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. 2020 Mar 2;17(3):753–764. doi: 10.1111/iwj.13318

Table 1.

General characteristics of included studies

Author/year Universal trial number Mean age (years) /(SD) BMI (kg/m2)/(SD) HbA1c (%) Ulcer size (cm2)/(SD) Ulcer location Intervention (brand and case number) Type of HAM (processing method) Control (case number) Duration of follow‐up
Zelen et al (2013) NCT01552499 I = 56.4 (14.7) C = 61.7 (10.3) I = 30.4 (5.7) C = 35.4 (6.6) Not mentioned I = 2.6 (1.9) C = 3.4 (2.9) Forefoot, digital, heel and midfoot dHACM (EpiFix®, MiMedx, Kennesaw, GA) + SOC (n = 13) Amnion and chorion (Dehydration) SOC (n = 12) 12 weeks or until complete healing
Lavery et al (2014) Not mentioned I = 55.5 (11·5) C = 55.1 (12·0) I = 33.5 (7.7) C = 32.2 (7.9) I = 8.0 (1.6) C = 7.8 (1.5) I = 3.41 (3.23) C = 3.93 (3.22) Dorsal and plantar hVWM (Grafix® Osiris Therapeutics, Inc., Columbia, MD) + SOC3(n = 50) Amnion and chorion (cryopreservation) SOC (n = 47) 12 weeks
Mohajeri‐Tehrani et al (2016) Not mentioned I = 55.44 (11.27) C = 60.00 (9.30) I = 29.30 (7.06) C = 27.4 (5.21) I = 7.4 (1·1) C = 7.5 (1·1) I = 9.48 (9.35) C = 8.61 (10.05) Toe, heel, plantar, forefoot, lateral maleol AHAM (Life Patch, International Bioimplant Company, Tehran, Iran) + SOC (n = 27) Amnion (Cryopreservation) SOC (n = 30) 6 weeks
Snyder et al (2016) NCT02209051 I = 57.9 (12.49) C = 58.6 (6.97) I = 34.9 (5.9) C = 35.1 (8.1) Not mentioned I = 4.7 (5.43) C = 6.9 (6.75) Forefoot, hindfoot, metatarsals, midfoot, Phalanges DAMA (AMNIOEXCEL, Derma Sciences Inc, Princeton, NJ) + SOC (n = 15) Amnion (Dehydration) SOC (n = 14) 6 weeks
Zelen et al (2016) NCT01921491 I = 63.3 (12.25); C = 60.6 (11.55) I = 33.9 (6.99); C = 34.7 (9.35) I = 7.5 (1.51); C = 8.2 (1.78)

I = 2.6 (2.97);

C = 3.1 (3.17)

Toe, forefoot, midfoot, hindfoot, ankle dHACM 2 (EpiFix®, MiMedx Group Inc., Marietta, GA) + SOC (n = 32) Amnion and chorion (dehydration) SOC3 (n = 35) 12 weeks or until 1 week after complete healing
DiDomenico et al (2018) NCT02399826 I = 60.1 (11.77); C = 61.0 (10.66) I = 34.0 (9.30); C = 34.5 (9.42) I = 7.6 (1.47); C = 7.9 (1.48) I = 2.1 (1.46); C = 3.1 (3.58); Toe, forefoot, midfoot, heel, ankle, hindfoot dHACA (AmnioBand, Musculoskeletal Transplant Foundation, Edison, NJ) + SOC (n = 40) Amnion and chorion (dehydration) SOC (n = 40) 12 weeks
Tettelbach et al (2019) NCT01693133 I = 57.4 (10.6); C = 57.1 (10.5) I = 35.8 (8.9); C = 34.6 (8.5) I = 7.8 (1.4); C = 8.8 (1.8) I = 3.2 (2.8); C = 3.9 (3.8) Toe, forefoot, midfoot, ankle, hindfoot dHACM (EpiFix, MiMedx Group Inc., Marietta, GA) + SOC (n = 54) Amnion and chorion (dehydration) SOC (n = 56) 12 weeks
Thompson et al (2019) NCT02344329 I = 58.50 (12.96); C = 55.17 (18.32) Not mentioned I = 9.63 (2.77); C = 8.47 (2.44) I = 1.54 (1.74); C = 2.78 (3.04) Not mentioned HAA (AmnioExcel; Integra Lifesciences, Plainsboro, New Jersey) + SOC + TCC (TCC‐EZ; Derma Sciences Inc, Plainsboro, New Jersey) (n = 7) Amnion (Dehydration) SOC + TCC (n = 6) 12 weeks or until complete healing
Serena et al. 2019 Not mentioned I = 59.2 (7.61); C = 59.6 (10.72) Not mentioned Not mentioned I = 3.12 (3.86); C = 3.33 (4.62) Not mentioned HSAM + SOC + TCC (n = 38) Amnion (Cryopreservation) SOC + TCC (n = 38) 16 weeks

Abbreviations: AHAM, acellular human amniotic membrane; DAMA, dehydrated amniotic membrane allograft; dHACA, dehydrated human amnion and chorion allograft; dHACM, dehydrated human amnion/chorion membrane allograft; HAA, human amniotic allograft; HAM, human amniotic membrane; hVWM, human viable wound matrix; HSAM, hypothermically stored amniotic membrane; TCC, total contact casts; SOC, standard of care.