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

Authors

Lawrence A. Lavery, University of Texas Southwestern Medical Center
Mehmet A. Suludere, University of Texas Southwestern Medical Center
Matthew J. Johnson, University of Texas Southwestern Medical Center
Amanda Killeen, The University of Texas Rio Grande ValleyFollow
Katherine M. Raspovic, University of Texas Southwestern Medical Center
Peter A. Crisologo, University of Texas Southwestern Medical Center
Arthur Tarricone, University of Texas Health Science Center at San Antonio

Document Type

Article

Publication Date

12-5-2024

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.

Comments

© The Author(s) 2024

Recommended Citation

Lavery, L. A., Suludere, M. A., Johnson, M. J., Killeen, A. L., Raspovic, K. M., Crisologo, P. A., & Tarricone, A. N. (2024). Randomized Clinical Trial to Compare Cryopreserved and Lyopreserved Umbilical Cord Tissue to Treat Complex Diabetic Foot Wounds. The International Journal of Lower Extremity Wounds, 15347346241273282. https://doi.org/10.1177/15347346241273282

Creative Commons License

This work is licensed under a Creative Commons Attribution 4.0 International License.

Publication Title

The International Journal of Lower Extremity Wounds

Academic Level

faculty

DOI

https://doi.org/10.1177/15347346241273282