Future applications for the early, preventative use of amniotic membrane allografts in addition to the current standard of care for DFUs present a novel opportunity to reduce long-term morbidity and amputation risk in diabetic patients.
PENSACOLA, Fla., Aug. 8, 2022 /PRNewswire/ — A new MDPI study, co-authored by Regenative Labs signifies a huge win for patients suffering from diabetic foot ulcers (DFUs). DFUs are debilitating for an individual. They are painful, long lasting, and, even with proper care, can lead to amputation. The current standard of care for DFUs is debridement, the medical removal of dead, damaged, or infected tissue to improve the healing potential of the remaining healthy tissue. The increased healing time and augmented risk of amputation associated with the current standard of care only solidifies the need for new DFU treatment alternatives. Regenerative medicine is such an alternative.
With approximately 37.3 million diabetic adults in the United States, physicians are faced with an epidemic. Given the projected increase of 1.4 million new diagnoses of diabetes mellitus each year, advancing knowledge and care for the disease and its related conditions is especially relevant.
Regenative Labs’ AmnioText™, a dehydrated amniotic membrane allograft, was used to close a grade 5 wound according to the Curative Health Services (CHS wound grade scale), described as full thickness and subcutaneous tissues, exposed tendons, ligaments, and/or joints, plus necrotic tissue in the wound, in 7 weeks. Grade 5 wounds have a 91.5% rate of not healing at all. This unsettling outcome emphasizes the efficacy and importance of amniotic membrane allografts in revolutionizing the standard of care for DFUs.
The inability to heal DFUs presents a severe danger to patients as anywhere from 5 to 24% of untreated DFUs can lead to limb amputation within 6–18 months. These infections can lead to long-term impairment and possible lower-limb amputation without timely and correct management.
“Regenative Labs and our products are focused on ameliorating this problem with our outcomes-based approach. We provide the highest quality amniotic membrane allograft to allow doctors to provide predictable outcomes for their patients,” shared Regenative Labs CEO, Tyler Barrett.
Amniotic membrane allografts, such as those provided by Regenative Labs, have proven to augment the body’s ability to regenerate the structural tissue defects associated with DFUs; they are also comparable in cost to the standard of care, which averages about USD 17,245. Not only is the current standard of care for DFUs less effective, but it is also high in cost and typically relies on inpatient expenditures.
Medicare now recognizes the medical necessity of amniotic membrane allografts in the treatment of both DFUs and venous stasis ulcers. Consequently, many patients rely on Medicare to assist with the costs associated with DFU treatment. This presents the opportunity for human amniotic membrane allografts to be utilized in rural and underserved communities where DFU treatment is typically delayed due to high costs and a lack of supplies associated with traditional treatment. This could exponentially decrease the risk of amputations in diabetic patients in these rural and underserved communities.