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. 2020 Dec;17(6):1893-1901.
doi: 10.1111/iwj.13479. Epub 2020 Aug 21.

Lyopreserved amniotic membrane is cellularly and clinically similar to cryopreserved construct for treating foot ulcers

Kathryn E Davis  1 , Amanda L Killeen  1 , David Farrar  2 , Katherine M Raspovic  3 , Zachary D Berriman-Rozen  1 , Matthew Malone  4 , Lawrence A Lavery  1
Affiliations

Lyopreserved amniotic membrane is cellularly and clinically similar to cryopreserved construct for treating foot ulcers

Kathryn E Davis et al. Int Wound J. 2020 Dec.

Abstract

We compared cellular viability between cryopreserved and lyopreserved amniotic membranes and clinical outcomes of the lyopreserved construct in a prospective cohort study of 40 patients with neuropathic foot ulcers. Patients received weekly application of lyopreserved membrane for 12 weeks with standard weekly debridement and offloading. We evaluated the proportion of foot ulcers that closed, time to closure, closure trajectories, and infection during therapy. We used chi-square tests for dichotomous variables and independent t-tests for continuous variables with an alpha of α = .10. Cellular viability was equivalent between cryo- and lyopreserved amniotic tissues. Clinically, 48% of subjects' wounds closed in an average of 40.0 days. Those that did not close were older (63 vs 59 years, P = .011) and larger ulcers at baseline (7.8 vs 1.6 cm2 , P = .012). Significantly more patients who achieved closure reached a 50% wound area reduction in 4 weeks compared with non-closed wounds (73.7% vs 47.6%, P = .093). There was no difference in the slope of the wound closure trajectories between closed and non-closed wounds (0.124 and 0.159, P = .85), indicating the rate of closure was similar. The rate of closure was 0.60 mm/day (SD = 0.47) for wounds that closed and 0.50 mm/day (SD = 0.58) for wounds that did not close (P = .89).

Keywords: amniotic membrane; diabetic foot ulcer; infection; neuropathy.

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Conflict of interest statement

Kathryn E. Davis has received research funding from EO2 Concepts, Inc.; Smith+Nephew; Integra; Cardinal Health, Astra Zeneca, Avazzia, and Pluristem.

Amanda L. Killeen has received research funding from EO2 Concepts, Inc.; Smith+Nephew; Integra; Cardinal Health, Astra Zeneca, Avazzia, and Pluristem.

David Farrar and Zachary D. Berriman‐Rozen declare no conflicts of interest.

Katherine M. Raspovic has received funding from Smith+Nephew and has consulted for Orthofix.

Matthew Malone has received funding from Medline Industries.

Lawrence A. Lavery has received research funding from EO2 Concepts, Inc.; Smith+Nephew; Integra; Cardinal Health, Astra Zeneca, Avazzia, and Pluristem.

Figures

FIGURE 1
FIGURE 1
Live/dead staining of cryopreserved (above) and lyopreserved (below) amniotic tissue at 5× and 10× magnification. Green are viable cells, and red are non‐viable
FIGURE 2
FIGURE 2
The viability assessment distribution was equivalent between cryo‐ and lyopreserved amniotic membrane samples in each assessment category
FIGURE 3
FIGURE 3
A, Graph of wound size of healers compared with non‐healers at each visit. There was no difference between the slope of healers (−0.13) and slope of non‐healers (−0.12). B, Graph of percent wound area reduction at each visit
FIGURE 4
FIGURE 4
A, Graph of healers, non‐healers, and non‐healer outliers. Purple line represents the five non‐healing patients who had less than 12% wound area reduction at the end of study. Slope of their trajectory was 0.018. B, Graph of percent wound area reduction of the same three groups
See this image and copyright information in PMC

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