Table 1 Characteristics of the included studies
Study ID | Study period | Country | Interventions | No. of patients | Male% | Mean age-years | Mean BMI | Diabetes type | Length of diabetes | Follow-up time | Dropped patients |
|---|---|---|---|---|---|---|---|---|---|---|---|
Brigido, 2004 [22] | 2003.4–2003.6 | USA | SOC | 20 | 77.5 | Median: 58 (range: 43–70) | NA | NA | NA | weekly for 4 weeks | 0 |
GraftJacket tissue matrix | 20 | NA | NA | NA | 0 | ||||||
Driver, 2015 [23] | 2010.4–2013.11 | USA | SOC | 153 | 74.5 | 57.3 ± 9.7 | 34.1 ± 8.4 | NA | NA | up to 16 weeks or until 100% wound closure | 71 |
SOC + IDRT | 154 | 76.6 | 55.8 ± 10.6 | 34.0 ± 7.2 | NA | NA | 48 | ||||
Cazzell, 2019 [24] | NA | USA | SOC + ADM allograft | 61 | 75.4 | 55.2 ± 11.8 | 32.9 ± 7.4 | I: 4.9%; II: 90.2%; Pre-D: 4.9% | NA | weekly for 16 weeks | 14 |
Zelen, 2016 [25] | 2014.12–2015.11 | USA | SOC | 20 | 60.0 | 57.1 ± 10.7 | 32.3 ± 6.9 | NA | NA | weekly for 12 weeks | 3 |
SOC + human reticular CDM | 20 | 80.0 | 61.5 ± 10.9 | 33.9 ± 8.7 | NA | NA | 1 | ||||
Cazzell, 2017 [26] | NA | USA | SOC | 69 | 73.9 | 56.9 ± 10.9 | 32.8 ± 6.9 | I: 2.9%; II: 97.1% | NA | 24 weeks with major endpoints at weeks 12, 16, and 24 | 13 |
D-ADM | 71 | 80.3 | 59.1 ± 12.8 | 32.6 ± 8.3 | I: 5.6%; II: 90.1% | NA | 18 | ||||
GJ-ADM | 28 | 71.4 | 58.5 ± 9.8 | 31.4 ± 5.1 | I: 7.1%; II: 92.9% | NA | 5 | ||||
Zelen, 2018 [27] | 2014.12–2017.3 | USA | SOC | 40 | 70.0 | 59 .0 ± 12.0 | 35.0 ± 7.9 | NA | NA | weekly for 16 weeks or until 100% wound closure | 0 |
SOC + human reticular CDM | 40 | 60.0 | 62.0 ± 13.0 | 34.0 ± 8.8 | NA | NA | 0 | ||||
Tchanque-Fossuo, 2019 [28] | 2011.10–2016.8 | USA | SOC | 29 | 89.5 | 63.3 ± 9.1 | 36.5 ± 6.6 | NA | NA | 28w: 8-week treatment phase + 4-week maintenance phase + 4 monthly visits | 8 |
SOC + cellular Dermagraft | 29 | 100.0 | 62.8 ± 9.0 | 32.4 ± 5.3 | NA | NA | 7 | ||||
SOC + acellular Oasis | 31 | 94.7 | 61.9 ± 8.6 | 36.5 ± 11.6 | NA | NA | 9 | ||||
Reyzelman, 2009 [29] | NA | USA | SOC | 39 | NA | 58. 9 ± 11.6 | 34.6 ± 8.5 | I: 5.1%; II: 94.9% | NA | up to 12 weeks or until 100% wound closure | 2 |
ADM | 47 | NA | 55.4 ± 9.6 | 34.6 ± 6.7 | I: 10.9%; II: 89.1% | NA | 5 | ||||
Hu, 2016 [30] | 2010.9–2013.11 | China | SOC + STSG | 26 | 34.6 | 61.7 ± 12.1 | NA | II: 100% | 11.8 ± 7.8y | for 12 months after grafting surgery | 2 |
SOC + STSG + human ADM | 26 | 42.3 | 66.6 ± 12.7 | NA | II: 100% | 15.0 ± 8.7y | 1 | ||||
Lantis, 2021 [31] | NA | USA | SOC | 104 | 80.6 | 58.5 ± 11.9 | 32.2 ± 7.6 | I: 6.7%; II: 93.3% | NA | weekly for 12 weeks or until 100% wound closure | 22 |
Graftskin | 103 | 76.9 | 57.6 ± 11.5 | 33.3 ± 7.6 | I: 10.7%; II: 89.3% | NA | 24 | ||||
Veves, 2001 [32] | NA | USA | SOC (saline-moistened gauze) | 96 | 77.2 | 56.0 ± 10.0 | 33.1 ± 7.7 | NA | NA | efficacy evaluation for 12 weeks + safety evaluation for another 3 months | 22 |
Graftskin | 112 | 79.2 | 58.0 ± 10.0 | 30.9 ± 6.5 | NA | 22 | |||||
Hahn, 2021 [33] | 2016.4–2016.12 | Korea | SOC (NPWT) | 15 | 71.4 | 59.9 ± 13.4 | NA | NA | 16.3 ± 10.3y | every other day for 6 months or until 100% wound closure | 0 |
NPWT + micronized dermal matrix | 15 | 73.3 | 63.5 ± 12.9 | NA | NA | 22.5 ± 14.7y | 1 | ||||
Cazzell, 2015 [34] | 2013.5–2014.7 | USA | SOC | 41 | 73.0 | 56.6 ± 10.8 | NA | NA | NA | up to 12 weeks or until 100% wound closure | 4 |
tri-layer porcine SIS | 41 | 78.0 | 57.1 ± 10.9 | NA | NA | NA | 0 | ||||
Brigido, 2006 [35] | NA | USA | SOC (sharp debridement) | 14 | NA | 66.2 ± 4.4 | NA | NA | NA | up to 16 weeks | 0 |
SOC + Graftjacket tissue matrix | 14 | NA | 61.4 ± 7.2 | NA | NA | NA | 0 | ||||
Campitiello, 2017 [36] | NA | Italy | SOC (wet dressing) | 23 | 56.5 | 62.1 ± 7.7 | 28.9 ± 2.7 | NA | NA | weekly for 6 weeks or until 100% wound closure | 0 |
Integra Flowable Wound Matrix | 23 | 65.2 | 64.0 ± 8.9 | 28.5 ± 2.5 | NA | NA | 0 |