TY - JOUR
T1 - Randomized Clinical Trial to Compare Cryopreserved and Lyopreserved Umbilical Cord Tissue to Treat Complex Diabetic Foot Wounds
AU - Lavery, Lawrence A.
AU - Suludere, Mehmet A.
AU - Johnson, Matthew J.
AU - Killeen, Amanda L.
AU - Raspovic, Katherine M.
AU - Crisologo, Peter A.
AU - Tarricone, Arthur N.
N1 - Publisher Copyright:
© The Author(s) 2024.
PY - 2024
Y1 - 2024
N2 - To compare the incidence of infection, wound closure and time to wound closure in patients treated with cryopreserved (CPUT) and lyopreserved umbilical tissue (LPUT) in complex diabetic surgical wounds. This single-blinded 12-week randomized clinical trial compared cryopreserved and lyopreserved amniotic cord tissue to treat complex diabetic foot wounds. LPUT or CRAT was applied at baseline and again after four weeks. We enrolled subjects with UT2A-D and 3A-D wounds (depth to tendon, muscle, or bone with infection and/or PAD) and excluded subjects with ABI < 0.5 or TBI < 0.3, untreated osteomyelitis, and autoimmune diseases. We used a 3-D camera to evaluate wound area and volume. The mean baseline wound areas were 12.9 ± 10.7 cm2 for CPUT and 11.7 ± 7.0 cm2 for LPUT. The mean baseline wound volume was 7.5 ± 8.1 for CPUT and 9.2 ± 10.2 cm3 for LPUT. There was no difference between CPUT and LPUT in wound closure (36.8% vs 19.0%, P =.21) or infection (10.5% vs 4.8%, P =.60). There was no difference in mean wound area reduction between CPUT and LPUT (75.9 ± 32.3% vs 65.5 ± 38.4%, P =.41), nor in mean volume reduction (85.0 ± 30.8% vs 79.9 ± 31.9%, P =.61). In addition, there was no difference in wound closure trajectories for changes in area (P =.75) or volume (P =.43). Cryopreserved and lyopreserved amniotic tissue provided similar results in patients with complex diabetic foot wounds.
AB - To compare the incidence of infection, wound closure and time to wound closure in patients treated with cryopreserved (CPUT) and lyopreserved umbilical tissue (LPUT) in complex diabetic surgical wounds. This single-blinded 12-week randomized clinical trial compared cryopreserved and lyopreserved amniotic cord tissue to treat complex diabetic foot wounds. LPUT or CRAT was applied at baseline and again after four weeks. We enrolled subjects with UT2A-D and 3A-D wounds (depth to tendon, muscle, or bone with infection and/or PAD) and excluded subjects with ABI < 0.5 or TBI < 0.3, untreated osteomyelitis, and autoimmune diseases. We used a 3-D camera to evaluate wound area and volume. The mean baseline wound areas were 12.9 ± 10.7 cm2 for CPUT and 11.7 ± 7.0 cm2 for LPUT. The mean baseline wound volume was 7.5 ± 8.1 for CPUT and 9.2 ± 10.2 cm3 for LPUT. There was no difference between CPUT and LPUT in wound closure (36.8% vs 19.0%, P =.21) or infection (10.5% vs 4.8%, P =.60). There was no difference in mean wound area reduction between CPUT and LPUT (75.9 ± 32.3% vs 65.5 ± 38.4%, P =.41), nor in mean volume reduction (85.0 ± 30.8% vs 79.9 ± 31.9%, P =.61). In addition, there was no difference in wound closure trajectories for changes in area (P =.75) or volume (P =.43). Cryopreserved and lyopreserved amniotic tissue provided similar results in patients with complex diabetic foot wounds.
KW - diabetic foot ulcers
KW - infection
KW - lower extremity wound
KW - umbilical cord tissue
KW - wound
UR - https://www.scopus.com/pages/publications/85211779017
UR - https://www.scopus.com/pages/publications/85211779017#tab=citedBy
U2 - 10.1177/15347346241273282
DO - 10.1177/15347346241273282
M3 - Article
C2 - 39636039
AN - SCOPUS:85211779017
SN - 1534-7346
JO - International Journal of Lower Extremity Wounds
JF - International Journal of Lower Extremity Wounds
ER -