Randomized Clinical Trial to Compare Cryopreserved and Lyopreserved Umbilical Cord Tissue to Treat Complex Diabetic Foot Wounds.

Abstract

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.