Table 1 Summary of the included studies
Study ID | Study design NCT | Sample Size | Follow-up duration | Definition of ulcers | Intervention applied | |||
|---|---|---|---|---|---|---|---|---|
Amniotic membrane products | Components | Processing method | Application | |||||
DiDomenico et al. 2016 | RCT NCT02399826 | 40 | 12Â weeks | Ulcer with a size larger than 1Â cm present for a minimum of 4wk duration, with no signs of infection | (Amnio Band, Musculoskeletal Transplant Foundation) | Amnion and chorion | Dehydrated | Graft |
DiDomenico et al. 2018 | RCT NCT02399826 | 80 | 12Â weeks | Ulcer with a size larger than 1cm2 present for a minimum of 4wk duration, with no signs of infection | (Amnio Band Membrane, MTF) | Amnion and chorion | Dehydrated | Graft |
Lavery et al. 2014 | RCT N/A | 97 | 12Â weeks | Wound present between 4 and 52Â weeks, wound located below the malleoli on plantar or dorsal surface of the foot and ulcer between 1 and 15 cm2 | Grafix | Amnion/ chorion | Cryposervation | N/A |
Zelen et al. 2013 | RCT NCT01552499 | 25 | 12 weeks | Ulcer size > 1 and ulcer duration of ≥ 4 weeks; no clinical signs of infection | EpiFix | Amnion | Dehydrated | Graft |
Knowlton et al | RCT NCT03547635 | 78 | 12 weeks | Ulcer size (i.e., area) is > 1 cm2 and < 12 cm2 | AMNIOEXCEL | Amnion and chorion | Dehydrated | Graft |
Serena et al. 2019 | RCT N/A | 76 | 16Â weeks | Ulcer between 1 and 25 cm2 | N/A | Amnion | Hypothermically | Graft |
Snyder et al. 2016 | RCT NCT02209051 | 29 | 6Â weeks | The Wound that located superficially on the foot, distal to malleolus, Wagner grade 1 or 2, has a duration of at least 1Â month with no clinical signs of infection or osteomyelitis, and between 1 cm2 and 25 cm2 in area | N/A | Amnion | Dehydrated | Graft |
Tettelbach et al. 2019 | RCT NCT01693133 | 110 | 12 weeks | Ulcer size ≥ 1 cm2 and < 25 cm2 and Ulcer duration of ≥ 4 weeks, unresponsive to standard wound care | N/A | Amnion and chorion | Dehydrated | Graft |
Thompson et al. 2019 | RCT N/A | 13 | 12Â weeks | Ulcer located on the plantar surface larger than 0.5 cm2 | (Amnio Excel; Integra Lifesciences, Plainsboro, New Jersey) | Amnion | Dehydrated | Graft |
Zelen et al. 2014 | RCT NCT01921491 | 40 | 12 weeks | Ulcer size > 1 and < 25 cm2; ulcer duration of ≥ 4 weeks; no clinical signs of infection | EpiFix | Amnion and chorion | Dehydrated | Graft |
Zelen et al. 2016 | RCT NCT01921491 | 67 | 12 weeks | Ulcer size ≥ 1 and < 25 cm2.Ulcer duration of ≥ 4 weeks, unresponsive to standard wound care, no clinical signs of infection | EpiFix | Amnion and chorion | Dehydrated | Graft |