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New Study Finds AmnioBand® Membrane Effectively Heals Venous Leg Ulcers in Less Time
Results from multicenter study suggest MTF Biologics allograft is the most cost-effective advanced treatment for chronic venous leg ulcers available
Edison, NJ (November 29, 2022) — A recent study in Plastic and Reconstructive Surgery, the Journal of the American Society of Plastic Surgeons, reports that AmnioBand® Membrane, an aseptically processed, dehydrated human amnion/chorion allograft (dHACA) developed by MTF Biologics, offers greater wound closure for those with chronic venous leg ulcers than standard of care alone. In fact, AmnioBand was shown to achieve full wound closure in 75 percent of these difficult to treat wounds after just 12 weeks of treatment. These results indicate that AmnioBand is one of the most cost-effective advanced treatment options for venous leg ulcers available today.
“This study showed that AmnioBand achieved full wound closure in 75 percent of patients at 12 weeks even when applied biweekly,” said Thomas E. Serena, MD, FACS, FACHM, MAPWCA, founder and medical director of the SerenaGroup® and principal investigator of the study. “This data is exciting as it highlights the advantages of using aseptically processed dHACA to enable bi-weekly treatments and fewer graft applications without compromising patient outcomes. This is an important consideration in a value-based health care delivery model”.
Venous leg ulcers are open wounds that often occur because of a lack of blood pressure regulation in patients’ legs. Ulcers typically form around patients’ ankles but can form elsewhere on the leg. It is estimated that 1 to 3 percent of the elderly population in the United States will be impacted by a venous leg ulcer, and they are most common in women over the age of 50. These wounds can be very difficult to heal, making them costly and complex to treat. In the United States, venous leg ulcers represent an annual economic burden of $14.9 billion to Medicare and commercial payers.
The published study was a prospective, multicenter, randomized controlled clinical trial designed to evaluate percentage wound closure and percentage of wound area reduction after a 12-week period. As part of the study, which was sponsored by MTF Biologics, researchers evaluated two application regimens of AmnioBand plus standard of care compared to standard of care alone for patients with chronic venous leg ulcers across eight wound care centers in the United States. Patients were enrolled into one of three groups: weekly standard of care treatments, weekly applications of AmnioBand plus standard of care, or biweekly applications of AmnioBand plus standard of care.
When applied either weekly or biweekly to patients with chronic venous leg ulcers, AmnioBand achieved full wound closure in 75 percent of patients over the 12-week period. The study also found the AmnioBand groups had a significantly higher median percentage wound area reduction of 100% vs 75% wound area reduction in the standard of care alone group at the 12 week timepoint.
“Venous leg ulcers are notoriously hard to treat,” said Marc Long, PhD, executive vice president of R&D and clinical and medical affairs at MTF Biologics. “This is evident by the fact that there are so few studies showing such positive clinical outcomes for patients with these wounds. We are pleased to see the results achieved by AmnioBand in those with venous leg ulcers and look forward to continuing to evaluate its use for these patients.”
Read “A Multicenter Randomized Controlled Clinical Trial Evaluating Two Application Regimens of Dehydrated Human Amniotic Membrane and Standard of Care vs Standard of Care Alone in the Treatment of Venous Leg Ulcers” here: https://journals.lww.com/plasreconsurg/Fulltext/2022/11000/A_Multicenter,_Randomized,_Controlled,_Clinical.39.aspx. Learn more about AmnioBand® Membrane at https://www.mtfbiologics.org/our-products/detail/amnioband-membrane.
About MTF Biologics
MTF Biologics is a global nonprofit organization that saves and heals lives by honoring donated gifts, serving patients and advancing science. It provides exceptional service, resources, and expertise to donors and their loved ones who give the gift of donation; patients who depend on tissue and organ transplants; healthcare providers who care for donors and recipients; and, clinicians and scientists advancing medicine through transplantation science and research.
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New Study Finds AmnioBand® Membrane Effectively Heals Venous Leg Ulcers in Less Time
Results from multicenter study suggest MTF Biologics allograft is the most cost-effective advanced treatment for chronic venous leg ulcers available
Edison, NJ (November 29, 2022) — A recent study in Plastic and Reconstructive Surgery, the Journal of the American Society of Plastic Surgeons, reports that AmnioBand® Membrane, an aseptically processed, dehydrated human amnion/chorion allograft (dHACA) developed by MTF Biologics, offers greater wound closure for those with chronic venous leg ulcers than standard of care alone. In fact, AmnioBand was shown to achieve full wound closure in 75 percent of these difficult to treat wounds after just 12 weeks of treatment. These results indicate that AmnioBand is one of the most cost-effective advanced treatment options for venous leg ulcers available today.
“This study showed that AmnioBand achieved full wound closure in 75 percent of patients at 12 weeks even when applied biweekly,” said Thomas E. Serena, MD, FACS, FACHM, MAPWCA, founder and medical director of the SerenaGroup® and principal investigator of the study. “This data is exciting as it highlights the advantages of using aseptically processed dHACA to enable bi-weekly treatments and fewer graft applications without compromising patient outcomes. This is an important consideration in a value-based health care delivery model”.
Venous leg ulcers are open wounds that often occur because of a lack of blood pressure regulation in patients’ legs. Ulcers typically form around patients’ ankles but can form elsewhere on the leg. It is estimated that 1 to 3 percent of the elderly population in the United States will be impacted by a venous leg ulcer, and they are most common in women over the age of 50. These wounds can be very difficult to heal, making them costly and complex to treat. In the United States, venous leg ulcers represent an annual economic burden of $14.9 billion to Medicare and commercial payers.
The published study was a prospective, multicenter, randomized controlled clinical trial designed to evaluate percentage wound closure and percentage of wound area reduction after a 12-week period. As part of the study, which was sponsored by MTF Biologics, researchers evaluated two application regimens of AmnioBand plus standard of care compared to standard of care alone for patients with chronic venous leg ulcers across eight wound care centers in the United States. Patients were enrolled into one of three groups: weekly standard of care treatments, weekly applications of AmnioBand plus standard of care, or biweekly applications of AmnioBand plus standard of care.
When applied either weekly or biweekly to patients with chronic venous leg ulcers, AmnioBand achieved full wound closure in 75 percent of patients over the 12-week period. The study also found the AmnioBand groups had a significantly higher median percentage wound area reduction of 100% vs 75% wound area reduction in the standard of care alone group at the 12 week timepoint.
“Venous leg ulcers are notoriously hard to treat,” said Marc Long, PhD, executive vice president of R&D and clinical and medical affairs at MTF Biologics. “This is evident by the fact that there are so few studies showing such positive clinical outcomes for patients with these wounds. We are pleased to see the results achieved by AmnioBand in those with venous leg ulcers and look forward to continuing to evaluate its use for these patients.”
Read “A Multicenter Randomized Controlled Clinical Trial Evaluating Two Application Regimens of Dehydrated Human Amniotic Membrane and Standard of Care vs Standard of Care Alone in the Treatment of Venous Leg Ulcers” here: https://journals.lww.com/plasreconsurg/Fulltext/2022/11000/A_Multicenter,_Randomized,_Controlled,_Clinical.39.aspx. Learn more about AmnioBand® Membrane at https://www.mtfbiologics.org/our-products/detail/amnioband-membrane.
About MTF Biologics
MTF Biologics is a global nonprofit organization that saves and heals lives by honoring donated gifts, serving patients and advancing science. It provides exceptional service, resources, and expertise to donors and their loved ones who give the gift of donation; patients who depend on tissue and organ transplants; healthcare providers who care for donors and recipients; and, clinicians and scientists advancing medicine through transplantation science and research.
MTF Biologics is a registered trademark of the Musculoskeletal Transplant Foundation.