Wound Closure in Smoking Peripheral Arterial Disease Patients With Treatment-Refractory Ulcerations

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.

A multicenter, randomized, single‐blind trial comparing the efficacy of viable cryopreserved placental membrane to human fibroblast‐derived dermal substitute for the treatment of chronic diabetic foot ulcers

“…The benefits of placental membrane, specifically amnion, have been reported in the literature for more than 100 years . vCPM retains the extracellular matrix, growth factors, and viable cells native to the placental membrane and can be used in the treatment of acute and chronic wounds of different etiologies and locations . In contrast, hFDS (Dermagraft ® ), a product that has been on the U.S. market since 2001, is a bioengineered skin substitute .…”

Management of a chronic radiation necrosis wound with lyopreserved placental membrane containing viable cells

“…20 Also in 2016, a retrospective review of five actively smoking diabetics with six nonhealing ulcers and peripheral arterial disease (PAD) who received serial applications of vCPM reported positive outcomes, as all patients achieved complete wound closure. 21 Further, Anselmo et al 22 showed positive clinical outcomes with vCPM in the treatment of three chronic wounds that had previously failed standard wound care treatments. These patients also had significant comorbidities including chronic heart failure, diabetes, peripheral vascular disease, and venous insufficiency.…”

“…One proprietary cryopreservation method developed by Osiris Therapeutics results in high cell viability within the preserved placental membrane and is a commercially available cryopreserved placental membrane product containing viable cells . Cryopreserved placental membrane (vCPM) retains the components of fresh placental membrane, and its clinical effectiveness has been demonstrated in various trials with hard‐to‐treat wounds using vCPM plus standard of care …”

“…This patient population had significant comorbidities such as heart disease, kidney disease, and previous partial foot amputations . Also in 2016, a retrospective review of five actively smoking diabetics with six nonhealing ulcers and peripheral arterial disease (PAD) who received serial applications of vCPM reported positive outcomes, as all patients achieved complete wound closure . Further, Anselmo et al showed positive clinical outcomes with vCPM in the treatment of three chronic wounds that had previously failed standard wound care treatments.…”

“…15,16 Cryopreserved placental membrane (vCPM) retains the components of fresh placental membrane, and its clinical effectiveness has been demonstrated in various trials with hard-to-treat wounds using vCPM plus standard of care. [20][21][22][23] In 2016, Frykberg et al demonstrated positive clinical outcomes in the treatment of complex diabetic foot ulcers (DFU) with vCPM. This patient population had significant comorbidities such as heart disease, kidney disease, and previous partial foot amputations.…”