Cryopreserved Amniotic Membrane for Foot & Ankle Wounds

Amniotic Membrane for Foot and Ankle Wounds

Abstract

We reviewed the background information and previous clinical studies that considered the use of allogeneic amniotic tissue and fluid (granulized amniotic membrane and amniotic fluid) in the treatment of chronic diabetic foot wounds. This innovation represents a relatively new approach to wound management by delivering a unique allograft of live human cells in a nonimmunogenic structural tissue matrix. Developed to fill soft tissue defects and bone voids and to convey antimicrobial and anti-inflammatory capabilities, granulized amniotic membrane and amniotic fluid does not require fetal death, because its procurement is performed with maternal consent during birth. In the present investigation, 20 chronic wounds (20 patients) that had been treated with standard wound therapy for a mean of 36.6 ± 31.58 weeks and with a mean baseline area of 10.15 ± 19.54 cm2 were followed up during a 12-week observation period or until they healed. A total of 18 of the wounds (90%) healed during the 12-week observation period, and none of the wounds progressed to amputation. From our experience with the patients in the present case series, we believe that granulized amniotic membrane and amniotic fluid represents a useful option for the treatment of chronic diabetic foot wounds.

Source: Journal of Foot & Ankle Surgery

author avatar
Bruce Bertman, CEO of Zizion Group LLC & Networld Online, Inc.
Bruce Bertman, CEO of Zizion Group LLC and Networld Online, Inc., is a distinguished marketing professional with a career spanning work with AT&T, IBM, Inacomp Computer Centers, and numerous charitable organizations. Based in Boca Raton, Florida, he leads Zizion’s global medical device distribution operations and represents the company at international events. As a business innovator and speaker, Bertman launched three companies and guided hundreds of clients to sales success. As CEO of Networld Online, he’s a respected digital marketing leader and visionary who empowers clients and partners to succeed.

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Performance Data

510(k) equivalence study conducted and the following mean results were achieved: