Table 3 Treatment details of the included studies
Study ID | Interventions | Screening phase | Treatment phase | ||
|---|---|---|---|---|---|
Treatment regimen | screening criterion | Intervention regimen | Dermal matrix product | ||
Brigido, 2004 [22] | SOC | No screening phase | sharp debridement, wound gel with gauze dressings, offloading | Craftjacket tissue matrix (Wright Medical Technology, Inc., Arlington, Tenn) | |
GraftJacket tissue matrix | surgical application of scaffold at day 0 | ||||
Driver, 2015 [23] | SOC | 1) period: 2w; 2) treatment: infection and exudate management, sharp debridement, moist wound therapy, offloading device | ≤30% reduction in ulcer site | sharp debridement, moist wound therapy, offloading | Integra Dermal Regeneration Template (IDRT; marketed as Omnigraft Dermal Regeneration Matrix) |
SOC + IDRT | IDRT was applied to the debrided wound, trimmed to size and secured with sutures or staples | ||||
Cazzell, 2019 [24] | SOC + ADM allograft | 1) period: 1w; 2) treatment: surgical debridement, offloading device, NPWT | none | surgical debridement, offloading, NPWT, Meshed 4*4 cm and 5*7 cm D-ADM were attached onto wound | DermACELL (D-ADM; LifeNet Health, Virginia Beach, Virginia) |
Zelen, 2016 [25] | SOC | 1) period: 2w; 2) treatment: surgical debridement, wound dressing, offloading device | ≤20% reduction in ulcer site | surgical debridement, offloading, wound dressing | AlloPatch® Pliable™ (Musculoskeletal Transplant Foundation, Edison, NJ, USA) |
SOC + human reticular CDM | HR-ADM provided in size-specific grafts as small as 1.5*1.5 cm | ||||
Cazzell, 2017 [26] | SOC | No screening phase | sharp debridement, moist wound treatment, off-loading | – | |
D-ADM | meshed 4 × 4 cm (thickness: 0.5–1.0 mm) D-ADM | DermACELL; LifeNet Health, Virginia Beach, VA | |||
GJ-ADM | meshed 4 × 4 cm (thickness: 0.38–1.02 mm) GJ-ADM | GraftJacket; Wright Medical Technology, Memphis, TN | |||
Zelen, 2018 [27] | SOC | 1) period: 2w; 2) treatment: sharp debridement, wound dressing, offloading device | ≤20% reduction in ulcer site | wound dressing, offloading | AlloPatch Pliable (MTF, Musculoskeletal Transplant Foundation, Edison, New Jersey) |
SOC + human reticular CDM | provided in sizes as small as 1.5 × 1.5 cm to optimize donor tissue | ||||
Tchanque-Fossuo, 2019 [28] | SOC | 1) period: 2w; 2) treatment: debridement, SOC dressing, offloading device, infection management | ≤40% reduction in ulcer site | SOC wound dressing | – |
SOC + cellular Dermagraft | NA | Dermagraft (bioengineered ECM containing living fibroblasts) | |||
SOC + acellular Oasis | NA | Oasis (ECM devoid of living cells) | |||
Reyzelman, 2009 [29] | SOC | No screening phase | moist-wound therapy, debridement, offloading | GraftJacket Regenerative Tissue Matrix – Ulcer Repair; Wright Medical Technology, Inc., Arlington, TN | |
ADM | application of a human ADM (4*4 cm) | ||||
Hu, 2016 [30] | SOC + STSG | No screening phase | patient education, glucose control, off-loading, wound moist treatment, debridement, infection control | human allograft ADM purchased from Jie-Ya Life Tissue Engineering (Beijing, China) | |
SOC + STSG + human ADM | ADM was implanted onto the debrided wounds as a scaffold and covering | ||||
Lantis, 2021 [31] | SOC | 1) period: 2w; 2) treatment: sharp debridement, infection elimination, moist wound dressing, offloading device, infection management | ≤30% reduction in ulcer site | sharp debridement, infection elimination, moist wound dressing, offloading device, infection management | fetal bovine dermis (FBADM) (PriMatrix, Integra LifeSciences, Princeton, US) |
Graftskin | meshed 4 × 4 cm graft placed in direct contact with a freshly debrided wound | ||||
Veves, 2001 [32] | SOC (saline-moistened gauze) | 1) period: 1w; 2) treatment: aggressive debridement, saline-moistened gauze | ≤30% reduction in ulcer site | moist-wound therapy, off-loading | Graftskin (Apligraf; Organogenesis, Canton, MA, and Novartis Pharmaceuticals, East Hanover, NJ) |
Graftskin | Graftskin was placed directly over the ulcer site | ||||
Hahn, 2021 [33] | SOC (NPWT) | No screening phase | surgical debridement, NPWT | MHADM (CG-PASTE; CGBio Co Ltd) | |
NPWT + micronized dermal matrix | MHADM was molded to fit three-dimensional shape of wound | ||||
Cazzell, 2015 [34] | SOC | 1) period: 1w; 2) treatment: debridement, callus resection, offloading device | none | wound care/dressings | tri-layer porcine SIS (OASISUltra; Cook Biotech, Inc., West Lafayette, IN; exclusively marketed by Smith and Nephew, Inc., Fort Worth, TX) |
tri-layer porcine SIS | SIS was applied once each week to ulcers. The matrix was cut so that there was an approximate 1/8 in. overlap on the wound edge | ||||
Brigido, 2006 [35] | SOC (sharp debridement) | No screening phase | sharp debridement, off-loading, wound dressing | Graftjacket (Wright Medical Technology, Inc., Arlington, TN, USA) | |
SOC + Graftjacket tissue matrix | GraftJacket was prepared for implantation | ||||
Campitiello, 2017 [36] | SOC (wet dressing) | No screening phase | sharp debridement, removable off-loading, wound dressing | Integra Flowable Wound Matrix, Integra LifeScience Corp, Plainsboro, NJ, USA | |
Integra Flowable Wound Matrix | the matrix Integra TM Flowable Wound Matrix was applied to the lesion, using the flexible injector | ||||