b ec o m es c hr o nic , w er e esti m at e d at $ 3 billi o n a n n u ally as of 2 0 0 6.
1 Ot h er w o u n d ty p es, 
s uc h as pr ess ur e ulc ers a n d di a b etic ulc ers c a n als o t ur n i nt o c hr o nic w o u n ds, a d di n g t o h e alt hc ar e 
c osts a n d n e g ativ ely i m p acti n g q u ality of lif e. T h es e ty p es of w o u n ds fr e q u e ntly occ ur i n t h e l o w er 
extr e miti es d u e t o v e n o us or art eri al i ns uffici e ncy a n d pr ess ur e ex ert e d o n t h e f o ot or l e g.  
A k ey f act or i n w o u n d h e ali n g is t h e pr o d ucti o n, d e p ositi o n, a n d i nt e gr ati o n of c oll a g e n i n t h e 
w o u n d b e d. C oll a g e n is t h e m ost a b u n d a nt pr ot ei n i n t h e h u m a n b o dy, a n d it pl ays a k ey r ol e i n all 
p h as es of w o u n d h e ali n g. 2 I n c hr o nic w o u n ds, t h e d e p ositi o n of d e n ov o  c oll a g e n is d el ay e d a n d/ or 
alt er e d. 3, 4  I n t h es e w o u n ds t h er e is b ot h a r e d ucti o n of c oll a g e n d e p ositi o n, c o u pl e d wit h i ncr e as e d 
br e ak d o w n of t h e c oll a g e n t h at d o es g et d e p osit e d, t h at pr ev e nts it fr o m i nt e gr ati n g i nt o t h e w o u n d 
b e d a n d h e ali n g t h e w o u n d.  
I n a n eff ort t o a u g m e nt t h e f or m ati o n a n d i nt e gr ati o n of c oll a g e n i nt o t h e w o u n d b e d, h e alt hc ar e 
pr of essi o n als oft e n t ur n t o c oll a g e n b as e d dr essi n gs. T h es e dr essi n gs ar e c o m p os e d of b ovi n e, 
p orci n e, or avi a n c oll a g e n; t h e dr essi n gs ar e oft e n i n t h e f or m of a s h e et t h at c a n b e a p pli e d dir ectly 
t o t h e w o u n d or a p o w d er t h at is s pri nkl e d ov er t h e w o u n d. T h e i nfl ux of c oll a g e n ai ds i n a d dr essi n g 
t h e micr o e nvir o n m e nt of t h e w o u n d, w hic h m ay pr ovi d e a diff er e nt m ec h a nis m of acti o n f or h e ali n g 
c o m p ar e d t o ot h er a dv a nc e d w o u n d tr e at m e nts, w hic h oft e n a d dr ess t h e m acr o e nvir o n m e nt ( e. g. 
m oist ur e r et e ntiv e dr essi n gs). D u e t o t his, c oll a g e n dr essi n gs m ay b e p artic ul arly us ef ul f or c hr o nic 
w o u n ds t h at h av e n ot r es p o n d e d t o ot h er a dv a nc e d w o u n d tr e at m e nts, s uc h as silv er s ulf a di azi n e, 
c alci u m al gi n at e, or hy dr oc oll oi d dr essi n gs. I n d e e d, a c as e s eri es of t w e nty p ati e nts wit h c hr o nic, 
st all e d w o u n ds d e m o nstr at e d t h e a bility of a b ovi n e- b as e d c oll a g e n dr essi n g t o a dv a nc e t h e h e ali n g 
of t h es e w o u n ds. 2 I n t h e c urr e nt st u dy, a n ov el, p orci n e- b as e d p o w d er dr essi n g will b e ev al u at e d i n 
or d er t o d et er mi n e if it c a n ac hi ev e si mil ar e n ds.  
2. 2.  I n vesti g ati o n al Pr o d uct 
P ur ac ol ® Ultr a P o w d er c oll a g e n w o u n d dr essi n g is a p o w d er-lik e fi brill ar c oll a g e n micr os p o n g e 
c o m p os e d of Ty p e I p orci n e d er mis c oll a g e n. T h e dr essi n g is a c urr e ntly m ark et e d, cl e ar e d d evic e i n 
t h e U nit e d St at es, i n dic at e d f or t h e m a n a g e m e nt of f ull a n d p arti al t hick n ess w o u n ds, i ncl u di n g: 
pr ess ur e ulc ers, di a b etic ulc ers c a us e d by mix e d v asc ul ar ori gi n, v e n o us ulc ers, a n d s ev er al ot h er 
w o u n d ty p es. A p p e n dix 1 1. 1 . 1 pr ovi d es t h e l a b el a n d i nstr ucti o ns f or us e (I F U) f or t h e d evic e.   
As P ur ac ol ® Ultr a c o m es i n p o w d er f or m, a s ec o n d ary dr essi n g a p pli e d ov er t h e w o u n d is n ec ess ary. 
A n a p pr o pri at e siz e d dr essi n g fr o m t h e O ptif o a m ® G e ntl e silic o n e b or d er s eri es by 
M e dli n e 
I n d ustri es I nc., will b e a p pli e d. I nf or m ati o n p ert ai ni n g t o t h es e dr essi n gs is pr ovi d e d i n A p p e n dix 
1 1. 1. 2. F urt h er m or e, giv e n t h at t h e st a n d ar d of c ar e f or p ati e nts wit h v e n o us ulc ers e nt ails 

M e dli n e I n d u stri e s, I n c. 
 
 
Fi brill ar dr e s si n g f or tr e ati n g c hr o ni c, st all e d w o u n d s  
M E D- 2 0 1 8- DI V 7 1- 0 0 8 
 
C O N FI D E N TI A L                        
2 3 A u g u st 2 0 1 8 
V 1 . 0 
 
 
1 0  
 
a p plic ati o n of a c o m pr essi o n dr essi n g, p ati e nts wit h t h es e ty p es of w o u n ds will als o r ec eiv e C o Fl ex ® 
TL C T w o-L ay er C o m pr essi o n Syst e m dr essi n g; t his dr essi n g is c urr e ntly 
m ark et e d f or t h e 
m a n a g e m e nt of v e n o us ulc ers. M or e i nf or m ati o n r e g ar di n g t h e C o Fl ex ® TL C T w o-L ay er C o m pr essi o n 
Syst e m dr essi n g is av ail a bl e i n A p p e n dix 1 1. 1. 3. 
2. 3.  Ris k/ Be nefit Pr ofile 
2. 3. 1.  P ote ntial St u d y Ris ks 
P artici p a nts m ay ex p eri e nc e irrit ati o n or a r e d d e ni n g d u e t o t h e dr essi n g. P artici p a nts will b e 
u n d er t h e c ar e of a h e alt hc ar e pr of essi o n al w hil e usi n g t h e dr essi n g, a n d h e or s h e will b e a bl e 
t o i nt erv e n e a p pr o pri at ely if t h e dr essi n g c a us es a ny irrit ati o n or r e d d e ni n g. 
2. 3. 2.  P ote ntial St u d y Be nefits 
P artici p a nts m ay ex p eri e nc e a h e ali n g of t h eir c hr o nic, st all e d w o u n d as a r es ult of t h e st u dy 
pr o d uct a p plic ati o n.  
2. 3. 3.  Assess me nt of P ote ntial Ris k/ Be nefit Pr ofile 
T h e st u dy pr o d uct will b e us e d i n acc or d a nc e wit h its c urr e ntly m ark et e d IF U, a n d t h e risks t o 
p artici p a nts ar e 
mi n or. P artici p a nts 
m ay ex p eri e nc e h e ali n g of t h eir w o u n d t hr o u g h t h e 
a p plic ati o n of t h e dr essi n g. D u e t o t his, t h e risk/ b e n efit pr ofil e is f av or a bl e.  
3.  O B J E C TI V E S A N D E N D P OI N T S 
 
O B J E C TI V E S  
E N D P OI N T S  
J U S TI FI C A TI O N 
F O R E N D P OI N T S  
 
 
 
Ev al u at e t h e a bility of a fi brill ar 
c oll a g e n p o w d er dr essi n g t o tr e at 
c hr o nic, st all e d, l o w er -extr e mity 
w o u n ds.  
Pri m ar y  
 
C h a n g e i n w o u n d siz e  
 
 
 
A r e d ucti o n i n 
w o u n d siz e is 
i n dic ativ e of 
h e ali n g  
 
S ec o n d ar y  
 
C h a n g e i n B W A T sc or e  
 
C h a n g e i n r e p ort e d p ai n l ev el  
o  G e n er al p ai n l ev el  
o  P ai n l ev el at dr essi n g 
c h a n g e  
 
T h e B W A T is a 
v ali d at e d t o ol f or 
w o u n d h e ali n g  
 
P ai n is i n dic ativ e of 
h e ali n g a n d w o u n d 
st at us 

M e dli n e I n d u stri e s, I n c. 
 
 
Fi brill ar dr e s si n g f or tr e ati n g c hr o ni c, st all e d w o u n d s  
M E D- 2 0 1 8- DI V 7 1- 0 0 8 
 
C O N FI D E N TI A L                        
2 3 A u g u st 2 0 1 8 
V 1 . 0 
 
 
1 1  
 
4.  S T U D Y D E SI G N 
4. 1.  O ver all Desi g n 
T his is a pr os p ectiv e, o p e n-l a b el, c as e s eri es i nv esti g ati n g if a c urr e ntly m ark et e d c oll a g e n dr essi n g 
c a n r es ult i n i m pr ov e d h e ali n g of c hr o nic, st all e d, l o w er- extr e mity w o u n ds. A n o ut p ati e nt p o di atry 
cli nic will e nr oll t w e nty p ati e nts wit h q u alifyi n g w o u n ds a n d m o nit or w o u n d h e ali n g pr o gr ess ov er 
t h e c o urs e of t w elv e w e eks.  
4. 2.  E n d of St u d y Defi niti o n  
T h e c o ncl usi o n of t h e st u dy f or a n i n divi d u al p artici p a nt will occ ur at t h eir l ast W o u n d Ass ess m e nt 
Visit, w hic h will b e aft er t w elv e w e eks of p artici p ati o n or w h e n t h e w o u n d is c o m pl et ely h e al e d, 
w hic h ev er c o m es first. T h e st u dy will b e d e e m e d c o m pl et e u p o n iss u a nc e of t h e fi n al Cli nic al St u dy 
R e p ort.  
5.  S T U D Y P O P U L A TI O N  
5. 1.  I ncl usi o n Criteri a 
I n or d er t o p artici p at e i n t h e st u dy, a p artici p a nt m ust m e et ALL  of t h e f oll o wi n g crit eri a: 
 
A g e 1 8 +  
 
H as o n e of t h e f oll o wi n g ty p es of w o u n ds b el o w t h e k n e e:  
o  Di a b etic ulc ers 
o  Pr ess ur e ulc ers 
o  V e n o us ulc ers 
o  Ulc ers of mix e d-v asc ul ar ori gi n 
o  Tr a u m atic w o u n ds 
o  P ost-s ur gic al w o u n ds 
 
W o u n d h as b e e n pr es e nt f or at l e ast f o ur w e eks 
 
W o u n d is fr e e of n ecr otic tiss u e or d e bri d e m e nt pr actic es will t ak e pl ac e pri or t o i niti al 
visit i n or d er t o r e m ov e n ecr otic tiss u e. 
 
W o u n d h as n ot r es p o n d e d t o at l e ast o n e ty p e of a dv a nc e d w o ul d c ar e tr e at m e nt 
 
W o u n d siz e is b et w e e n 1 a n d 1 0 0 c m
2 
 
P ati e nt h as a d e q u at e circ ul ati o n as d e m o nstr at e d by bi p h asic or tri p h asic D o p pl er 
w av ef or m, m e as ur e d wit hi n t hr e e m o nt hs pri or t o st u dy e nr oll m e nt. If m o n o p h asic o n 
ex a m, t h e n n o n-i nv asiv e t ests m ust dis pl ay A nkl e Br ac hi al I n d ex gr e at er t h a n 0. 8 a n d 
n o w ors e t h a n mil d dis e as e o n s e g m e nt al pr ess ur es.  
 
W o u n d is c o nfir m e d as b ei n g fr e e of i nf ecti o n a n d a bs e nc e of ost e o my elitis. 
5. 2.  E xcl usi o n Criteri a 
A p artici p a nt m ust n ot m e et A N Y of t h e crit eri a b el o w t o p artici p at e i n t h e st u dy 
 
Pr e g n a nt, pl a n ni n g t o b ec o m e pr e g n a nt d uri n g t h e st u dy ti m efr a m e, or br e ast f e e di n g 
 
U n a bl e or u n willi n g t o r ec eiv e p orci n e c oll a g e n 

M e dli n e I n d u stri e s, I n c. 
 
 
Fi brill ar dr e s si n g f or tr e ati n g c hr o ni c, st all e d w o u n d s  
M E D- 2 0 1 8- DI V 7 1- 0 0 8 
 
C O N FI D E N TI A L                        
2 3 A u g u st 2 0 1 8 
V 1 . 0 
 
 
1 2  
 
 
W o u n d is i nf ect e d or pr es e nc e of ost e o my elitis 
 
All er gy or s e nsitivity t o c oll a g e n 
 
I n a bility, i n t h e o pi ni o n of t h e I nv esti g at or t o f oll o w pr ot oc ol r e q uir e m e nts, att e n d 
f oll o w u p visits i n a ti m ely m a n n er , or ot h er wis e c o m ply wit h t h e r e q uir e m e nts of t h e 
pr ot oc ol 
 
5. 3.  Str ate gies f or Recr uit me nt a n d Rete nti o n  
T h e  Pri nci p al I nv esti g at or ( PI) m ai nt ai ns a n o ut p ati e nt p o di atry cli nic. T h e PI  a n d/ or sit e st aff will 
off er e nr oll m e nt t o p ati e nts t h at m ay m e et t h e i ncl usi o n/ excl usi o n crit eri a.  P artici p a nts will b e 
pr ovi d e d wit h r e mi n d er n otific ati o ns a n d d oc u m e nt ati o n d et aili n g t h eir sc h e d ul e d visits t o t h e sit e.  
6.  S T U D Y P R O C E D U R E S A N D A S S E S S M E N T S 
6. 1.  D a y - 1 –  Pre-scree ni n g 
I nt er est e d p ot e nti al p artici p a nts w h o c o nt act t h e r es e arc h sit e will u n d er g o a bri ef pr e-scr e e ni n g 
q u esti o n n air e vi a p h o n e t o d et er mi n e i niti al eli gi bility. P ot e nti al p artici p a nts will b e assi g n e d a 
scr e e ni n g n u m b er i n or d er t o d e-i d e ntify t h e i nf or m ati o n o n t h e f or m. T h e pr e-scr e e ni n g f or m c a n 
b e f o u n d i n A p p e n dix 1 1. 2. 1.  
6. 2.  D a y 0 - I nf or me d C o nse nt a n d Scree ni n g Visit 
6. 2. 1.  I nf or me d C o nse nt 
U p o n arriv al t o t h e st u dy sit e, r es e arc h st aff will pr ovi d e p ot e nti al p artici p a nts wit h a writt e n 
i nf or m e d c o ns e nt f or m (I C F) t h at h as r ec eiv e d a p pr ov al by a n i nstit uti o n al r evi e w b o ar d (I R B) or 
Et hics C o m mitt e e. T h e I C F will b e writt e n a n d a d mi nist er e d i n c o m pli a nc e wit h G o o d Cli nic al 
Pr actic e ( G C P) a n d c o m ply wit h all el e m e nts r e q uir e d by F D A 2 1 CF R 5 0. 2 5, I nt er n ati o n al 
C o nf er e nc e o n H ar m o niz ati o n (I C H), a n d st at e a n d l oc al r e g ul ati o ns. R es e arc h st aff will a ns w er 
a ny q u esti o ns t h e p ot e nti al p artici p a nt h as r e g ar di n g t h e f or m. 
Writt e n c o ns e nt fr o m t h e 
p artici p a nt m ust b e o bt ai n e d pri or t o c o n d ucti n g a ny ot h er r es e arc h activiti es. A c o py of t h e 
si g n e d I C F will b e off er e d t o e ac h p artici p a nt.    
6. 2. 2.  Scree ni n g 
Aft er o bt ai ni n g i nf or m e d c o ns e nt, r es e arc h st aff will ass ess eli gi bility t o p artici p at e i n t h e st u dy 
usi n g t h e scr e e ni n g f or m pr ovi d e d i n A p p e n dix 1 1. 2. 2. P artici p a nts w h o q u alify will b e assi g n e d 
a s u bj ect n u m b er.  I n t h e ev e nt t h e p ot e nti al s u bj ect h as n ot h a d a m e as ur e m e nt t o d et er mi n e 
a d e q u at e bl o o d fl o w i n t h e p ast t hr e e m o nt hs, t h e PI or r es e arc h st aff will ass ess bl o o d fl o w vi a 
a h a n d h el d v asc ul ar D o p pl er d evic e. S u bj ects m ust m e et t h e D o p pl er crit eri a m e nti o n e d i n 
s ecti o n 5. 1 of t his pr ot oc ol t o b e r a n d o miz e d 

M e dli n e I n d u stri e s, I n c. 
 
 
Fi brill ar dr e s si n g f or tr e ati n g c hr o ni c, st all e d w o u n d s  
M E D- 2 0 1 8- DI V 7 1- 0 0 8 
 
C O N FI D E N TI A L                        
2 3 A u g u st 2 0 1 8 
V 1 . 0 
 
 
1 3  
 
6. 3.  D a y 1 –  I niti al Visit 
6. 3. 1.  De m o gra p hic a n d Baseli ne Data C ollecti o n 
T h e PI  or r es e arc h st aff will c oll ect t h e f oll o wi n g d e m o gr a p hic d at a a n d m e dic al i nf or m ati o n: 
a g e, g e n d er, r ac e, h ei g ht, w ei g ht, m e dic al di a g n os es, w o u n d l oc ati o n, w o u n d ty p e, d ur ati o n of 
w o u n d, a n d pri or tr e at m e nts. T h es e d at a will b e r ec or d e d o n t h e I niti al Visit C as e R e p ort F or m 
( C RF), pr ovi d e d i n A p p e n dix 1 1. 3. 1.   
6. 3. 2.  P h ot o gra p h of W o u n d  a n d W o u n d Size Meas ure me nt 
M e as ur e m e nt of w o u n d siz e will occ ur vi a s oft w ar e pr ovi d e d wit h a n acc e pt a bl e w o u n d c a m er a, 
t o b e pr ovi d e d by M e dli n e. T h e PI will t ak e a p h ot o gr a p h of t h e w o u n d wit h t h e c a m er a a n d 
u pl o a d t h e fil e t o a c o m p ut er wit h a p pr o pri at e s oft w ar e. T h e s oft w ar e will a ut o m atic ally 
c alc ul at e t h e w o u n d siz e; t his will s erv e as t h e w o u n d siz e d at a p oi nt f or t h e I niti al Visit. W o u n d 
siz e, i n c m 2 will b e r ec or d e d o n t h e W o u n d P h ot o C R F; a c o py of t h e C RF is pr ovi d e d i n A p p e n dix 
1 1. 3. 2.  
6. 3. 3.  Pai n Assess me nt 
P artici p a nts will v er b ally r at e t h eir p erc eiv e d p ai n l ev el t wic e d uri n g 
t h e visit. A “c urr e nt” p ai n 
l ev el will b e c a pt ur e d by aski n g t h e p artici p a nt his/ h er c urr e nt p ai n d uri n g t h e visit; t his 
m e as ur e m e nt will b e o bt ai n e d at t h e b e gi n ni n g of t h e visit. If d e bri d e m e nt is t o b e p erf or m e d 
d uri n g t h e visit, t h e “c urr e nt” p ai n ev al u ati o n will occ ur pri or t o d e bri d e m e nt. A d diti o n ally, a 
p ai n l ev el d uri n g dr essi n g c h a n g es will als o b e ac q uir e d. P artici p a nts will us e a 0- 1 0 V er b al 
N u m eric P ai n R ati n g sc al e, wit h 0 c orr es p o n di n g t o mi ni m al p ai n a n d 1 0 i n dic ati n g t h e w orst 
p ai n i m a gi n a bl e. T h e v al u e will b e r ec or d e d o n t h e W o u n d P h ot o C RF.  
6. 3. 4.  Bates-Je nse n W o u n d Assess me nt T o ol 
T h e PI or r es e arc h st aff will a d mi nist er t h e B at es-J e ns e n W o u n d Ass ess m e nt T o ol ( B W A T) at t h e 
I niti al Visit i n or d er t o g ai n a n u n d erst a n di n g of t h e w o u n d c h ar act eristics. T h e i nstr ucti o ns f or 
us e f or t h e B W A T ar e pr ovi d e d i n S ecti o n 1 1. 3. 3. 1, wit h t h e act u al t o ol t h at will s erv e as t h e C RF 
i n S ecti o n 1 1. 3. 3. 2. I n or d er t o c o nv ert t h e B W A T i nt o a t o ol t h at is c o m p ati bl e wit h t h e 
i di osy ncr asi es of t his st u dy, a f e w mi n or c h a n g es w er e m a d e. T h e fi el d f or “ N a m e” w as c h a n g e d 
t o “S u bj ect N u m b er.” I n a d diti o n, a fi el d f or “ D at e” a n d “ W o u n d Ass ess m e nt N u m b er” w er e 
list e d f or tr acki n g p ur p os es, giv e n t h e m ulti pl e visits t h at will occ ur wit h t his st u dy. Als o, t h e 
B W A T c o nt ai ns t hr e e c ol u m ns f or sc ori n g, e ac h c orr es p o n di n g t o a s e p ar at e d at e a n d 
ass ess m e nt. I n t his st u dy t h er e will lik ely b e m or e t h a n t hr e e visits f or e ac h s u bj ect, s o w e h av e 
d el et e d t w o of t h e c ol u m ns t o av oi d c o nf usi o n; a n e w B W A T C R F will b e us e d f or e ac h visit. 
Si mil arly, t h e i nstr ucti o ns t o pl ot m ulti pl e sc or es o n vis u al sc al e pr ovi d e d at t h e b ott o m of t h e 
ass ess m e nt w as r e m ov e d; t h e sc or e fr o m t h at visit will b e pl ott e d els e w h er e, a n d t h e tr aj ect ory 
of t h e sc or es will b e a n alyz e d aft er st u dy c o m pl eti o n usi n g d at a fr o m all visits.  
6. 3. 5.  Dressi n g A p plicati o n 
F oll o wi n g t h e w o u n d ass ess m e nt, t h e I nv esti g at or or ot h er cli nici a n o n t h e r es e arc h st aff will 
cl e a ns e t h e w o u n d usi n g a w o u n d cl e a nsi n g s ol uti o n a n d a p ply t h e P ur ac ol ® Ultr a P o w d er 

M e dli n e I n d u stri e s, I n c. 
 
 
Fi brill ar dr e s si n g f or tr e ati n g c hr o ni c, st all e d w o u n d s  
M E D- 2 0 1 8- DI V 7 1- 0 0 8 
 
C O N FI D E N TI A L                        
2 3 A u g u st 2 0 1 8 
V 1 . 0 
 
 
1 4  
 
dr essi n g t o t h e w o u n d. A n ot ati o n as t o t h e ty p e of s ec o n d ary dr essi n g a p pli e d will b e n ot e d o n 
t h e Dr essi n g L o g C RF (s e e A p p e n dix 1 1. 3. 4) .  
6. 4.  Dressi n g C h a n ge Visit 
P artici p a nts will visit t h e cli nic f or a dr essi n g c h a n g e t wic e w e ekly. Ulti m at e d et er mi n ati o n of 
dr essi n g c h a n g e fr e q u e ncy will r esi d e wit h t h e PI , i n t h e ev e nt t h e t wic e w e ekly visits c o nflicts wit h 
t h e p ati e nt’s cli nic al n e e ds.  D uri n g t h es e visits, p artici p a nts will b e ass ess e d f or a ny A dv ers e Ev e nts 
( A Es) a n d h av e t h eir dr essi n g c h a n g e d. D oc u m e nt ati o n of t h e dr essi n g c h a n g e will b e c a pt ur e d i n 
t h e Dr essi n g L o g C RF, av ail a bl e i n A p p e n dix 1 1. 3. 4.  
6. 5.  W o u n d Assess me nt Visit 
O n e of t h e dr essi n g c h a n g e visits will s erv e as t h e w o u n d ass ess m e nt visit as w ell. P artici p a nts will 
c o m e t o t h e cli nic ev ery 7 d ays ± 2 d ays s o t h e PI  c a n ass ess t h e w o u n d. T h e ass ess m e nts c o n d uct e d 
at t his visit will b e i d e ntic al t o t h os e d escri b e d i n S ecti o ns 6. 3. 2 t o 6. 3. 4 . A d diti o n ally, if t h e 
p artici p a nt is d u e f or a dr essi n g c h a n g e, o n e will occ ur at t his visit as w ell. All ev e nts will b e 
d oc u m e nt e d vi a t h e W o u n d P h ot o gr a p h, B W A T, a n d Dr essi n g L o g C RFs .  
6. 6.  Fi n al Visit 
T h e Fi n al Visit will t ak e pl ac e 1 2 w e eks aft er p artici p a nt e nr oll m e nt; i n t h e ev e nt t h e w o u n d 
c o m pl et ely h e als b ef or e 1 2 w e eks h av e p ass e d, t h e visit w h er e t h e PI  n ot es c o m pl et e w o u n d h e ali n g 
will s erv e as t h e Fi n al Visit. D at a c oll ecti o n will f oll o w t h e s a m e pr oc e d ur es d efi n e d i n S ecti o ns 6. 3. 1 
t o 6. 3. 4.  
7.  A D V E R S E E V E N T S  
7. 1.  Defi niti o n of A d verse E ve nt 
T h e F D A d efi niti o n f or a n A E will b e us e d i n t his st u dy: A dv ers e ev e nt m e a ns a ny u nt o w ar d m e dic al 
occ urr e nc e ass oci at e d wit h t h e us e of a n i nt erv e nti o n i n h u m a ns, w h et h er or n ot c o nsi d er e d 
i nt erv e nti o n r el at e d.  
 
7. 2.  Defi niti o n of Seri o us A d verse E ve nt 
T h e F D A d efi niti o n of a S eri o us A dv ers e Ev e nt (S A E) will b e us e d i n t his st u dy: A n A E or s us p ect e d 
a dv ers e r e acti o n is c o nsi d er e d "s eri o us" if, i n t h e vi e w of eit h er t h e PI or S p o ns or, it r es ults i n a ny of 
t h e f oll o wi n g o utc o m es:  
 
D e at h 
 
A lif e-t hr e at e ni n g a dv ers e ev e nt 
 
I n p ati e nt h os pit aliz ati o n or pr ol o n g ati o n of existi n g h os pit aliz ati o n  
 
A p ersist e nt or si g nific a nt i nc a p acity or s u bst a nti al disr u pti o n of t h e a bility t o c o n d uct 
n or m al lif e f u ncti o ns or, 
 
A c o n g e nit al a n o m aly/ birt h d ef ect.  

M e dli n e I n d u stri e s, I n c. 
 
 
Fi brill ar dr e s si n g f or tr e ati n g c hr o ni c, st all e d w o u n d s  
M E D- 2 0 1 8- DI V 7 1- 0 0 8 
 
C O N FI D E N TI A L                        
2 3 A u g u st 2 0 1 8 
V 1 . 0 
 
 
1 5  
 
I m p ort a nt m e dic al ev e nts t h at m ay n ot r es ult i n d e at h, b e lif e-t hr e at e ni n g, or r e q uir e h os pit aliz ati o n 
m ay b e c o nsi d er e d s eri o us w h e n, b as e d u p o n a p pr o pri at e m e dic al j u d g m e nt, t h ey m ay j e o p ar diz e 
t h e p artici p a nt a n d m ay r e q uir e m e dic al or s ur gic al i nt erv e nti o n t o pr ev e nt o n e of t h e o utc o m es 
list e d i n t his d efi niti o n. 
7. 3.  Se verit y of A d verse E ve nt 
 
 
Mil d:  A w ar e n ess of si g ns or sy m pt o ms, b ut e asily t ol er at e d; ar e of mi n or irrit a nt ty p e, 
c a usi n g n o l oss of ti m e fr o m n or m al activiti es; sy m pt o ms w o ul d n ot r e q uir e m e dic ati o n or a 
m e dic al ev al u ati o n; si g ns a n d sy m pt o ms ar e tr a nsi e nt. 
 
M o d er at e:  Disc o mf ort s ev er e e n o u g h t o c a us e i nt erf er e nc e wit h us u al activiti es; r e q uiri n g 
tr e at m e nt b ut n ot ext e n d e d h os pit aliz ati o n or i nt e nsiv e c ar e f or t h e s u bj ect. 
 
S e v er e:  I nc a p acit ati n g wit h i n a bility t o d o w ork or us u al activiti es; si g ns a n d sy m pt o ms m ay 
b e syst e mic i n n at ur e or r e q uir e m e dic al ev al u ati o n a n d/ or tr e at m e nt; r e q uiri n g a d diti o n al 
h os pit aliz ati o n or i nt e nsiv e c ar e ( pr ol o n g e d h os pit aliz ati o n) 
7. 4.  Rel ate d ness of A d verse E ve nt a n d Seri o us A d verse E ve nt 
 
 
U nr el at e d:  T his c at e g ory a p pli es t o t h os e a dv ers e e v e nts w hic h, aft er c ar ef ul c o nsi d er ati o n, 
ar e cl e arly a n d i nc o ntr ov erti bly d u e t o extr a n e o us c a us es ( dis e as e, e nvir o n m e nt, etc.) 
 
P ossi bl e:  T his c at e g ory a p pli es t o t h os e a dv ers e ev e nts f or w hic h, aft er c ar ef ul m e dic al 
c o nsi d er ati o n at t h e ti m e t h ey ar e ev al u at e d, a c o n n ecti o n wit h t h e I nv esti g ati o n al Pr o d uct 
a d mi nistr ati o n a p p e ars u nlik ely b ut c a n n ot b e r ul e d o ut wit h c ert ai nty. 
 
Pr o b a bl e:  T his c at e g ory a p pli es t o t h os e a dv ers e ev e nts w hic h, aft er c ar ef ul m e dic al 
c o nsi d er ati o n at t h e ti m e t h ey ar e ev al u at e d, ar e f elt wit h a hi g h d e gr e e of c ert ai nty t o b e 
r el at e d t o t h e I nv esti g ati o n al Pr o d uct. 
 
D efi nit e:  T his c at e g ory a p pli es t o t h os e a dv ers e ev e nts w hic h, aft er c ar ef ul c o nsi d er ati o n, 
ar e cl e arly a n d i nc o ntr ov erti bly d u e t o t h e I nv esti g ati o n al Pr o d uct. 
7. 5.  E x pecte d ness 
T h e PI  will b e r es p o nsi bl e f or d et er mi ni n g w h et h er a n A E or S A E is ex p ect e d or u n ex p ect e d. A n A E 
will b e c o nsi d er e d u n ex p ect e d if t h e n at ur e, s ev erity, or fr e q u e ncy of t h e ev e nt is n ot c o nsist e nt 
wit h t h e risk i nf or m ati o n pr evi o usly d escri b e d f or t h e st u dy i nt er v e nti o n.  
7. 6.  A d verse E ve nt Re p orti n g 
A Es will b e r ec or d e d o n t h e A dv ers e Ev e nt f or m ( A p p e n dix 1 1. 4) by t h e 
PI . C h a n g es i n t h e s ev erity of 
a n A E will b e d oc u m e nt e d t o all o w a n ass ess m e nt of t h e d ur ati o n of t h e ev e nt at e ac h l ev el of 
s ev erity. C h a n g es i n s ev erity will n ec essit at e a n e w C RF t o d oc u m e nt t h e n e w l ev el of s ev erity. A Es 
c h ar act eriz e d as i nt er mitt e nt r e q uir e d oc u m e nt ati o n of o ns et a n d d ur ati o n of e ac h e pis o d e. 
N o n-s eri o us A Es ar e t o b e r e p ort e d t o t h e st u dy S p o ns or o n a w e ekly b asis f or r evi e w, a n d r e p ort e d 
t o t h e I R B p er I R B r e p orti n g r e q uir e m e nts.  

M e dli n e I n d u stri e s, I n c. 
 
 
Fi brill ar dr e s si n g f or tr e ati n g c hr o ni c, st all e d w o u n d s  
M E D- 2 0 1 8- DI V 7 1- 0 0 8 
 
C O N FI D E N TI A L                        
2 3 A u g u st 2 0 1 8 
V 1 . 0 
 
 
1 6  
 
7. 7.  Seri o us A d verse E ve nt Re p orti n g 
T h e st u dy i nv esti g at or s h all c o m pl et e a n S A E F or m ( A p p e n dix 1 1. 5) a n d s u b mit t o t h e st u dy S p o ns or 
a n d t o t h e r evi e wi n g I R B as s o o n as p ossi bl e, b ut i n n o ev e nt l at er t h a n 4 8 h o urs aft er t h e 
i nv esti g at or first l e ar ns of t h e eff ect.  T h e st u dy S p o ns or is r es p o nsi bl e f or c o n d ucti n g a n ev al u ati o n 
of t h e S A E a n d s h all r e p ort t h e r es ults of s uc h ev al u ati o n t o t h e F D A a n d t o all r evi e wi n g I R Bs wit hi n 
1 0 w orki n g d ays aft er t h e S p o ns or first r ec eiv es n otic e of t h e eff ect. T h er e aft er, t h e S p o ns or s h all 
s u b mit s uc h a d diti o n al r e p orts c o nc er ni n g t h e eff ect as F D A r e q u ests. 
 
F or q uesti o ns re gar di n g t his pr ocess or t he e ve nt, y o u ma y c o ntact y o ur Me dli ne cli nical 
desi g nee or t he Me dli ne Ass ociate Direct or of Cli nical O perati o ns: 
Na me: Kara Cassa d y 
P h o ne:  8 4 7- 6 4 3 - 3 8 0 9 
E- mail:  k c a s s a d y @ m e dli n e. c o m  
8.  S T A TI S TI C A L C O N SI D E R A TI O N S 
8. 1.  S a m ple Size Deter mi n ati o n  
As t his is a n o p e n-l a b el, o bs erv ati o n al c as e s eri es, m e a nt t o ev al u at e cli nic al us e of t h e st u dy 
pr o d uct, a f or m al p o w er a n alysis w as n ot c o n d uct e d. R at h er, a s a m pl e of 
2 0  p artici p a nts w as c h os e n 
t o pr ovi d e a n i niti al esti m at e of pr o d uct p erf or m a nc e i n a cli nic al s etti n g. D at a fr o m t his st u dy m ay 
b e us e d t o p erf or m a p o w er a n alysis f or l ar g er, f ut ur e tri al.  
8. 2.  P o p ul ati o ns f or A n al yses 
A n ev al u a bl e d at as et will b e us e d t o c o n d uct all a n alys es. P artici p a nts w h o h av e at l e ast a v ali d 
w o u n d ass ess m e nt at t h eir I niti al Visit a n d t h eir Fi n al Visit, a n d c o m pli e d wit h at l e ast 
7 5 % of t h e 
dr essi n g c h a n g es, will b e i ncl u d e d i n t his d at as et.  
8. 3.  D at a A n al ysis 
8. 3. 1.  W o u n d Size A nal ysis  
D escri ptiv e st atistics f or i niti al w o u n d siz e ( m e as ur e d at t h e I niti al Visit) a n d fi n al w o u n d siz e 
( m e as ur e d at Fi n al Visit) will b e c alc ul at e d. T h es e st atistics i ncl u d e m e as ur es of c e ntr al t e n d e ncy 
( e. g. m e a n, m e di a n), v ari a bility ( e. g. st a n d ar d d evi ati o n). A 9 5 % c o nfi d e nc e i nt erv al f or m e a n 
w o u n d siz e c h a n g e will als o b e c alc ul at e d, ass u mi n g n or m ality of t h e d at a. F or ex pl or at ory 
p ur p os es, a p air e d s a m pl es t-t est will b e c o n d uct e d o n w o u n d siz e at t h e I niti al Visit vs. Fi n al 
Visit t o i d e ntify a ny si g nific a nt diff er e nc es i n w o u n d siz e ov er t h e c o urs e of t h e st u dy; if t h e d at a 
ar e n ot n or m ally distri b ut e d, a n o n- p ar a m etric t est will b e us e d. Fi n ally, c h a n g e i n w o u n d siz e 
ov er ti m e, usi n g d at a fr o m e ac h visit 
m ay b e 
m o d el e d, usi n g ot h er v ari a bl es s uc h as 
d e m o gr a p hic a n d b as eli n e d at a, t o b ett er u n d erst a n d pr e dict ors of w o u n d cl os ur e.  

M e dli n e I n d u stri e s, I n c. 
 
 
Fi brill ar dr e s si n g f or tr e ati n g c hr o ni c, st all e d w o u n d s  
M E D- 2 0 1 8- DI V 7 1- 0 0 8 
 
C O N FI D E N TI A L                        
2 3 A u g u st 2 0 1 8 
V 1 . 0 
 
 
1 7  
 
8. 3. 2.  B W A T A nal ysis 
D escri ptiv e st atistics f or B W A T sc or e fr o m t h e I niti al Visit a n d t h e Fi n al Visit will b e c alc ul at e d
. 
M e as ur es of c e ntr al t e n d e ncy a n d v ari a bility will als o b e pr ovi d e d, a n d  a p air e d s a m pl es t-t est 
c o n d uct e d o n  t h e c h a n g e i n B W A T sc or e fr o m   t h e I niti al Visit a n d Fi n al Visit will b e c alc ul at e d 
f or ex pl or at ory p ur p os es; n o n- p ar a m etric m et h o ds will b e us e d if t h e d at a ar e n ot n or m ally 
distri b ut e d. F urt h er ex pl or ati o n of t h e d at a m ay occ ur vi a m o d eli n g B W A T sc or e fr o m e ac h visit 
a n d i ncl u di n g ot h er v ari a bl es s uc h as d e m o gr a p hic a n d b as eli n e d at a t o b ett er u n d erst a n d 
pr e dict ors of w o u n d cl os ur e.   
8. 3. 3.  Pai n Scale A nal ysis 
D escri ptiv e m e as ur es of c e ntr al t e n d e ncy a n d v ari a bility will b e pr ovi d e d f or p ai n r ati n g at t h e 
I niti al Visit a n d t h e Fi n al Visit.  A 9 5 % c o nfi d e nc e i nt erv al f or m e a n c h a n g e i n p ai n will als o b e 
c alc ul at e d, ass u mi n g n or m ality of t h e d at a. F or ex pl or at ory p ur p os es,  p air e d s a m pl es t-t est will 
b e c o n d uct e d o n w o u n d siz e at t h e I niti al Visit vs. Fi n al Visit t o i d e ntify a ny si g nific a nt 
dif f er e nc es i n w o u n d siz e ov er t h e c o urs e of t h e st u dy; if t h e d at a ar e n ot n or m ally distri b ut e d, a 
n o n- p ar a m etric t est will b e us e d. T h o u g h t h es e d at a ar e t ec h nic ally o n a n or di n al sc al e, t h e t e n-
p oi nt sc al e all o ws f or t h e m e a n v al u e t o b e m or e i nf or m ativ e, a n d f or t h e p ot e nti al of 
c o n d ucti n g p ar a m etric t ests. Fi n ally, c h a n g e i n p ai n ov er ti m e m ay als o b e m o d el e d si mil arly t o 
c h a n g e i n w o u n d siz e.  
9.  S U P P O R TI N G     
D O C U M E N T A TI O N     
A N D     
O P E R A TI O N A L 
C O N SI D E R A TI O N S 
9. 1.  Ke y R oles a n d St u d y G o ver n a nce 
Pri nci p al I n vesti g at or  
E m m y Oji, D P M  
V all ey P o di atry a n d Di a b etic F o ot C e nt er  
2 5 5 0 M erc e d St.  
Fr es n o, C A 9 3 7 2 1  
5 5 9 -2 5 6 -9 6 0 0  
N a m e  
Titl e  
Affili ati o n  
R es p o nsi bilit y  
Willi a m 
J ac o bs o n, 
P h D  
Cli nic al Aff airs Dir ect or  
M e dli n e I n d ustri es, I nc.  
 Li ais o n wit h I nv esti g at ors  
 I n p ut o n st u dy d esi g n  
 I nt er pr et ati o n of r es ults  
 G e n er al    
cli nic al    
a n d 
sci e ntific ov ersi g ht of st u dy 
c o n d uct  
Ji m M o nti, P h D 
S e ni or M e dic al Writ er  
M e dli n e I n d ustri es, I nc.  
  A ut h ori n g st u dy pr ot oc ol  
  A ut h ori n g 
fi n al  
Cli nic al 
St u dy R e p ort  
  D at a a n alysis  
St e p h a ni e 
M arty n e nk o  
Cli nic al R es e arc h Ass oci at e 
I 
M e dli n e I n d ustri es, I nc.  
 St u dy m o nit ori n g activiti es  

M e dli n e I n d u stri e s, I n c. 
 
 
Fi brill ar dr e s si n g f or tr e ati n g c hr o ni c, st all e d w o u n d s  
M E D- 2 0 1 8- DI V 7 1- 0 0 8 
 
C O N FI D E N TI A L                        
2 3 A u g u st 2 0 1 8 
V 1 . 0 
 
 
1 8  
 
 
9. 2.  Cli nic al M o nit ori n g 
T h e Cli nic al R es e arc h Ass oci at e ( C R A) will c o nfir m t h at t h e ri g hts a n d w ell- b ei n g of s u bj ects ar e 
pr ot ect e d, a n d t h at t h e r e p ort e d tri al d at a ar e acc ur at e, c o m pl et e, a n d v erifi a bl e fr o m s o urc e 
d oc u m e nts. M or e ov er, t h e C R A will c o nfir m t h e c o n d uct of t h e tri al by t h e 
PI  a n d sit e is i n 
c o m pli a nc e wit h t h e pr ot oc ol, G C P, a n d r e g ul at ory r e q uir e m e nts as w ell as a ny a p plic a bl e 
i nstit uti o n or I R B a n d f e d er al or l oc al pr oc ess es. M o nit ori n g will occ ur at mi ni m u m ev ery t w o 
m o nt hs d uri n g t h e st u dy d ur ati o n or m or e fr e q u e ntly if: 
 
T h e v ol u m e or q u ality of d at a is l ar g e or t h er e is a b ackl o g of r evi e w d u e t o 
u n ex p ect e d iss u es 
 
T his w o ul d als o i ncl u d e a ny l ar g e v ol u m e of C RFs t o b e r evi e w e d  
 
T h e sit e c o m pli a nc e wit h t h e pr ot oc ol or c o m pli a nc e wit h ex p ect e d I C H/ G C P a n d 
r e g ul at ory r e q uir e m e nts is l acki n g or t h er e ar e c o nti n ui n g u nr es olv e d c o m pli a nc e 
iss u es 
 
T h er e ar e u n ex p ect e d A E/S A E or s u bj ect s af ety c o nc er ns n ot e d  
 
T h er e ar e a ny u n ex p ect e d i nc o nsist e nci es wit h st u dy pr o d uct m a n a g e m e nt 
 
T h er e is a r e q u est f or m or e fr e q u e nt m o nit ori n g by t h e sit e 
 
A ny m ut u ally a gr e e a bl e sit u ati o n as d et er mi n e d by t h e sit es a n d M e dli n e  
T h e fr e q u e ncy of r o uti n e m o nit ori n g m ay b e i ncr e as e d t o a l o n g er i nt erv al aft er t hr e e m o nit ori n g 
cycl es if o n-sit e sit u ati o ns s u p p ort t his c h a n g e. C R A will disc uss t his wit h M e dli n e Ass oci at e 
Dir ect or or Cli nic al M a n a g er a n d will i nf or m t h e PI  pri or t o i m pl e m e nt ati o n.  
M o nit ori n g activiti es 
will i ncl u d e s u bj ect eli gi bility, s o urc e d at a r evi e w, C RF c o m pl eti o n 
v erific ati o n, pr o d uct acc o u nt a bility, sit e c o nti n u e d s uit a bility, PI st u dy ov ersi g ht, c o m pli a nc e, a n d 
all g e n er al m o nit ori n g activiti es as o utli n e d i n F D As C o d e of F e d er al R e g ul ati o ns a n d I C H/ G C P 
g ui d eli n es t h at g ui d e t h at activity.   
M e dli n e I n d ustri es I nc. m a y, o n occ asi o n, c o ntr act wit h ext er n al C R Os t o pr ovi d e C R A s ervic es a n d 
t h os e C R As ar e a ut h oriz e d t o act o n b e h alf of M e dli n e I n d ustri es, I nc .  
It is ex p ect e d t h at t h e sit e will b e c o m pli a nt wit h a ny i nstit uti o n al S O Ps d uri n g t h e ex ec uti o n of 
t h e pr ot oc ol a n d evi d e nc e of t h at c o m pli a nc e s h o ul d b e r e a dily d oc u m e nt e d a n d v erifi a bl e by t h e 
C R A.  
T h e C R A will g e n er at e a n i nt er n al M e dli n e I n d ustri es I nc. visit r e p ort t h at will b e fil e d wit h t h e 
M e dli n e I n d ustri es, I nc. tri al m ast er fil e a n d will pr ovi d e t h e PI a d et ail e d f oll o w- u p l ett er aft er 
e ac h m o nit ori n g visit t h at will o utli n e t h e c o m pl et e d m o nit ori n g activiti es as w ell as a ny i d e ntifi e d 
ar e as of c o nc er n a n d t h e ex p ect e d/ a p plic a bl e c orr ecti o ns n e e d e d. 
M e dli n e I n d ustri es I nc., 
r es erv es t h e ri g ht t o p erf or m a u dit of t h e st u dy activiti es –  eit h er r o uti n e or f or-c a us e –  as 
n e e d e d, a n d m ay als o p erf or m cli nic al m o nit ori n g a u dit as w ell. 
 

M e dli n e I n d u stri e s, I n c. 
 
 
Fi brill ar dr e s si n g f or tr e ati n g c hr o ni c, st all e d w o u n d s  
M E D- 2 0 1 8- DI V 7 1- 0 0 8 
 
C O N FI D E N TI A L                        
2 3 A u g u st 2 0 1 8 
V 1 . 0 
 
 
1 9  
 
9. 3.  Re g ul at or y a n d Et hic al C o nsi der ati o ns 
9. 3. 1.  C o nfi de ntialit y a n d Pri vac y 
P artici p a nt c o nfi d e nti ality a n d priv acy is strictly h el d i n tr ust by t h e PI, his or h er st aff, a n d t h e 
S p o ns or. T his c o nfi d e nti ality is ext e n d e d t o c ov er t esti n g of bi ol o gic al s a m pl es i n a d diti o n t o t h e 
cli nic al i nf or m ati o n r el ati n g t o p artici p a nts. T h er ef or e, d oc u m e nt ati o n, d at a, a n d all ot h er 
i nf or m ati o n g e n er at e d will b e h el d i n strict c o nfi d e nc e. N o i nf or m ati o n c o nc er ni n g t h e st u dy or 
t h e d at a will b e r el e as e d t o a ny u n a ut h oriz e d t hir d p arty wit h o ut pri or writt e n a p pr ov al of t h e 
S p o ns or. All st u dy d at a a n d st u dy r ec or ds will b e m a n a g e d a n d st or e d i n acc or d a nc e wit h t h e 
sit e’s HI P A A c o m pli a nt p olici es o n d at a st or a g e a n d s ec urity. All el ectr o nic tr a ns missi o n of d at a 
will a d h er e t o HI P A A S ec urity R ul es. 
 
T h e st u dy m o nit or, ot h er a ut h oriz e d r e pr es e nt ativ es of t h e S p o ns or, r e pr es e nt ativ es of t h e I R B 
a n d r e g ul at ory a g e nci es m ay i ns p ect all d oc u m e nts a n d r ec or ds r e q uir e d t o b e m ai nt ai n e d by 
t h e PI, i ncl u di n g b ut n ot li mit e d t o, m e dic al r ec or ds ( offic e, cli nic, or h os pit al) a n d p h ar m acy 
r ec or ds f or t h e p artici p a nts i n t his st u dy. T h e cli nic al st u dy sit e will p er mit acc ess t o s uc h 
r ec or ds. 
 
A m ast er list li nki n g s u bj ect n u m b ers t o p ati e nt n a m e a n d m e dic al r ec or d n u m b er will b e 
m ai nt ai n e d i n a s ec ur e d at a b as e by t h e PI. 
T h e st u dy p artici p a nt’s c o nt act i nf or m ati o n will b e 
s ec ur ely st or e d at e ac h cli nic al sit e f or i nt er n al us e d uri n g t h e st u dy. At t h e e n d of t h e st u dy, all 
r ec or ds will c o nti n u e t o b e k e pt i n a s ec ur e l oc ati o n f or at l e ast a p eri o d of t w o y e ars, or l o n g er 
if dict at e d by t h e r evi e wi n g I R B, I nstit uti o n al p olici es, S p o ns or r e q uir e m e nts, or I C H/ G C P a n d 
F D A r e q uir e m e nts.  T h e PI  will a gr e e t o n otify S p o ns or of a ny i nt e nt t o m ov e or d estr oy t h es e 
d oc u m e nts.  
 
St u dy p artici p a nt r es e arc h d at a, w hic h is f or p ur p os es of st atistic al a n alysis a n d sci e ntific 
r e p orti n g, will b e m ai nt ai n e d at t h e r es e arc h sit es o n t h e C RFs. C o pi es of t h e C RFs, w hic h will 
n ot c o nt ai n a ny i d e ntifi a bl e i nf or m ati o n, will b e pr ovi d e d t o t h e S p o ns or f or t h e p ur p os es of 
d at a a n alysis.  T h e st u dy d at a e ntry a n d st u dy m a n a g e m e nt syst e ms us e d by cli nic al sit es a n d by 
M e dli n e I n d ustri es, I nc. r es e arc h st aff will b e s ec ur e d a n d st or e d i n a n acc ess c o ntr oll e d l ock e d 
dr a w er ( a ny p a p er f or ms) a n d p ass w or d pr ot ect e d ( el ectr o nic r ec or ds). At t h e e n d of t h e st u dy, 
all st u dy d at a b as es t h at ar e n ot alr e a dy d e-i d e ntifi e d will b e d e-i d e ntifi e d a n d arc hiv e d at 
M e dli n e I n d ustri es, I nc. 
9. 3. 2.  Sa fet y O versi g ht 
Giv e n t h at t his is a p ost- m ark et st u dy o n a d evic e us e d i n acc or d a nc e wit h its l a b eli n g, t h er e is 
mi ni m al s af ety risk t o p artici p a nts. T h e PI is a d oct or of p o di atric m e dici n e a n d tr ai n e d i n 
tr e ati n g t h es e ty p es of w o u n ds. I n t h e ev e nt t h er e a ny A Es or S A Es, t h e PI will r evi e w t h e m a ny 
m ak e a ny n ec ess ary s af ety d et er mi n ati o ns as n e e d e d.  
9. 3. 3.  Data Ha n dli n g a n d Rec or d Kee pi n g 
 

M e dli n e I n d u stri e s, I n c. 
 
 
Fi brill ar dr e s si n g f or tr e ati n g c hr o ni c, st all e d w o u n d s  
M E D- 2 0 1 8- DI V 7 1- 0 0 8 
 
C O N FI D E N TI A L                        
2 3 A u g u st 2 0 1 8 
V 1 . 0 
 
 
2 0  
 
D at a c oll ecti o n is t h e r es p o nsi bility of t h e cli nic al tri al st aff at t h e sit e u n d er t h e s u p ervisi o n of 
t h e PI . T h e i nv esti g at or is r es p o nsi bl e f or e ns uri n g t h e acc ur acy, c o m pl et e n ess, l e gi bility, a n d 
ti m eli n ess of t h e d at a r e p ort e d. 
 
All s o urc e d oc u m e nts of a ny ki n d ( el ectr o nic, p a p er, etc.) s h o ul d b e c o m pl et e d i n acc or d a nc e 
wit h G o o d D oc u m e nt ati o n Pr actic es ( G D P) t o e ns ur e acc ur at e i nt er pr et ati o n of d at a.  C R Fs will 
b e cr e at e d f or e ac h s u bj ect. T h e C R A will v erify t h e d at a e nt er e d i nt o t h e C RF wit h t h e sit e 
s o urc e r e g ar dl ess of t h e ty p e of s o urc e. T h e sit e will b e r es p o nsi bl e f or d ev el o pi n g a writt e n 
pr oc ess t h at e ns ur es t h e C R A is a bl e vi e w t h e s o urc e d at a.    
 
D at a fr o m t h e C RFs will b e e nt er e d i nt o a n el ectr o nic s pr e a ds h e et vi a d u al- e ntry t o ass ur e n o 
err ors. D at a will b e tr a nsf err e d t o a n d a n alyz e d wit h S AS f or st atistic al a n alysis. S AS all o ws f or 
i nt er n al q u ality c h ecks, s uc h as a ut o m atic r a n g e c h ecks, t o i d e ntify d at a t h at a p p e ar 
i nc o nsist e nt, i nc o m pl et e, or i n acc ur at e. 
M e dli n e I n d ustri es, I nc. 
will b e r es p o nsi bl e f or 
ov ers e ei n g fi n al d at a a n alysis a n d c o nfir m ati o n of r es ults.  
9. 3. 4.  St u d y Rec or ds Rete nti o n  
 
St u dy d oc u m e nts s h o ul d b e r et ai n e d u ntil at l e ast t w o y e ars h av e el a ps e d si nc e t h e f or m al 
disc o nti n u ati o n of t h e st u dy i nt erv e nti o n or as r e q uir e d by a ny a p plic a bl e F D A g ui d eli n es or f or 
a l o n g er p eri o d if r e q uir e d by l oc al r e g ul ati o ns. N o r ec or ds will b e d estr oy e d wit h o ut t h e writt e n 
c o ns e nt of t h e S p o ns or, if a p plic a bl e. It is t h e r es p o nsi bility of t h e S p o ns or t o i nf or m t h e PI w h e n 
t h es e d oc u m e nts n o l o n g er n e e d t o b e r et ai n e d. T h e PI  is r e q uir e d t o n otify M e dli n e if t h e 
l oc ati o n of t h e st or e d d oc u m e nts is c h a n g e d aft er it is d efi n e d at t h e ti m e of t h e Cl os e O ut Visit 
at st u dy e n d.  
9. 3. 5.  St u d y Disc o nti n uati o n  
T his st u dy m ay b e t e m p or arily s us p e n d e d or pr e m at ur ely t er mi n at e d if t h er e is s uffici e nt 
r e as o n a bl e c a us e.  
Writt e n n otific ati o n, d oc u m e nti n g t h e r e as o n f or st u dy s us p e nsi o n or 
t er mi n ati o n, will b e pr ovi d e d by t h e s us p e n di n g or t er mi n ati n g p arty t o t h e PI, S p o ns or, a n d I R B.  
If t h e st u dy is pr e m at ur ely t er mi n at e d or s us p e n d e d, t h e PI  will pr o m ptly i nf or m t h e I R B a n d 
S p o ns or a n d will pr ovi d e t h e r e as o n(s) f or t h e t er mi n ati o n or s us p e nsi o n.   
Circ u mst a nc es t h at m ay w arr a nt t er mi n ati o n or s us p e nsi o n i ncl u d e, b ut ar e n ot li mit e d t o: 
 
D et er mi n ati o n of u n ex p ect e d, si g nific a nt, or u n acc e pt a bl e ris k t o p artici p a nts as 
d et er mi n e d by A E  r evi e w 
 
I ns uffici e nt c o m pli a nc e t o pr ot oc ol r e q uir e m e nts 
 
D at a t h at ar e n ot s uffici e ntly c o m pl et e a n d/ or ev al u a bl e 
T h e st u dy m ay r es u m e o nc e c o nc er ns a b o ut s af ety, pr ot oc ol c o m pli a nc e, a n d d at a q u ality ar e 
a d dr ess e d, a n d s atisfy t h e S p o ns or a n d/ or I R B. 
9. 3. 6.  St u d y Cl ose o ut  
U p o n c o m pl eti o n of t h e st u dy, M e dli n e a n d/ or its d esi g n e es will n otify t h e sit e of cl os e o ut 
r el at e d pr oc e d ur es a n d will c o or di n at e wit h t h e sit e t h e r et ur n of e q ui p m e nt a n d/ or a ny u n us e d 

M e dli n e I n d u stri e s, I n c. 
 
 
Fi brill ar dr e s si n g f or tr e ati n g c hr o ni c, st all e d w o u n d s  
M E D- 2 0 1 8- DI V 7 1- 0 0 8 
 
C O N FI D E N TI A L                        
2 3 A u g u st 2 0 1 8 
V 1 . 0 
 
 
2 1  
 
pr o d uct.  M e dli n e C R A will c o m m u nic at e cl os ely wit h t h e PI  at t h at ti m e p oi nt a n d will r evi e w all 
cl os e o ut st e ps a n d m at eri als. All st u dy d at a, r el at e d st u dy d oc u m e nts, a n d u n us e d st u dy 
pr o d uct, will b e r et ur n e d t o t h e S p o ns or.  S p o ns or will pr ovi d e t h e f acility wit h a s u m m ary of t h e 
activiti es a n d fi n di n gs aft er t h e fi n al a n alysis of t h e d at a h as b e e n c o m pl et e d. T h e sit e will als o 
n otify t h e I R B t h at t h e st u dy h as c o m pl et e d. 
9. 3. 7.  C o nflict of I nterest P olic y 
T h e i n d e p e n d e nc e of t his st u dy fr o m a ny act u al or p erc eiv e d i nfl u e nc e is critic al. T h er ef or e, a ny 
act u al c o nflict of i nt er est of p ers o ns w h o h av e a r ol e i n t h e d esi g n, c o n d uct, a n alysis, p u blic ati o n 
or a ny as p ect of t his tri al will b e discl os e d a n d m a n a g e d . 
9. 4.  Pr ot oc ol De vi ati o ns 
It is t h e r es p o nsi bility of t h e PI  a n d st u dy st aff t o us e c o nti n u o us vi gil a nc e t o i d e ntif y a n d r e p ort 
d evi ati o ns o n a r o uti n e b asis. All d evi ati o ns m ust b e a d dr ess e d i n st u dy s o urc e d oc u m e nts, a n d 
r e p ort e d t o M e dli n e I n d ustri es, I nc. Pr ot oc ol d evi ati o ns m ust b e s e nt t o t h e r evi e wi n g I R B p er 
t h eir p olici es. T h e sit e i nv esti g at or is r es p o nsi bl e f or k n o wi n g a n d a d h eri n g t o t h e r evi e wi n g I R B 
r e q uir e m e nts 
9. 5.  A b bre vi ati o ns a n d Ter ms 
A E  
B W A T  
A dv ers e Ev e nt  
B at es -J e ns e n W o u n d Ass ess m e nt T o ol  
CF R  
C o d e of F e d er al R e g ul ati o ns  
C R A  
Cli nic al R es e arc h Ass oci at e  
C R F  
C as e R e p ort F or m  
D P M  
D oct or of P o di atric M e dici n e  
G C P  
G o o d Cli nic al Pr actic e  
G D P  
G o o d D oc u m e nt ati o n Pr actic e  
I C H 
I nt er n ati o n al C o nf er e nc e o n H ar m o niz ati o n  
IF U 
I nstr ucti o ns f or Us e 
I R B 
I nstit uti o n al R evi e w B o ar d  
PI  
P ri nci p al I nv esti g at or 
 

M e dli n e I n d u stri e s, I n c. 
 
 
Fi brill ar dr e s si n g f or tr e ati n g c hr o ni c, st all e d w o u n d s  
M E D- 2 0 1 8- DI V 7 1- 0 0 8 
 
C O N FI D E N TI A L                        
2 3 A u g u st 2 0 1 8 
V 1 . 0 
 
 
2 2  
 
1 0.  R E F E R E N C E S 
1.  B er g a n JJ, Sc h mi d- Sc h o n b ei n G W, C ol eri d g e S mit h P D, Nic ol ai d es A N, B oiss e a u M R, Ekl of B. 
M ec h a nis ms of dis e as e: c hr o nic v e n o us dis e as e. 
N E n gl J M e d . 2 0 0 6; 3 5 5: 4 8 8- 9 8. 
2.  S h a h S V, C h akr av art hy, D. Ev al u ati o n of a b ovi n e 1 0 0 % n ativ e c oll a g e n f or t h e tr e at m e nt of 
c hr o nic w o u n ds: A c as e s eri es. J W o u n d Ost o my C o nti n e nc e N urs . 2 0 1 5 M ay-J u n; 4 2( 3): 2 2 6- 3 4.  
3.  H errick S E, Ir el a n d G W, Si m o n D, Mc C oll u m C N, F er g us o n M W. V e n o us ulc er fi br o bl asts 
c o m p ar e d wit h n or m al fi br o bl asts s h o w diff er e nc es i n c oll a g e n b ut n ot fi br o n ecti n pr o d ucti o n 
u n d er b ot h n or m al a n d hy p oxic c o n diti o ns. J I nv est D er m at ol.  1 9 9 6; 1 0 6: 1 8 7- 9 3.  
4.  F al a n g a V. C hr o nic w o u n ds: p at h o p hysi ol o gic a n d ex p eri m e nt al c o nsi d er ati o ns. J I nv est 
D er m at ol.  1 9 9 3; 1 0 0: 7 2 1- 2 5. 

M e dli n e I n d u stri e s, I n c. 
 
 
Fi brill ar dr e s si n g f or tr e ati n g c hr o ni c, st all e d w o u n d s  
M E D- 2 0 1 8- DI V 7 1- 0 0 8 
 
C O N FI D E N TI A L                        
2 3 A u g u st 2 0 1 8 
V 1 . 0 
 
 
2 3  
 
1 1.  A P P E N DI X 
1 1. 1.  
Pr o d ucts use d i n st u d y 
1 1. 1. 1.  I n vesti gati o nal Pr o d uct: P urac ol ® Ultra P o w der La bel a n d I nstr ucti o ns f or Use 
 
 
 

M e dli n e I n d u stri e s, I n c. 
 
 
Fi brill ar dr e s si n g f or tr e ati n g c hr o ni c, st all e d w o u n d s  
M E D- 2 0 1 8- DI V 7 1- 0 0 8 
 
C O N FI D E N TI A L                        
2 3 A u g u st 2 0 1 8 
V 1 . 0 
 
 
2 4  
 
 
 
 

M e dli n e I n d u stri e s, I n c. 
 
 
Fi brill ar dr e s si n g f or tr e ati n g c hr o ni c, st all e d w o u n d s  
M E D- 2 0 1 8- DI V 7 1- 0 0 8 
 
C O N FI D E N TI A L                        
2 3 A u g u st 2 0 1 8 
V 1 . 0 
 
 
2 5  
 
1 1. 1. 2.  O ptif oa m ®  Ge ntle Silic o ne B or der Dressi n gs 
O ptif o a m G e ntl e silic o n e b or d er dr essi n gs ar e c urr e ntly m ark et e d dr essi n gs i n dic at e d f or t h e m a n a g e m e nt of p arti al a n d s h all o w f ull-t hick n ess w o u n ds. 
T h e dr essi n gs ai d i n pr ovi di n g a m oist w o u n d e nvir o n m e nt a n d t h e a bs or pti o n of ex u d at e, w hic h ai ds i n w o u n d h e ali n g. T h e silic o n e a d h esiv e is oft e n 
l ess tr a u m atic a n d p ai nf ul u p o n r e m ov al c o m p ar e d t o acrylic b as e d a d h esiv es. T h e dr essi n gs t h at will b e us e d i n t his st u dy ar e av ail a bl e i n f o ur siz es: 
1/ 6” × 2”, 3”  × 3”, 4” × 4”, a n d 6” × 6”.  
 
 

M e dli n e I n d u stri e s, I n c. 
 
 
Fi brill ar dr e s si n g f or tr e ati n g c hr o ni c, st all e d w o u n d s  
M E D- 2 0 1 8- DI V 7 1- 0 0 8 
 
C O N FI D E N TI A L                        
2 3 A u g u st 2 0 1 8 
V 1 . 0 
 
 
2 6  
 
 
1 1. 1. 3.  C o Fle x ® T L C T w o La yer C o m pressi o n Ba n da ge S yste m 
C o Fl ex TL C t w o-l ay er c o m pr essi o n b a n d a g e syst e m is a c o m pr essiv e dr essi n g syst e m i nt e n d e d f or us e t o m a n a g e v e n o us dis e as e. T h e first l ay er of t h e 
dr essi n g is a s oft f o a m t h at wicks a w ay m oist ur e, wit h t h e s ec o n d l ay er c o m p os e d of a s h ort str etc h c o h esiv e m at eri al, pr ovi di n g a d a ptiv e c o m pr essi o n 
l ev els. T h e d evic e als o c o m es wit h a nyl o n st ocki n g t o a p ply ov er t h e c o m pl et e d dr essi n g f or p ati e nt c o mf ort a n d e as e of m ov e m e nt u n d er cl ot h es a n d 
o n b e d s h e ets. F urt h er i nf or m ati o n r e g ar di n g t h e d evic e c a n b e f o u n d b el o w or at htt ps:// w w w. m e dli n e.c o m/ pr o d uct/ C o
Fl ex - TL C- T w o-L ay er-
C o m pr essi o n-Syst e m/ M ulti-L ay er- C o m pr essi o n-Syst e ms/ Z 0 5- PF 1 1 4 8 2 ? q u esti o n =c ofl ex +tlc &i n d ex = P 1 &i n d ex C o u nt = 1 
 

M e dli n e I n d u stri e s, I n c. 
 
 
Fi brill ar dr e s si n g f or tr e ati n g c hr o ni c, st all e d w o u n d s  
M E D- 2 0 1 8- DI V 7 1- 0 0 8 
 
C O N FI D E N TI A L                        
2 3 A u g u st 2 0 1 8 
V 1 . 0 
 
 
2 7  
 
1 1. 2.  
Scree ni n g F or ms 
1 1. 2. 1.  Pre- Scree ni n g F or m 
Pre -Scree ni n g F or m  
 
M E D -2 0 1 8 -DI V 7 1 -0 0 8: A case series e val uati n g a fi brillar c olla ge n p o w der dressi n g t o treat 
chr o nic, stalle d l o wer -e xtre mit y w o u n ds  
Scree ni n g  #:  
Criteri a  
A ge: _ _ _ _ _ _ _ _ _ _ _      
  Bet wee n >  1 8  
W here is y o ur w o u n d l
ocate d? _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
M ust be bel o w k nee  
H o w l o n g has t he w o u n d bee n prese nt? _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
M ust be >  4 wee ks  
 
Ha ve y o u trie d a n y t hera pies t o heal t he w o u n d? If s o, w hat were t he y?
 
 
 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
 
M ust ha ve trie d at least o ne 
t y pe of a d va nce d w o u n d 
dressi n g/t hera p y  
W o ul d y o u be a ble t o visit t he cli nic 
t wice a wee k f or u p t o 1 2 wee ks? 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
M ust a ns wer yes  
 
 
T his s u bject is:   C o nti n ui n g i n t he st u d y ☐            Dis misse d fr o m t he st u d y ☐             
 
If s u bject is dis misse d, please d oc u me nt reas o n: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
F or m c o m plete d b y: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _      Date: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
 
 
 
 
 

M e dli n e I n d u stri e s, I n c. 
 
 
Fi brill ar dr e s si n g f or tr e ati n g c hr o ni c, st all e d w o u n d s  
M E D- 2 0 1 8- DI V 7 1- 0 0 8 
 
C O N FI D E N TI A L                        
2 3 A u g u st 2 0 1 8 
V 1 . 0 
 
 
2 8  
 
1 1. 2. 2.  Scree ni n g F or m 
Scree ni n g F or m  
M E D -2 0 1 8 -DI V 7 1 -0 0 8: A case series e val uati n g a fi brillar c olla ge n p o w der dressi n g t o treat c hr o nic, 
stalle d l o wer -e xtre mit y w o u n ds  
S u bject #:  _ _ _ _ _ _ _ _ _ _  
A ge: _ _ _ _ _ _ _ _ _  
Ge n der ( please c hec k o n):                ☐  Male                 ☐ Fe male  
Yes           N o  
E xcl usi o n Criteri a  
1.  D oes t he s u bject ha ve a k n o w n se nsiti vit y t o c olla ge n?
 
☐            ☐ 
2.  Is t he s u bject pre g na nt,  breast fee di n g, or i nte n di n g t o bec o me pre g na nt d uri n g t he 
d urati o n of t he st u d y?  
☐            ☐ 
3.  D oes patie nt ha ve oste o m yelitis or  a n i nfecti o n i n t he w o u n d?  
☐            ☐ 
4.  Is t he s u bject u n willi n g  or u na ble  t o a p pl y a p orci ne base d pr o d uct t o t he w o u n d?  
☐            ☐ 
I ncl usi o n Criteri a  
5.  Is t he w o u n d l ocate d bel o w t he k nee?  
☐            ☐ 
6.  Is t he c hr o nic w o u n d bet wee n 1 c m 2 t o 1 0 0 c m2 
☐            ☐ 
7.  Is t he s u bject’s w o u n d d urati o n greater t ha n or e q ual t o f o ur wee ks?  
☐            ☐ 
8.  Is t he w o u n d a press ure ulcer, dia betic f o ot ulcer, ve n o us ulcer, ulcer of mi xe d -
vasc ular ori gi n, p ost -s ur gical, or tra u matic w o u n d   (circle w o u n d t y pe)  
☐            ☐ 
9.  Has t he s u bject trie d a n a d va nce d w o u n d dressi n g or t hera p y t o treat t he
 
      w o u n d wit h o ut s uccess? If yes, list 
bel o w: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
☐            ☐ 
1 0.  Bi p hasic or tri p hasic D o p pler wa vef or m, or A n kle Brac hial I n de x > 0. 8 wit h n o 
w orse t ha n mil d disease o n se g me ntal press ures, ta ke n
 wit hi n last 3 m o nt hs  
☐            ☐ 
T o q u alif y f or st u d y, s u bject m ust :  
 
be  > 1 8 years ol d  
 
Ha ve a “ N o” res p o nse f or q u esti o ns 1 -4  
 
Ha ve a “ Yes” res p o nse f or q uesti o ns 5 -9  
T his s u bject is:   C o nti n ui n g i n t he st u d y ☐            Dis misse d fr o m t he st u d y ☐             
If s u bject is dis misse d, please d oc u me nt reas o n: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
 
F or m c o m plete d b y: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _      Date: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
 

M e dli n e I n d u stri e s, I n c. 
 
 
Fi brill ar dr e s si n g f or tr e ati n g c hr o ni c, st all e d w o u n d s  
M E D- 2 0 1 8- DI V 7 1- 0 0 8 
 
C O N FI D E N TI A L                        
2 3 A u g u st 2 0 1 8 
V 1 . 0 
 
 
2 9  
 
1 1. 3.  
C ase Re p ort F or ms 
1 1. 3. 1.  I nitial Visit Case Re p ort F or m 
I niti al Visit C ase Re p ort F or m  
 
M E D -2 0 1 8 -DI V 7 1 -0 0 8: A case series e val uati n g a fi brillar c olla ge n p o w der dressi n g t o treat 
c hr o nic, stalle d l o wer -e xtre mit y w o u n ds  
De m o gr a p hic D at a  
S u bject N u m ber:    
A ge:  
Ge n der:  M al e   F e m al e  
Hei g ht (i n):  
Wei g ht ( l bs):  
 
R ace ( ma y select m ore t ha n o ne): Blac k 
 
Rele v a nt Me dic al Di a g n oses  a n d C urre nt Me dic ati o ns :  
 
 
 
W o u n d Hist or y  
W o u n d T y pe:
 
 
W o u n d L oc ati o n:
 
 
D ur ati o n of w o u n d (i n m o nt hs):  
Pri or tre at me nts a n d d ur ati o n:  
 
 
 
 
 
 
H as mec h a nic al de bri de me nt bee n perf or me d ?  
Yes  
N o   
F or m C o m plete d b y:  
D ate:  

M e dli n e I n d u stri e s, I n c. 
 
 
Fi brill ar dr e s si n g f or tr e ati n g c hr o ni c, st all e d w o u n d s  
M E D- 2 0 1 8- DI V 7 1- 0 0 8 
 
C O N FI D E N TI A L                        
2 3 A u g u st 2 0 1 8 
V 1 . 0 
 
 
3 0  
 
1 1. 3. 2.  W o u n d P h ot o Case Re p ort F or m 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
W o u n d P h ot o C ase Re p ort F or m
 
M E D -2 0 1 8 -DI V 7 1 -0 0 8: A case series e val uati n g a fi brillar c olla ge n p o w der dressi n g t o treat 
c hr o nic, stalle d l o wer -e xtre mit y w o u n ds  
Pl a c e p h ot o gr a p h of t h e w o u n d b el o w:  
S u bj e ct N u m b er : _ _ _ _ _ _ _ _ _   D at e: _ _ _ _ _ _ _ _ _ _ _   W o u n d A s s e s s m e nt N u m b er:
 _ _ _ _ _ _ _ _ _    
W o u n d Si z e: _ _ _ _ _ _ _ _ 
c m 2  ( e nt er v al u e o bt ai n e d fr o m c a m er a s oft w ar e pl atf or m ) 
C urr e nt P ai n R ati n g: _ _ _ _ _ _ _ _ _                    Dr e s si n g C h a n g e P ai n R ati n g: _ _ _ _ _ _ _ _ _
 
 

M e dli n e I n d u stri e s, I n c. 
 
 
Fi brill ar dr e s si n g f or tr e ati n g c hr o ni c, st all e d w o u n d s  
M E D- 2 0 1 8- DI V 7 1- 0 0 8 
 
C O N FI D E N TI A L                        
2 3 A u g u st 2 0 1 8 
V 1 . 0 
 
 
3 1  
 
1 1. 3. 3.  Bates-Je nse n W o u n d Assess me nt T o ol ( B W A T) 
1 1. 3. 3. 1.  B W A T I nstr ucti o ns f or use 
 
Ge neral G ui de lines: 
 
Fill o ut t he a ttache d ratin g s heet t o assess a w o u n d’s stat us after rea di n g t he de fi niti o ns a n d met ho d s of assessme nt  de scribe d be l o w. 
E val uate o nce a w eek a n d whe ne ver a c ha n ge occ urs i n t he wo u n d. Rate acc or di n g t o eac h ite m b y  pic ki n g t he resp o ns e t hat be st 
de scribe s t he wou n d a n d e nt eri n g t hat sc ore i n t he ite m sc ore c ol u mn f or t he a p pr o priate  da te. 
W he n yo u ha ve rate d t he wou n d o n all 
ite ms, de ter mi ne t he t otal sc ore b y a d d i n g t o gether t he 1 3- ite m sc ores. T he  HI G H E R t he t o tal scor e, t he mor e se vere t he wo u n d stat us . 
Pl ot t o tal scor e o n t he W o u n d Stat us C o n tin u u m t o  de ter mi ne pr o g ress. If t he wou n d has h eale d /res ol ve d, sc ore ite ms 1, 2, 3 a n d 4 as = 0 . 
 
S pecif ic Ins tr ucti ons : 
1.  
Size : Use r uler t o meas ure t he l on g est a n d wi dest as p ect of t he wou n d s urface i n cen timeters; mu ltipl y len g t h x wi dt h. Sc ore 
as = 0 if wo u n d h eale d/res ol ve d. 
 
2.  
De pt h : Pick t he de pt h, t h ick n ess, most ap pr o pr iate t o t he wou n d us i n g t hese ad d iti o nal descri ptio ns, sc ore as 
0 = 
   if wou n d h eale d/res ol ve d: 
1 =        tiss ues da ma ge d b ut n o br eak i n s ki n s urface. 
2 =        s uperficial, a brasi o n, b lister or s hallo w crat er. E ve n with, &/ or ele vate d a b o ve s ki n s urface (e. g.,  h yper plasi a). 
3 =        d eep crater w ith or w ith o ut u n der mi ni n g of a dj acent tiss ue. 4 =        
vi s ualizati o n of tiss ue layers n ot p o ssi ble d ue t o necr osis.   5 =        s up p or tin g 
str uctures i n clu de ten d o n, j oi nt cap s ule. 
 
3.  
E d ges : Sc ore as = 0 if w ou n d h eale d/res ol ve d. Use t his g u i de: 
 
In d istin ct, d iff use 
=  
u n ab le to  clearly  d istin g u ish  w o u n d  o u tlin e. 
A ttach e d 
=  
ev en  o r flus h  w ith  w o u n d  b ase, n o  sid es o r w alls pr esen t; flat. 
N o t attach e d 
=  
sid es o r w alls are pr esen t; flo o r o r b ase o f w o u n d  is d eep er th an  ed g e. 
R o lled  u n d er, th ick en ed  
=  
so ft to  firm  an d  flex ib le to  to u ch . 
H y per k era to sis 
=  
callo us -lik e tiss ue for m atio n  ar ou n d  w o u n d  &  at ed g es. 
Fi br o tic, scarre d  
=  
h ar d, rig id  to  to u ch. 
 
4.  
U n der mi ni n g : Sc ore as = 0 if w ou n d h eale d/res ol ve d. Assess b y i ns ertin g a c o tto n tip p e d ap p licat or u n der t he  wo u n d e d ge; 
a d va nce it as far as it w ill g o with o ut us i n g u n d ue f or ce; raise t he tip of t he a p p licat or s o it ma y be seen or felt o n t he s urface of 
t he s ki n; mark t he s urface with a pe n; m eas ure t he dista nce fr om t he m ark o n t he  s ki n t o t he e d ge of t he wou n d. C o n tin u e 
pr o cess ar ou n d t he wo u n d. T he n us e a tra ns pare nt m etric meas urin g  g u i de with c o n centric circles di vi de d i nt o 4 ( 2 5%) pie-
s ha pe d q ua dra nts t o hel p de ter mi ne perce nt of wo u n d  in v ol ve d. 
 
5.  
Necr otic Ti ssue T y pe : Pick t he t y pe of n ecr otic tiss ue t hat is pr ed o mi na nt i n t he wo u n d accor d i n g t o c olor , c ons istenc y a n d 
a d here nce us i n g t his g u i de: 
W h ite/g ray  n o n -v iab le tiss ue 
=  
m ay  ap p ear pr io r to  w o u n d  o p en in g ; s kin  s urface is 
 
 
w h ite o r g ray . 
N o n -ad h eren t, y ello w  slo u g h  
=  
th in , m u cin o u s s ub stan ce; scattered  th r ou g h o u t w o u n d  
 
 
be d ; easily  se para ted  fr om  w o u n d  tiss ue. 
L o o sely  ad h eren t, y ello w  slo u g h  
=  
th ick , strin g y , clu m p s o f d ebr is; attach ed  to  w o u n d  
 
 
tiss ue. 
A d h ere n t, so ft, b lack  esch ar 
=  
so g g y  tiss ue; str on g ly  attach ed  to  tiss ue in  cen ter o r 
 
 
ba se o f w o u n d . 
Fi rm ly  a dh ere n t, h ar d /b lack  esch ar 
=  
firm , crus ty  tiss ue; str on g ly  attach ed  to  w o u n d  b ase an d  
 
 
e dg es (lik e a h ard  sca b) . 
© 2 0 0 1 Ba rba ra Bat es-Jen se n Use d wit h per missi o n   
 

M e dli n e I n d u stri e s, I n c. 
 
 
Fi brill ar dr e s si n g f or tr e ati n g c hr o ni c, st all e d w o u n d s  
M E D- 2 0 1 8- DI V 7 1- 0 0 8 
 
C O N FI D E N TI A L                        
2 3 A u g u st 2 0 1 8 
V 1 . 0 
 
 
3 2  
 
6.  
Necr otic Ti ssue A mo u n t: Use a trans pare nt metric m eas uri n g g u i de with c on centric ci rcles di vi de d i nt o 4 ( 2 5%) pie-
s ha pe d q ua dr a nts t o h elp deter mi ne per cent of wo u n d i n v ol ve d.  
 
7.  
E x u d at e T y pe : S o me dre ssin g s i nteract with wo u n d drai na ge t o pr o d uce a gel or t rap liq ui d. Bef or e assessi n g ex u da te t ype , 
ge n tly cl eans e wo u n d w ith n or mal sa line or wat er. Pic k t he ex u da te t ype t hat is pr ed o mi na nt i n  t he wou n d acc or d i n g t o c ol or 
a n d c o ns istenc y, us i n g t his g u i de: 
 
B lo o d y  
=  
th in , br ig h t red  
Se r osan g u in eo us  
=  
th in , w atery  p ale red  to  p in k  
Se r ous  
=  
th in , w atery , clear 
P u ru lent 
=  
th in  o r th ick , o pa q u e tan  to  y ello w  o r g reen  m ay  h av e o ffens iv e 
 
 
o d or  
 
8.  
E x u d at e A mo u n t: Use a trans pare nt m etric meas uri n g g u i de with c o n centric circles di vi de d i nt o 4 ( 2 5 %) pie- s ha pe d 
q ua dr a nts t o deter mi ne per cent of dr essi n g in v ol ve d w ith e x u date. Use t his g u i de: 
 
N o ne  
=  
w o u n d  tiss ues dr y . 
S can t 
=  
w o u n d  tiss ues m o ist; n o  m eas ura ble ex u da te. 
S m all 
=  
w o u n d  tiss ues w et; m o istu re ev en ly  d istrib u ted  in  w o u n d ; dr ain ag e 
 
 
in v o lv es <  2 5 %  dr essin g . 
M o dera te 
=  
w o u n d  tiss ues satu rate d; dra in ag e m ay  o r m ay  n o t b e ev en ly  d istrib u ted  i n 
 
 
w o u n d ; dr ain ag e in v o lv es >  2 5 %  to  <  7 5 %  dr essin g . 
L arg e 
=  
w o u n d  tiss ues ba th ed  in  flu id ; dra in ag e freely  ex pre sse d; m ay  o r m ay  n o t 
 
 
b e ev en ly  d istrib u ted  in  w o u n d ; dr ain ag e in v o lv es >  7 5 %  o f dr essin g.  
 
9.  
S ki n C ol or S urr o u n di n g W o u n d : Assess tiss ues withi n 4c m of wo u n d e d ge. Da r k-s kin n e d pers o ns s ho w t he  c olor s "br ig h t 
re d" a n d " dar k re d" as a dee pe ni n g of n or mal et h n ic s ki n c ol or or a p ur ple h u e. As h ealin g  occ urs i n dar k- s kin n e d pers o ns , t he 
ne w s ki n is pi n k a n d ma y ne ver dar ke n.  
 
1 0.  
Peri p her al Ti ssue E de ma & I n d ur at i o n: Assess tiss ues withi n 4c m of wo u n d e d ge. N o n- pitti n g e de ma a p p ears as s ki n 
t hat is s hi n y a n d taut. I de ntif y pitti n g e de ma b y fir ml y pr essi n g a fin g er d o wn i nt o t he tiss ues a n d waiti n g f or 5 s ec o n ds, o n 
release of pr ess ure, tiss ues fail t o res ume pr e vi o us p o sitio n a n d a n i n de ntati o n a p p ears. I n d urati o n is a b nor mal fir mness of 
tiss ues with mar gi ns . Assess b y ge n tly pi nc hi n g t he tiss ues. I n d urati o n re s ults i n a n i na bilit y t o pi nc h t he tiss ues. Use a 
trans pare nt metric m eas uri n g g u i de t o de ter mi ne h o w far e de ma or i n d urati o n e x ten ds be yo n d wo u n d.  
 
1 1.  
Gr a n ul at i o n Tissue : Gran u lati o n tiss ue is t he g r owt h of s m all blo o d ve ssels a n d c on n ecti ve tiss ue t o fill i n f ull t hick n ess 
wo u n ds. Tiss ue is healt h y whe n br ig h t, beef y re d, s hi n y a n d gran u lar with a vel vet y a p peara n ce. Po o r vasc ular s up p l y ap p ears 
as p ale pi n k or b lanc he d t o d u ll, d us k y re d c olor . 
 
1 2.  
E pi t heli alizat i o n: E p ithe lializatio n is t he pr ocess of e pi der mal res urfaci n g a n d a p pears as pi n k or red s ki n. I n par tial t hick n ess 
wo u n ds it can o ccur t h r ou g h o ut t he w o u n d be d as w ell as fr om t he wo u n d e d ges. I n f ull t hick n ess wo u n ds it occ urs f r om t he 
e dges o nl y. Use a t rans pare nt metric m eas uri n g g u i de with c on centric  circles di vi de d i nt o 4 ( 2 5%) p ie-s ha pe d q ua dra nts t o 
hel p de ter mi ne perce nt of w o u n d i n v ol ve d a n d t o m eas ure t he distance t he e p ithelial tiss ue e xten ds i nt o t he wo u n d. 
 
© 2 0 0 1 Ba rba ra Bates-Je nse n Use d wit h per missi o n 
 
 
 
 
 

M e dli n e I n d u stri e s, I n c. 
 
 
Fi brill ar dr e s si n g f or tr e ati n g c hr o ni c, st all e d w o u n d s  
M E D- 2 0 1 8- DI V 7 1- 0 0 8 
 
C O N FI D E N TI A L                        
2 3 A u g u st 2 0 1 8 
V 1 . 0 
 
 
3 3  
 
1 1. 3. 3. 2.  B W A T Case Re p ort F or m 
 
S u bject N u m ber: _ _ _ _ _ _ _ _ _ _ _               Date: _ _ _ _ _ _ _ _ _ _ _          Assess me nt N u m ber: _ _ _ _ _ _ _ _ _ _ 
 
C o mplete t he ratin g s heet t o assess wo u n d stat us . E val uate eac h ite m b y pic ki n g t he resp o ns e t hat be st de scribe s t he wo u n d a n d 
e nteri n g t he sc ore i n t he ite m sc ore c ol u mn f or t he a p pr o priate da te. If t he wou n d has h eale d/res ol ve d, sc ore ite ms 1, 2, 3, & 4 as = 0 . 
L oc at i o n: A nato mic site. Circle, i de n tif y rig h t ( R) or left ( L) a n d us e " X " t o mar k site o n b o d y d iagra ms: 
 
         
S acr u m  &  c occ y x  
         
L atera l an k le 
         
T r och an ter 
         
Me d ial an k le 
         
Isch ial tu b er osit y 
         
Hee l 
         
B u tto ck  
         
Ot h er site:                                         . 
S h a pe : O verall wo u n d pa ttern; a ssess b y o b servi n g peri meter a n d de pt h.   
 
Ci rcle a n d date ap pr o pr iate descri ptio n: 
         
Irreg u lar 
         
L in ear o r elo n g ate d 
         
R o u n d /o v al 
         
B o w l/b oat  
         
S q u are /rectan g le          
B u tterfly              Ot h er S h a pe 
 
 
Item  
 
Assess me nt  
D at e 
S c ore 
1 . Size *  
* 0  =  Hea led , reso lv ed  w o u n d  
1  =  L en g th  x  w id th  < 4  sq  c m  
2  =  L en g th  x  w id th  4 --< 1 6  sq  c m 
3  =  L en g th  x  w id th  1 6 .1 --< 3 6  sq  c m   
4  =  L en g th  x  w id th  3 6 .1 --< 8 0  sq  c m   
5  =  L en g th  x  w id th  > 8 0  sq  c m  
 
2 . De p th *  
* 0  =  Hea led , reso lv ed  w o u n d  
1  =  N o n -b lan ch ab le ery th em a o n  in tact sk in  
2  =  P ar tial th ick n ess sk in  lo ss in v o lv in g  ep id er m is & /o r d er m is 
3  =  F u ll th ick n ess sk in  lo ss in v o lv in g  d am ag e o r n ecr o sis o f su b cu tan eo u s 
tissu e; m a y  ex ten d  d o w n  to  b u t n o t th ro u g h  u n d er ly in g  fascia; & /o r 
m ix e d  p ar tial &  f ull th ick n ess & /o r tissu e lay ers  o b scu re d b y  g ran u latio n  
tissu e   
4  =  O b scu re d b y  n ecr o sis 
5  =  F u ll th ick n ess sk in  lo ss w ith  ex ten siv e d estru ctio n , tissu e n ecr o sis o r 
d am ag e to  m u scle, b o n e o r su p p o rtin g  stru ctu res 
 
3 . E d g es*  
* 0  =  Hea led , reso lv ed  w o u n d  
1  =  In d istin ct, d iff use, n o n e clear ly  v isib le 
2  =  D istin ct, o u tlin e clear ly  v isib le, attac h ed , ev e n w ith  w o u n d  b ase 3  =  
W ell-d efin ed , n o t attac h e d  to  w o u n d  b ase 
4  =  W ell-d efin ed , n o t attac h e d to  b ase, ro lle d u n d er,  th ick en e d   
5  =  W ell-d efin ed , fib ro tic, scarre d  o r h y p er k era to tic 
 
4 . U n der - m i ni ng *  
* 0  =  Hea led , reso lv ed  w o u n d  
1  =  N o n e p resen t 
2  = U n d er m in in g  <  2  c m  in  an y  area  
3  =  U n d erm in in g  2 -4  cm  in v o lv in g  <  5 0 %  w o u n d  m arg ins   
4  =  U n d erm in in g  2 -4  cm  in v o lv in g  >  5 0 %  w o u n d  m arg ins   
5  =  U n d erm in in g  >  4  cm  o r T u n n elin g  in  an y  area 
 
5 . N ecr ot ic T issu e  
T y p e 
1  =  N o n e v isib le 
2  =  W h ite/g re y n o n -v iab le tissu e & /o r n o n -ad h ere n t y ello w  slo u g h  
3  =  L o o sely  ad h ere n t y ello w  slo u g h  
4  =  A d h ere n t, so ft, b lac k  esch ar 
5  =  Fi rm ly  ad h ere n t, h ar d , b lac k  esch ar  
 
 

M e dli n e I n d u stri e s, I n c. 
 
 
Fi brill ar dr e s si n g f or tr e ati n g c hr o ni c, st all e d w o u n d s  
M E D- 2 0 1 8- DI V 7 1- 0 0 8 
 
C O N FI D E N TI A L                        
2 3 A u g u st 2 0 1 8 
V 1 . 0 
 
 
3 4  
 
6 . N ecr ot ic T issu e  
A m o u nt  
1  =  N o n e v isib le 
2  =  <  2 5 %  o f w o u n d  b e d  co v ere d   
3  =  2 5 %  to  5 0 %  o f w o u n d  co v ere d  
4  =  >  5 0 %  an d  <  7 5 %  o f w o u n d  co v ere d   
5  =  7 5 %  to  1 0 0 %  o f w o u n d  co v ere d  
 
7 . E x u d at e T y pe  
1  =  N o n e 
2 = Bl o o d y  
3 = Ser osa n g ui ne o us: t hi n, water, pale re d/ pi n k 
4 = Ser o us: t hi n k, water y, clear  
5 = P ur ule nt: t hi n or t hic k, o pa q ue, ta n/ yell o w, wit h or wit h o ut o d or  
 
8. E x u d ate A m o u nt  
1 = N o ne, dr y w o u n d  
2 = Sca nt, w o u n d m oist b ut n o o bser va ble e x u date  
3 = S mall  
4 = M o derate  
5 = Lar ge  
 
9. S ki n C ol or 
S urr o u n di n g 
W o u n d  
1 = Pi n k or n or mal f or et h nic gr o u p  
2 = Bri g ht re d &/ or bla nc hes t o t o uc h  
3 = W hite or gre y pall or or h y p o pi g me nte d  
4 = Dar k re d or p ur ple &/ or n o n -bla nc ha ble  
5 = Blac k or h y per pi g me nte d  
 
1 0. Peri p her al Tiss ue 
E de m a  
1 = N o s welli n g or e de ma  
2 = N o n -pitti n g e de ma e xte n ds < 4c m ar o u n d w o u n d  
3 = N o n -pitti n g e de ma e xte n ds ≥ 4c m ar o u n d w o u n d  
4 = Pitti n g e de ma e xte n ds < 4c m ar o u n d w o u n d  
5 = Pitti n g e de ma e xte n ds ≥ 4c m ar o u n d w o u n d  
 
1 1. Peri p her al Tiss ue 
I n d ur ati o n  
1 = N o ne prese nt  
2 = I n d urati o n < 2c m ar o u n d w o u n d  
3 = I n d urati o n 2 -4c m e xte n di n g < 5 0 % ar o u n d w o u n d  
4 = I n d urati o n 2 -4c m e xte n di n g ≥5 0 % ar o u n d w o u n d  
5 = I n d urati o n > 4c m i n a n y area ar o u n d w o u n d  
 
1 2. Gr a n ul ati o n 
Tiss ue  
1 = S ki n i ntact or partial t hic k ness w o u n d  
2 = Bri g ht, beef y re d; 7 5 % t o 1 0 0 % of w o u n d fille d &/ or tiss ue o ver gr o wt h  
3 = Bri g ht, beef y re d; < 7 5 % & > 2 5 % of w o u n d fille d  
4 = Pi n k, &/ or d ull, d us k y re d &/ or fills ≤2 5 % of w o u n d  
5 = N o gra n ulati o n tiss ue prese nt  
 
1 3. E pit heli aliz ati o n  
1 = 1 0 0 % w o u n d c o vere d, s urf ace i ntact  
2 = 7 5 % t o < 1 0 0 % w o u n d c o vere d &/ or e pit helial tiss ue e xte n ds > 0. 5c m 
i nt o w o u n d be d 
3 = 5 0 % t o < 7 5 % w o u n d c o vere d &/ or e pit helial tiss ue e xte n ds < 0. 5c m 
i nt o w o u n d be d 
4 = 2 5 % t o < 5 0 % w o u n d c o vere d  
5 = < 2 5 % w o u n d c o vere d  
 
  T ot al Sc ore  
 
  Si g n at ure  
 
 
Pl ot t he t o tal scor e o n t he W o u n d Stat us C o n tin u u m b y p u ttin g a n " X " o n t he line a n d t he d ate be neat h t he line .   
© 2 0 0 1 Bar ba ra Bates-Je nse n     Use d wit h per missi o n

M e dli n e I n d u stri e s, I n c. 
 
 
Fi brill ar dr e s si n g f or tr e ati n g c hr o ni c, st all e d w o u n d s  
M E D- 2 0 1 8- DI V 7 1- 0 0 8 
 
C O N FI D E N TI A L                        
2 3 A u g u st 2 0 1 8 
V 1 . 0 
 
 
3 5  
 
1 1. 3. 4.  Dressi n g L o g  Case Re p ort F or m 
Dressi n g L o g C ase Re p ort F or m  
M E D -2 0 1 8 -DI V 7 1 -0 0 8:  A case series e val uati n g a fi brillar c olla ge n p o w der dressi n g t o treat c hr o nic, stalle d l o wer
-e xtre mit y 
w o u n ds  
S u bject N u m ber:    
C h a n g e # 1 D at e:  
S e c o n d ar y Dr e s si n g ( s) A p pli e d:  
C h a n g e # 2 D at e:  
S e c o n d ar y Dr e s si n g ( s) A p pli e d:  
C h a n g e # 3 D at e:  
S e c o n d ar y Dr e s si n g ( s) A p pli e d:  
C h a n g e # 4 D at e:  
S e c o n d ar y Dr e s si n g ( s) A p pli e d:  
C h a n g e # 5 D at e:  
S e c o n d ar y Dr e s si n g ( s) A p pli e d:  
C h a n g e # 6 D at e:  
S e c o n d ar y Dr e s si n g ( s) A p pli e d:  
C h a n g e # 7 D at e:  
S e c o n d ar y Dr e s si n g ( s) A p pli e d:  
C h a n g e # 8  D at e:  
S e c o n d ar y Dr e s si n g ( s) A p pli e d:  
C h a n g e # 9  D at e:  
S e c o n d ar y Dr e s si n g ( s) A p pli e d:  
C h a n g e # 1 0  D at e:  
S e c o n d ar y Dr e s si n g ( s) A p pli e d:  
C h a n g e # 1 1  D at e:  
S e c o n d ar y Dr e s si n g ( s) A p pli e d:  
C h a n g e # 1 2  D at e:  
S e c o n d ar y Dr e s si n g ( s) A p pli e d:  
C h a n g e # 1 3  D at e:  
S e c o n d ar y Dr e s si n g ( s) A p pli e d:  
C h a n g e # 1 4  D at e:  
S e c o n d ar y Dr e s si n g ( s) A p pli e d:  
C h a n g e # 1 5  D at e:  
S e c o n d ar y Dr e s si n g ( s) A p pli e d:  

M e dli n e I n d u stri e s, I n c. 
 
 
Fi brill ar dr e s si n g f or tr e ati n g c hr o ni c, st all e d w o u n d s  
M E D- 2 0 1 8- DI V 7 1- 0 0 8 
 
C O N FI D E N TI A L                        
2 3 A u g u st 2 0 1 8 
V 1 . 0 
 
 
3 6  
 
Dressi n g L o g C ase Re p ort F or m  
M E D -2 0 1 8 -DI V 7 1 -0 0 8:  A case series e val uati n g a fi brillar c olla ge n p o w der dressi n g t o treat c hr o nic, stalle d l o wer
-e xtre mit y 
w o u n ds  
C h a n g e # 1 5 D at e:  
S e c o n d ar y Dr e s si n g ( s) A p pli e d:  
C h a n g e # 1 6 D at e:  
S e c o n d ar y Dr e s si n g ( s) A p pli e d:  
C h a n g e # 1 7 D at e:  
S e c o n d ar y Dr e s si n g ( s) A p pli e d:  
C h a n g e # 1 8 D at e:  
S e c o n d ar y Dr e s si n g ( s) A p pli e d:  
C h a n g e # 1 9 D at e:  
S e c o n d ar y Dr e s si n g ( s) A p pli e d:  
C h a n g e # 2 0 D at e:  
S e c o n d ar y Dr e s si n g ( s) A p pli e d:  
C h a n g e # 2 1 D at e:  
S e c o n d ar y Dr e s si n g ( s) A p pli e d:  
C h a n g e # 2 2  D at e:  
S e c o n d ar y Dr e s si n g ( s) A p pli e d:  
C h a n g e # 2 3  D at e:  
S e c o n d ar y Dr e s si n g ( s) A p pli e d:  
C h a n g e # 2 4  D at e:  
S e c o n d ar y Dr e s si n g ( s) A p pli e d:  
C h a n g e # 2 5  D at e:  
S e c o n d ar y Dr e s si n g ( s) A p pli e d:  
C h a n g e # 2 6  D at e:  
S e c o n d ar y Dr e s si n g ( s) A p pli e d:  
C h a n g e # 2 7  D at e:  
S e c o n d ar y Dr e s si n g ( s) A p pli e d:  
C h a n g e # 2 8  D at e:  
S e c o n d ar y Dr e s si n g ( s) A p pli e d:  
C h a n g e # 2 9  D at e:  
S e c o n d ar y Dr e s si n g ( s) A p pli e d:  
C h a n g e # 3 0  D at e:  
S e c o n d ar y Dr e s si n g ( s) A p pli e d:  
C h a n g e # 3 1  D at e:  
S e c o n d ar y Dr e s si n g ( s) A p pli e d:  

M e dli n e I n d u stri e s, I n c. 
 
 
Fi brill ar dr e s si n g f or tr e ati n g c hr o ni c, st all e d w o u n d s  
M E D- 2 0 1 8- DI V 7 1- 0 0 8 
 
C O N FI D E N TI A L                        
2 3 A u g u st 2 0 1 8 
V 1 . 0 
 
 
3 7  
 
Dressi n g L o g C ase Re p ort F or m  
M E D -2 0 1 8 -DI V 7 1 -0 0 8:  A case series e val uati n g a fi brillar c olla ge n p o w der dressi n g t o treat c hr o nic, stalle d l o wer
-e xtre mit y 
w o u n ds  
C h a n g e # 3 2  D at e:  
S e c o n d ar y Dr e s si n g ( s) A p pli e d:  
C h a n g e # 3 3  D at e:  
S e c o n d ar y Dr e s si n g ( s) A p pli e d:  
C h a n g e # 3 3  D at e:  
S e c o n d ar y Dr e s si n g ( s) A p pli e d:  
C h a n g e # 3 4  D at e:  
S e c o n d ar y Dr e s si n g ( s) A p pli e d:  
C h a n g e # 3 5  D at e:  
S e c o n d ar y Dr e s si n g ( s) A p pli e d:  
C h a n g e # 3 6  D at e:  
S e c o n d ar y Dr e s si n g ( s) A p pli e d:  
C h a n g e # 3 7  D at e:  
S e c o n d ar y Dr e s si n g ( s) A p pli e d:  
C h a n g e # 3 8  D at e:  
S e c o n d ar y Dr e s si n g ( s) A p pli e d:  
C h a n g e # 3 9  D at e:  
S e c o n d ar y Dr e s si n g ( s) A p pli e d:  
C h a n g e # 4 0  D at e:  
S e c o n d ar y Dr e s si n g ( s) A p pli e d:  
C h a n g e # 4 1  D at e:  
S e c o n d ar y Dr e s si n g ( s) A p pli e d:  
C h a n g e # 4 2  D at e:  
S e c o n d ar y Dr e s si n g ( s) A p pli e d:  
C h a n g e # 4 3  D at e:  
S e c o n d ar y Dr e s si n g ( s) A p pli e d:  
C h a n g e # 4 4  D at e:  
S e c o n d ar y Dr e s si n g ( s) A p pli e d:  
C h a n g e # 4 5  D at e:  
S e c o n d ar y Dr e s si n g ( s) A p pli e d:  
C h a n g e # 4 6  D at e:  
S e c o n d ar y Dr e s si n g ( s) A p pli e d:  
C h a n g e # 4 7  D at e:  
S e c o n d ar y Dr e s si n g ( s) A p pli e d:  

M e dli n e I n d u stri e s, I n c. 
 
 
Fi brill ar dr e s si n g f or tr e ati n g c hr o ni c, st all e d w o u n d s  
M E D- 2 0 1 8- DI V 7 1- 0 0 8 
 
C O N FI D E N TI A L                        
2 3 A u g u st 2 0 1 8 
V 1 . 0 
 
 
3 8  
 
Dressi n g L o g C ase Re p ort F or m  
M E D -2 0 1 8 -DI V 7 1 -0 0 8:  A case series e val uati n g a fi brillar c olla ge n p o w der dressi n g t o treat c hr o nic, stalle d l o wer
-e xtre mit y 
w o u n ds  
C h a n g e # 4 8  D at e:  
S e c o n d ar y Dr e s si n g ( s) A p pli e d:  
C h a n g e # 4 9  D at e:  
S e c o n d ar y Dr e s si n g ( s) A p pli e d:  
C h a n g e # 5 0  D at e:  
S e c o n d ar y Dr e s si n g ( s) A p pli e d:  
C h a n g e # 5 1  D at e:  
S e c o n d ar y Dr e s si n g( s) A p pli e d:  
C h a n g e # 5 2  D at e:  
S e c o n d ar y Dr e s si n g( s) A p pli e d:  
C h a n g e # 5 3  D at e:  
S e c o n d ar y Dr e s si n g( s) A p pli e d:  
C h a n g e # 5 4  D at e:  
S e c o n d ar y Dr e s si n g( s) A p pli e d:  
C h a n g e # 5 5  D at e:  
S e c o n d ar y Dr e s si n g( s) A p pli e d:  
C h a n g e # 5 6  D at e:  
S e c o n d ar y Dr e s si n g( s) A p pli e d:  
C h a n g e # 5 7  D at e:  
S e c o n d ar y Dr e s si n g( s) A p pli e d:  
C h a n g e # 5 8  D at e:  
S e c o n d ar y Dr e s si n g( s) A p pli e d:  
C h a n g e # 5 9  D at e:  
S e c o n d ar y Dr e s si n g( s) A p pli e d:  
C h a n g e # 6 0 D at e:  
S e c o n d ar y Dr e s si n g( s) A p pli e d:  
C h a n g e # 6 1  D at e:  
S e c o n d ar y Dr e s si n g( s) A p pli e d:  
C h a n g e # 6 2  D at e:  
S e c o n d ar y Dr e s si n g( s) A p pli e d:  
C h a n g e # 6 3  D at e:  
S e c o n d ar y Dr e s si n g( s) A p pli e d:  

M e dli n e I n d u stri e s, I n c. 
 
 
Fi brill ar dr e s si n g f or tr e ati n g c hr o ni c, st all e d w o u n d s  
M E D- 2 0 1 8- DI V 7 1- 0 0 8 
 
C O N FI D E N TI A L                        
2 3 A u g u st 2 0 1 8 
V 1 . 0 
 
 
3 9  
 
1 1. 4.  
A d verse E ve nt F or m 
Sit e/ S u bj e ct I nf or m ati o n  
St u d y S p o n s or: M e dli n e I n d u stri e s, I n c.  
Pr ot o c ol N u m b er:  M E D -2 0 1 8 -DI V 7 1 -0 0 8  
Sit e N u m b er:  
Pri n ci p al I n v e sti g at or: 
S u bj e ct N u m b er:  
 
 
A d v er s e E v e nt I nf or m ati o n  
#  
A d v er s e E v e nt:  
St art 
D at e:  
D D -M M M -
Y Y Y Y  
St o p 
D at e:  
D D -M M M -
Y Y Y Y  
O n g oi n g:  Fr e q u e n c y:  S e v erit y:  O ut c o m e:  I P L ot #: R el ati o n -
s hi p t o I P:  
A cti o n 
T a k e n  
wit h I P:  
S A E 
St at u s:  
C o m m e nt:  
 
 
 E x p e ct e d  
 
 
 Y e s  
 
 
 
 
 
 
 Y e s*  
 
 U n e x p e ct e d  
 N o  
 N o  
 
 
 E x p e ct e d  
 
 
 Y e s  
 
 
 
 
 
 
 Y e s*  
 
 U n e x p e ct e d  
 N o  
 N o  
 
 
 E x p e ct e d  
 
 
 Y e s  
 
 
 
 
 
 
 Y e s*  
 
 U n e x p e ct e d  
 N o  
 N o  
Fr e q u e n c y:  
S e v erit y:  
O ut c o m e:  
R el ati o n s hi p t o I P:  
A cti o n T a k e n wit h I P:  
S A E St at u s  
1 = I s ol at e d  
2 = I nt er mitt e nt  
3 = C o nti n u o u s  
1 = Mil d  
2 = M o d er at e  
3 = S e v er e  
1 = R e s ol v e d, wit h n o s e q u el a e  
2 = R e s ol v e d, wit h s e q u el a e  
3 = U nr e s ol v e d  
4 = D e at h  
5 = U n k n o w n  
1 = N ot R el at e d  
2 = P o s si bl e  
3 = Pr o b a bl e  
4 = D efi nit e  
1 = N o n e  
2 = M o difi e d  
3 = I nt err u pt e d  
4 = Di s c o nti n u e d  
D e at h, lif e -t hr e at e ni n g, 
pr ol o n g e d h o s pit ali z ati o n, 
si g nifi c a nt di s a bili t y/ a n o m al y, 
m e di c al i nt er v e nti o n t o pr e v e nt 
a s eri o u s o ut c o m e  
*I n t h e e v e nt of a S eri o u s A d v er s e E v e nt, pl e a s e c o m pl et e t h e S eri o u s A d v er s e E v e nt R e p ort f or m a n d 
 
s e n d t o M e dli n e I n d u stri e s, I n c. wit hi n 4 8 h o ur s of a w ar e n e s s
 

M e dli n e I n d u stri e s, I n c. 
 
 
Fi brill ar dr e s si n g f or tr e ati n g c hr o ni c, st all e d w o u n d s  
M E D- 2 0 1 8- DI V 7 1- 0 0 8 
 
C O N FI D E N TI A L                        
2 3 A u g u st 2 0 1 8 
V 1 . 0 
 
 
4 0  
 
1 1. 5.  
Seri o us A d verse E ve nt 
Sit e I nf or m ati o n  
St u d y S p o n s or: M e dli n e I n d u stri e s I n c.  
Pr ot o c ol N u m b er:  M E D -2 0 1 8 -DI V 7 1 -0 0 8  
Sit e N u m b er:  
Pri n ci p al I n v e sti g at or:  
Sit e A d dr e s s:  
R e p ort T y p e:  
 I niti al 
 F oll o w -u p  
 Fi n al  
F or m C o m pl et e d B y:  
Titl e:  
T el e p h o n e:  
E -m ail:  
 
S eri o u s A d v er s e E v e nt I nf or m ati o n  
S u bj e ct N u m b er:  
 
S u bj e ct I niti al s:  
Birt h D at e:  
G e n d er:  
 M al e  
 F e m al e  
I n v e sti g ati o n al Pr o d u ct: 
E v e nt D e s cri pti o n: ( Pl e a s e i n cl u d e a d et ail e d d e s cri pti o n of t h e e v e nt i n q u e sti o n, i n cl u di n g t h e r e s ult s of a n y 
l a b or at or y/ di a g n o sti c i m a g er y t e sti n g)  
Sit e N otifi c ati o n  
of t h e E v e nt:  
D at e N otifi e d:  
Ti m e N otifi e d:  
M et h o d of N otifi c ati o n:  
E v e nt St art/ St o p:  
St art D at e:  
St o p D at e:  
 O n g oi n g  
E v e nt Q u alifi er s:  
( C h e c k all t h at a p pl y)  
 D e at h  
 I nt er v e nti o n t o Pr e v e nt I m p air m e nt  
 Lif e -T hr e at e ni n g  
 Di s a bilit y/ P er m a n e nt D a m a g e  
 I niti al or Pr ol o n g e d H o s pit ali z ati o n  
 C o n g e nit al A n o m al y  
 Ot h er:  

M e dli n e I n d u stri e s, I n c. 
 
 
Fi brill ar dr e s si n g f or tr e ati n g c hr o ni c, st all e d w o u n d s  
M E D- 2 0 1 8- DI V 7 1- 0 0 8 
 
C O N FI D E N TI A L                        
2 3 A u g u st 2 0 1 8 
V 1 . 0 
 
 
4 1  
 
R el e v a nt M e di c al Hi st or y:  
C o n c o mit a nt M e di c ati o n/ D e vi c e Hi st or y: ( Pl e a s e i n cl u d e hi st ori c al i nf or m ati o n s u c h a s m e di c ati o n/ d e vi c e n a m e, 
d o s a g e, fr e q u e n c y, r o ut e, st art d at e, et c.)  
R el ati o n s hi p t o 
I n v e sti g ati o n al Pr o d u ct 
(I P): 
 N ot R el at e d ( e v e nt d efi nit el y n ot r el at e d t o I P, a s j u d g e d b y t h e Pri n ci p al I n v e sti g at or)
 
 P o s si bl y R el at e d ( e v e nt m a y b e r el at e d t o I P, a s j u d g e d b y t h e Pri n ci p al I n v e sti g at or)
 
 R el at e d ( e v e nt d efi nit el y r el at e d t o I P, a s j u d g e d b y t h e Pri n ci p al I n v e sti g at or)
 
A cti o n T a k e n wit h 
I n v e sti g ati o n al Pr o d u ct: 
 Di s c o nti n u e d - Pl e a s e Pr o vi d e D at e:  
 I nt err u pt e d- Pl e a s e Pr o vi d e D at e:  
 N o n e  
C o m m e nt s:  
 
C o nfir m ati o n of R e c ei pt:  
S E C TI O N T O B E C O M P L E T E D B Y M E D LI N E I N D U S T RI E S I N C.  
D at e R e c ei v e d:  
Ti m e R e c ei v e d:  
R e c ei v e d B y:  
Titl e: