Placental Membrane Provides Improved Healing Efficacy and Lower Cost Versus a Tissue-Engineered Human Skin in the Treatment of Diabetic Foot Ulcerations

Glat, Paul M.; Orgill, Dennis P.; Galiano, Robert D.; Armstrong, David G.; Serena, Thomas E; DiDomenico, Lawrence A.; Kaufman, Jarrod P.; Carter, Marissa J.; Jacobs, Alan M.; Zelen, Charles M.

doi:10.1097/gox.0000000000002371

Cited by 24 publications

(31 citation statements)

References 27 publications

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“…After exclusion of 113 duplicates, the remaining records were screened and of which, 313 were deleted according to the inclusion and exclusion criteria. Then, detailed evaluation of full texts resulted in the removal of 34 articles for the following reasons: were reviews (n = 23); were not RCTs (n = 7); was a duplicate study (n = 1) 26 ; ST was not used as control treatment (n = 3) 27‐29 . Finally, nine studies were eligible for this meta‐analysis 18,30‐37 .…”

Section: Resultsmentioning

confidence: 99%

“…It has low immunogenicity and beneficial reepithelialization effects, with anti‐inflammatory, antimicrobial, antifibrotic, and other properties, which contributes to HACM as an ideal dressing with superiority over other biological and synthetic dressings 20 . In recent years, HACM therapy has shown remarkable therapeutic effects in several clinical trials, even compared with other dressings 18,27,28,30‐37 . Given the advantages of using HACM products and the demand for clinical conduct supported by evidence‐based practice, several systematic reviews, and meta‐analyses have been performed.…”

Section: Discussionmentioning

confidence: 99%

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Effectiveness and safety of human amnion/chorion membrane therapy for diabetic foot ulcers: An updated meta‐analysis of randomized clinical trials

Huang

Chen

Wang

et al. 2020

Wound Repair Regeneration

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Human amnion/chorion membrane therapy has shown advantages in the management of diabetic foot ulcers and its effectiveness has been evaluated in the systematic reviews and meta‐analyses. However, the number of patients included in the previous literatures was small and the safety profile of human amnion/chorion membrane therapy was not concerned. Therefore, we conducted an updated meta‐analysis to better understand the effectiveness and safety of human amnion/chorion membrane therapy for diabetic foot ulcers. The PubMed, Embase, Cochrane Library, and http://clinicaltrial.gov databases were searched for any randomized clinical trials comparing human amnion/chorion membrane therapy and standard therapy in the treatment of diabetic foot ulcers. Ulcer healing rate was considered as the primary outcome and the secondary outcomes mainly included mean time to ulcer healing and adverse events. Nine RCTs with 541 patients were included. Compared with merely standard therapy, human amnion/chorion membrane therapy plus standard therapy improved the ulcer healing rates at 6 weeks (RR = 3.50, 95% CI: 2.35‐5.21), 12 weeks (RR = 2.09, 95% CI: 1.53‐2.85) and 16 weeks (RR = 1.70, 95% CI: 1.25‐2.30), and also shortened the healing time (MD = −4.58, 95% CI: −5.70 to −3.46). Meanwhile, no significant difference was observed in the number of patients with adverse events (RR = 0.56, 95% CI: 0.31‐1.03) between two groups. This meta‐analysis suggests that human amnion/chorion membrane therapy as an adjuvant treatment could promote the healing of diabetic foot ulcers and has a safety profile. More evidence from large high‐quality randomized clinical trials with long follow‐up duration are in urgent need to further confirm our findings.

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Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Effectiveness and safety of human amnion/chorion membrane therapy for diabetic foot ulcers: An updated meta‐analysis of randomized clinical trials

Huang

Chen

Wang

et al. 2020

Wound Repair Regeneration

View full text Add to dashboard Cite

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“…71 Moreover, some RCTs showed higher probability of wound healing for patients receiving human amniotic membrane products when compared with bioengineered skin substitutes. 72,73 However, 2 retrospective analyses of real world data did not confirm these findings and instead showed superiority of bioengineered skin substitutes. 74,75 This discrepancy could be attributed to several factors like the design of the studies, the differences between real-world patients and study population, and the fact that most RCTs are industry-funded.…”

Section: Adjunct Therapiesmentioning

confidence: 99%

Nonpharmacological Management of Diabetic Foot Ulcers: An Update

Eleftheriadou

Samakidou

Tentolouris

et al. 2020

The International Journal of Lower Extremity Wounds

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Diabetic foot ulcers (DFUs) are a common and serious complication of diabetes mellitus that is associated with increased morbidity and mortality, as well as substantial economic burden for the health care system. The standard of care for DFUs includes pressure off-loading, sharp debridement, and wound moisture balance, along with infection control and management of peripheral arterial disease. A variety of advanced modalities that target distinct pathophysiological aspects of impaired wound healing in diabetes are being studied as possible adjunct therapies for difficult to heal ulcers. These modalities include growth factors, stem cells, cultured fibroblasts and keratinocytes, bioengineered skin substitutes, acellular bioproducts, human amniotic membranes, oxygen therapy, negative pressure wound therapy, and energy therapies. Additionally, the use of advanced biomaterials and gene delivery systems is being investigated as a method of effective delivery of substances to the wound bed. In the present narrative review, we outline the latest advances in the nonpharmacological management of DFUs and summarize the efficacy of various standard and advanced treatment modalities.

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“…El costo en el grupo membrana placentaria fue significativamente menor que el del grupo TESS ($2.200 frente a $7.900). Por tanto la membrana placentaria cura las UDF significativamente más rápido y con un costo significativamente menor que TESS (6).…”

Section: Estimado Editorunclassified

Membrana placentaria en el tratamiento de las úlceras del pie diabético

Pizarro

2020

Enferm. investig.

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La úlcera del pie diabético (UDF) es una de las principales causas de morbilidad y pérdida de calidad de vida en pacientes diabéticos. En los estudios de los últimos años se ha sugerido el uso de membrana placentaria en dichas úlceras. Las membranas amnióticas placentarias están compuestas de células, matriz extracelular y un complejo de citocinas reguladoras que promueven la proliferación y modulación celular involucradas en la cicatrización de úlceras (1). En el estudio de Oesman I et al. (2020), se reclutaron tres pacientes con UDF., fueron tratados con membrana placentaria tratada con rayos gamma y seguidos durante un mes, se aplicaron dos capas de apósito de membrana placentaria semanalmente después de la limpieza y desbridamiento durante 3 semanas. Al final de la tercera semana, la úlcera se curó. Este estudio demostró que la membrana placentaria favorece la curación de las úlceras que no cicatrizan con el tratamiento convencional (2).

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Placental Membrane Provides Improved Healing Efficacy and Lower Cost Versus a Tissue-Engineered Human Skin in the Treatment of Diabetic Foot Ulcerations

Abstract: Supplemental Digital Content is available in the text.

Cited by 24 publications

References 27 publications

Effectiveness and safety of human amnion/chorion membrane therapy for diabetic foot ulcers: An updated meta‐analysis of randomized clinical trials

Effectiveness and safety of human amnion/chorion membrane therapy for diabetic foot ulcers: An updated meta‐analysis of randomized clinical trials

Nonpharmacological Management of Diabetic Foot Ulcers: An Update

Membrana placentaria en el tratamiento de las úlceras del pie diabético

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