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Table 2 Baseline information about the statuses of diabetes mellitus and diabetic foot ulceration (DFU)

From: Effectiveness and safety of dermal matrix used for diabetic foot ulcer: a systematic review and meta-analysis of randomized controlled trials

Study ID

Interventions

No. of patients

HbA1c%

ABI

DPN%

DFU grade

Site of DFU

DFU size (cm2)

DFU age

Brigido, 2004 [22]

SOC

20

NA

NA

NA

NA

NA

NA

Mean: 25w

GraftJacket tissue matrix

20

Mean: 27w

Driver, 2015 [23]

SOC

153

8.2 ± 1.9

NA

NA

Wagner 2:116 (75.8%)

Dorsal: 127(83.6%);

Plantar: 25(16.5%)

3.7 ± 2.7

303 ± 418d

SOC + IDRT

154

8.0 ± 1.8

Wagner 2: 109 (70.8%)

Dorsal: 126(81.8%);

Plantar: 28(18.2%)

3.5 ± 2.5

308 ± 491d

Cazzell, 2019 [24]

SOC + ADM allograft

61

NA

NA

42.6%

Wagner 3: 59 (96.7%);

Wagner 4: 2 (3.3%)

Ankle: 1(1.6%);

Dorsal: 33(54.1%);

Plantar: 26(42.6%);

Plantar/dorsal: 1(1.6%)

29.0 ± 21.0

3.8 ± 3.4 m

Zelen, 2016 [25]

SOC

20

7.8 ± 1.8

NA

NA

NA

Toe: 7(35.0%);

Forefoot: 7(35.0%);

Midfoot: 2(10.0%);

Ankle/hindfoot: 4(20.0%)

2.7 ± 2.3

NA

SOC + human reticular CDM

20

7.9 ± 1.6

Toe: 6(30.0%);

Forefoot: 5(25.0%);

Midfoot: 7(35.0%);

Ankle/hindfoot: 2(10.0%)

4.7 ± 5.2

Cazzell, 2017 [26]

SOC

69

8.4 ± 1.9

NA

NA

Wagner 1: 14 (20.3%)

Wagner 2: 55 (79.7%)

Dorsal: 15(21.7%);

Plantar: 52(75.4%);

Other: 2(2.9%)

3.6 ± 3.6

36.4 ± 36.4w

D-ADM

71

8.5 ± 1.8

Wagner 1: 12 (16.9%)

Wagner 2: 59 (83.1%)

Dorsal: 12(16.9%);

Plantar: 56(78.9%);

Other: 3(4.2%)

3.9 ± 4.2

40.0 ± 36.4w

GJ-ADM

28

7.6 ± 1.4

Wagner 1: 5 (17.9%)

Wagner 2: 23 (82.1%)

Dorsal: 6(21.4%);

Plantar: 21(75.0%);

Other: 1(3.6%)

3.3 ± 2.7

36.8 ± 53.6w

Zelen, 2018 [27]

SOC

40

7.8 ± 1.5

NA

100%

NA

Toe: 11 (28%);

Forefoot: 18 (45%);

Midfoot: 8 (20%);

Ankle/hindfoot: 3 (7%)

3.2 ± 4.0

> = 4w

SOC + human reticular CDM

40

7.6 ± 1.4

Toe: 13 (33%);

Forefoot: 13 (33%);

Midfoot: 6 (15%);

Ankle/hindfoot: 8 (20%)

2.7 ± 2.4

Tchanque-Fossuo, 2019 [28]

SOC

29

8.6 ± 1.7

1.07 ± 0.14

NA

NA

Dorsal: 3 (15.8%);

Plantar: 15 (79.0%);

Lateral: 1 (5.3%)

1.3 ± 0.9

21.7 ± 36.1w

SOC + cellular Dermagraft

29

7.6 ± 1.5

1.22 ± 0.17

Dorsal: 1 (5.9%);

Plantar: 13 (76.5%);

Lateral: 2 (11.8%);

Medial: 1 (5.9%)

1.6 ± 1.8

37.6 ± 96.1w

SOC + acellular Oasis

31

7.7 ± 1.5

1.10 ± 0.12

Dorsal: 3 (15.8%);

Plantar: 15 (79.0%);

Lateral: 1 (5.3%)

3.1 ± 3.8

10.9 ± 7.6w

Reyzelman, 2009 [29]

SOC

39

7.6 ± 1.6

ranging from 0.7 to 1.2

NA

University of Texas (UT) grade 1 or 2

Toe: 5(12.8%);

Foot: 17(43.6%);

Heel: 8(20.5%);

Other: 3(7.7%)

5.1 ± 4.8

22.9 ± 29.8w

ADM

47

8.2 ± 2.0

Toe: 15(32.6%);

Foot: 15(32.6%);

Heel: 4(8.7%);

Other: 5(10.9%)

3.6 ± 4.3

23.3 ± 22.4w

Hu, 2016 [30]

SOC + STSG

26

10.2 ± 1.1

0.9 ± 0.2

NA

Wagner grade 2 or 3

Ankle: 4 (15.4%);

Dorsal: 6 (23.1%);

Plantar: 7 (26.9%);

Forefoot: 5 (19.2%);

Heel: 4 (15.4%)

28.6 ± 25.2

25.0 ± 33.9w

SOC + STSG + human ADM

26

9.8 ± 1.5

1.0 ± 0.2

Ankle: 6 (23.1%);

Dorsal: 7 (26.9%);

Plantar: 7 (26.9%);

Forefoot: 2 (7.7%);

Heel: 4 (15.4%)

32.1 ± 22.2

29.4 ± 41.7w

Lantis, 2021 [31]

SOC

104

8.3 ± 1.8

NA

59.6%

NA

Dorsal: 24 (23.1%);

Plantar: 80 (76.9%)

3.8 ± 2.8

233.1 ± 312.9d

Graftskin

103

8.1 ± 1.9

50.5%

Dorsal: 25 (24.2%);

Plantar: 78 (75.8%)

3.6 ± 2.5

263.9 ± 514.5d

Veves, 2001 [32]

SOC (saline-moistened gauze)

96

8.6 ± 1.4

0.65–0.80: 10 (10.4%);

0.80–1.00: 29 (30.2%);

> 1.00: 54 (56.3%)

100%

NA

Plantar: 100%

2.8 ± 2.5

11.1 ± 12.5 m

Graftskin

112

8.6 ± 1.5

0.65–0.80: 10 (8.9%);

0.80–1.00: 50 (35.7%);

> 1.00: 59 (52.7%)

3.0 ± 3.1

11.5 ± 13.3 m

Hahn, 2021 [33]

SOC (NPWT)

15

8.2 ± 2.4

0.8 ± 0.7

50.0%

Wagner grade 2 or higher

Ankle: 2(14.3%);

Dorsal: 4 (28.6%);

Plantar: 2 (14.3%);

Forefoot: 3 (21.4%);

Heel: 3 (21.4%)

13.1 ± 22.2

1–3 m: 5;

3-6 m: 7;

> 6 m: 2

NPWT + micronized dermal matrix

15

7.1 ± 1.8

0.7 ± 0.6

60.0%

Ankle: 3 (20.0%);

Dorsal: 2 (13.3%);

Plantar: 3 (20.0%);

Forefoot: 4 (26.7%);

Heel: 3 (20.0%)

16.3 ± 10.3

1–3 m: 4;

3-6 m: 8;

> 6 m: 3

Cazzell, 2015 [34]

SOC

41

NA

NA

100%

NA

Plantar: 100%

2.6 ± 7.5

22.2 ± 13.5w

tri-layer porcine SIS

41

NA

2.1 ± 2.3

21.3 ± 12.3w

Brigido, 2006 [35]

SOC (sharp debridement)

14

7.9 ± 0.6

NA

NA

Wagner grade 2

Plantar: 4(28.6%);

Dorsal: 3(21.4%);

Medial: 2(14.3%);

Lateral: 3(21.4%);

Other: 2(14.3%)

NA

NA

SOC + Graftjacket tissue matrix

14

8.1 ± 1.0

Plantar: 5(35.7%);

Dorsal: 3(21.4%);

Medial: 5(35.7%);

Other: 1(7.1%)

Campitiello, 2017 [36]

SOC (wet dressing)

23

7.8 ± 0.8

Right: 0.94 ± 0.1;

Left: 0.93 ± 0.1

NA

Wagner grade 3

Abscesses foot: 16 (69.6%);

Heel: 2 (8.7%);

Metatarsal head: 5 (21.7%)

NA

39.5 ± 9.9w

Integra Flowable Wound Matrix

23

7.9 ± 0.8

Right: 0.92 ± 0.1

Left: 0.92 ± 0.1

Abscesses foot: 18 (78.3%);

Heel: 1 (4.4%);

Metatarsal head: 4 (17.4%)

38.56 ± 12.6w

  1. SOC standard of care, IDRT Integra Dermal Regeneration Template, NA not available, ADM acellular dermal matrix, CDM cellular dermal matrix, D-ADM DermACELL acellular dermal matrix, GJ-ADM GraftJacket acellular dermal matrix, STSG split-thickness skin grafting, NPWT negative-pressure wound therapy, SIS small intestine submucosa, ABI ankle-brachial index, DPN diabetic polyneuropathy