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Table 2 Interventions and outcomes of the studies

From: Systematic review on the rational use of amniotic membrane allografts in diabetic foot ulcer treatment

 

Author

Year

Study type

Intervention and size of the group

Evaluation frequency

Follow-up time

Healing time(days) /(SD)

Healed percentage

Recurrences

Adverse outcomes. (amniotic membrane product related)

1

Thompson et al. [1]

2019

RCT

Human amniotic allograft 7

SOC-6

Weekly

12 weeks

I-29.50(15.41)

C- 26.20(8.93)

(p value has not been calculated due to small sample size)

NA

90-day recurrence rate

I-14.29%

C-83.3%

NA

2

Tettebach et al. [5]

2019

RCT

dHACM – 54

SOC- 56

Weekly

12 weeks

P = 0.0187 (Kaplan–Meier plot of time to heal)

I-70%

C-50%

P = 0.0338

112-day recurrence

I-5%

C-14%

3 product related events

3

Didomenico et al. [9]

2016

RCT

AmnioBand 20

SOC 20

Weekly

12 weeks

I – 36.0

C – 70.0

P = 0.00073

I-85%, C-25%

P = 0.00073

Odds ratio = 17

NA

NA

4

Snyder et al. [10]

2016

RCT

AMNIOEXCEL 15

SOC 14

Weekly

6 weeks

NA

I-35%,

C-0%

P = 0.017

NA

Not observed

5

Zelen et al.[11]

2015

RCT

EpiFIx 32

Apligraf 33

SOC 35

Weekly

12 weeks

I1-23.6

I2- 47.9

C = 57.4

I1-97%

I2-73%

C-51

P = 0.0019

NA

Not observed

6

Zelen et al. [12]

2014

RCT

Epifix 20

SOC 20

I – weekly

C—biweekly

12 weeks

I-16.8(12.6)

C-29.0(17)

P = 0.039

I-85%

C-100%

NA

Not observed

7

Lavery et al. [13]

2014

RCT

Grafix 50

SCO 47

Weekly

12 weeks

I-42.0

C-69.5

P = 0.019

I-62.0%

C-21.3%

P = 0.0001

NA

Would infections were low in interventional group (p = 0.044)

8

Zelen et al. [2]

2013

RCT

Epifix 13

SOC 12

Weekly

6 weeks

I-17.5(13.3)

C-35.0

I-92%

C-8%

P = 0.0001

NA

NA

9

Valiente et al. [14]

2018

Prospective

Case series

Cryopreserved amniotic membrane 14

Weekly

Until complete closure

Median time 20 weeks (range 7–56)

NA

NA

Not observed

10

Abdo [15]

2016

Prospective

Cases series

AMNIOEXCEL 14

Weekly

Until complete closure

Median 5 weeks (range 1014 weeks)

NA

NA

NA

11

Raphael [16]

2016

Retrospective study

NEOX CORD 1 K

(cryopreserved amniotic membrane) 29

Weekly

Until complete closure

Mean 96.6(13.65) days

Median 9 weeks

87.5%

NA

NA

12

Kirsner et al. [17]

2015

Retrospective study

dHACM 63

NA

24 weeks

Median time 26 weeks

At 12 weeks-28%

At 24 weeks-47%

NA

NA

  1. SD standard deviation, RCT randomized control trials, SOC standard of care, I intervention group, C control group, dHACM dehydrated human amnion/chorionic membrane