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. 2016 Dec;15(4):360-365.
doi: 10.1177/1534734616671639. Epub 2016 Nov 16.

Wound Closure in Smoking Peripheral Arterial Disease Patients With Treatment-Refractory Ulcerations: A 12-Month Follow-up Case Series

Affiliations

Wound Closure in Smoking Peripheral Arterial Disease Patients With Treatment-Refractory Ulcerations: A 12-Month Follow-up Case Series

Jonathan Smedley et al. Int J Low Extrem Wounds. 2016 Dec.

Abstract

Despite ongoing smoking cessation efforts and optimized perfusion, failed wound closure in the presence of peripheral arterial disease (PAD) and diabetes are common. A clinical effectiveness review was conducted in actively smoking diabetic patients diagnosed with PAD, treated with serial applications of a viable intact cryopreserved human placental membrane (vCPM) (Grafix, Osiris Therapeutics Inc, Columbia, MD) for recalcitrant lower extremity ulcerations (n = 6). More than half of the patients were not candidates for revascularization. Baseline vascular status in 5 of 6 lower-extremity wounds remained unchanged throughout the entire course of vCPM treatment. Daily cigarette consumption averaged 18 cigarettes per patient. Mean wound duration and mean surface area was 53 weeks and 4.6 cm2, respectively. Mean number of vCPM applications and time to closure was 7.0 grafts in 7.8 weeks. There were no wound-related infections or amputations and no vCPM-related adverse events. All 6 wounds remained closed at the 12-month follow-up visit. In conclusion, vCPM demonstrated clinically effective outcomes in 6 previously nonhealing ulcerations despite ongoing smoking habits in the presence of PAD and diabetes.

Keywords: cigarette smoking; peripheral arterial disease; treatment refractory; viable cryopreserved placental membrane.

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Conflict of interest statement

Declaration of Conflicting Interests: The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article. Jonathan Smedley is an employee of Precision Podiatry. He is a member of the speakers’ bureau at and consultant to Osiris Therapeutics, Inc. Georgina M. Michael and Yeabsera G. Tamire are employees of Osiris Therapeutics, Inc.

Figures

Figure 1.
Figure 1.
Study wound 3. (A) Baseline: 9.7 cm2 wound of the right anterolateral tibia with a duration of 256 days prior to application of vCPM. (B) Day 49: 50.5% PAR after 5 applications (C) Day 56: 71.5% PAR after 6 applications. (D) Day 77: Final wound closure following 9 vCPM applications. PAR, percentage area reduction; vCPM, viable intact cryopreserved human placental membrane.
Figure 2.
Figure 2.
Progressive reductions in wound surface area with serial viable intact cryopreserved human placental membrane (vCPM) applications.

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