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.