Experience with a Lyopreserved Placental Membrane in Diabetic Foot Wounds

Introduction: Placental-derived tissue products have been widely utilized in wound healing and regeneration as their extracellular matrix (ECM) composition facilitates cell migration, proliferation, angiogenesis, and remodeling. [1]  Placental-membrane (PM) products have subsequently flourished on the market, but designs, placental sources, storage methods, and preservation techniques vary, with some rendering the PM decellularized, potentially decreasing anti-inflammatory, antimicrobial, and angiogenic effects. [2]  Lyopreservation is an innovative technique that maintains the PM ECM scaffold while preserving growth factors and living viable cells and allows for room temperature product storage. We chose to evaluate the efficacy of a novel, lyopreserved PM (LPM*) in a small group of patients with chronic DFUs.Methods:Five diabetic patients with eight wounds were seen weekly in our offices. At every visit, patients underwent debridement and irrigation with a wound-cleansing solution followed by application of LPM*. After application, a nonstick dressing was applied overlying, followed by an offloading device. At each visit, wound health and wound area was recorded.Results:Patients had an average initial area of 6.6cm2  and underwent an average of 3.5 LPM applications. Among those who remained in the study, wounds had an average weekly area reduction of 40%. One patient had 88.6% WAR after two LPM* applications and he closed after three.   One patient showed a positive trajectory initially, but after three applications, his wound started to decline and after the 4th application, he developed clinical signs of infection. One patient with 2 DFUs, one on his lateral foot from inadequate offloading and one plantar DFU that highly stagnant. After 1 LPM* application, his plantar and lateral DFU decreased by 50% and 87.5%, respectively. After 2 applications, his lateral DFU closed. His plantar wound decreased by 83.3% by 6 applications. Another patient with a recalcitrant DFU achieved 39.6% closure after two LPM* applications. Another patient with a history of renal transplant, critical limb ischemia s/p revascularization, and osteomyelitis s/p several metatarsal amputations underwent 4 applications of LPM* with good initial results but then developed breakdown and pressure necrosis from intermittent noncompliance with offloading. He eventually underwent BKA. Discussion: LPM* can promote wound area reductions and closures in DFUs. Based on our limited experience, the LPM* is more effective in smaller wounds and those of solely diabetic etiology. The LPM* appears less effective in larger and deeper DFUs and in patients with comorbidities that affect wound healing, though this observation may be due to our small sample size.References:1. Protzman NM, Mao Y, Long D, Sivalenka R, Gosiewska A, Hariri RJ, Brigido SA. Placental-Derived Biomaterials and Their Application to Wound Healing: A Review. Bioengineering. 2023; 10(7):829. https://doi.org/10.3390/bioengineering10070829 2. Regulski MJ, Danilkovitch A, Saunders MC. Management of a chronic radiation necrosis wound with lyopreserved placental membrane containing viable cells [published correction appears in Clin Case Rep. 2019 Aug 14;7(8):1623-1624]. Clin Case Rep. 2019;7(3):456-460. Published 2019 Jan 28. doi:10.1002/ccr3.2011