SLR - April 2019 - Nicholas Salerno

Effectiveness of Viable Cryopreserved Placental Membranes for Management of Diabetic Foot Ulcers in a Real-World Setting

Reference: Raspovic K.M., Wukich D.K., Naiman D.Q., Lavery L.A., Kirsner R.S., Kim P.J. Effectiveness of viable cryopreserved placental membranes for management of diabetic foot ulcers in a real-world setting. Wound Repair Regen, 2018.

Scientific Literature Review

Reviewed by:
Nicholas Salerno, DPM
Residency Program: Medstar Georgetown Hospital Center, Washington, DC

Podiatric Relevance:
Diabetic foot ulcerations (DFU) are the most common and serious complication of diabetes, and they ultimately affect one's quality of life by increasing risk for infection, amputation and death. With good wound care (debridement, infection control, moist dressing and offloading), roughly 70 percent of DFUs remain unhealed after 20 weeks. Placental membrane-derived grafting in wound care centers are used for anti-inflammatory, antimicrobial, antifibrotic and angiogenic properties to support wound healing as advanced wound care products (AWCPs). This study aims to evaluate the effectiveness of viable cryopreserved placental membranes (vCPM) in DFUs in the average physician practice.

Methods: The study is a retrospective analysis of the effectiveness of vCPM (Grafix PRIME and Grafix CORE, Osiris Therapeutics, Inc., Columbia, MD) in DFUs utilizing the Net Health’s WoundExpert HER database. A total of 360 patients with 441 wounds were analyzed to assess wound closure, time to closure, number of graft applications and proportions of wounds with more than 50 percent area reduction by Week 4.
Results: After exclusion criteria, wounds larger than or equal to 0.25 cm2, 350 wounds treated with vCPM were evaluated and analyzed. The mean prior wound size measured 5.1 cm2 with a depth of 3.9 mm; 15 percent of wounds having exposed bone or probing to joint spaces. These wounds had a mean duration of 102 days with good wound care. After AWCP with vCPM, 59.4 percent achieved complete closure in a median time of 42 days, and with four vCPM applications. The probability of wound closure at 12 weeks was then estimated to be 71 percent calculated using Kaplan-Meier’s method.

Conclusions: The authors concluded that vCPM had a positive benefit in chronic DFUs, which fail to resolve with basic clinical wound care, due to confounding comorbidities. 59.3 percent of wounds showed closure at a median of 42 days, and 67.6 percent of the 142 unhealed wounds showed a reduction in size by more than 50 percent. This shows that basic wound care techniques with skin substitutes like vCPM are able to help us modify our current practices in wound management.

Due to the difficulty of managing DFUs and consequences that coincide with them, understanding the basis of wound care is paramount. Debridement, infection control, moist dressing and offloading are key; however, in patients with varying comorbidities, these tools are often not enough to achieve complete wound closure. This study gives us a timeline to adequately assess a wound's healing potential and percentage of reduction expected. Based on their study on transitioning to vCPM, it has the ability to facilitate closure and allows us to predict roughly an overall healing time for wounds based on their clinical size. These concepts help providers change treatment plans and prevent unneeded infections, amputations and patient anxiety. As studies continue, the wound care field will slowly evolve and will hopefully develop better algorithms in DFU treatment. 

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