Drs. Rivkah Isseroff and Min Zhao from UCDavis, and their project leader Marco Rolandi and other colleagues are reporting exciting progress on their Defense Advanced Research Projects Agency (DARPA) project. Their collaborative efforts involve actively developing and testing intelligent bandages to cut healing time in half. This innovative approach includes the delivery of ion channel modulators and electric currents to precisely promote wound healing. The team’s overarching objective is closed-loop control and precision temporal-spatial modulation.
As background: Backed by up to $16 million in funding from DARPA, UC Santa Cruz engineers are collaborating seamlessly with doctors and scientists at UC Davis and Tufts University. Together, they embarked on an ambitious journey to pioneer bioelectronic intelligent control of wound regeneration. The project integrates bioelectronic devices, machine learning, and regenerative medicine to achieve precise control over the physiological processes crucial for wound healing. (Read more about it)
Further reading about DARPA’s initiatives in Bioelectronics for Tissue Regeneration
In the realm of innovative research in diabetic foot care, Dr. Alejandro Zulbaran y Rojas and his team led by Dr. Bijan Najafi at Baylor College of Medicine are spearheading a study focused on continuous oxygen diffusion for ischemic diabetic foot patients undergoing minor amputations. While the team aims to conclude the study in 2024, some of the preliminary findings were shared at the International Diabetic Foot Symposium in the Hague last May. This research represents a significant stride in optimizing treatment approaches for diabetic patients undergoing minor amputations, with a focus on enhancing tissue oxygenation and supporting the intricate healing process.
Dr. Rojas engaged in a thought-provoking interview with EO2 Concepts, the sponsor of the study. For a more in-depth understanding of their innovative work, you can listen to the interview here.
Dr. Elliot Botvinick and his collaborator Dr. Ali Mohraz from the University of California, Irvine, are transforming insulin delivery by developing an innovative insulin infusion set incorporating a revolutionary material known as bijel templated material (BTM). This unique sponge-like material aligns with a theory suggesting that material shape and internal curvatures can instruct the immune system to dispatch pro-healing signals to the surrounding tissue. Their experiments in mice have confirmed the validity of this concept. The team has recently concluded a six-pig study with promising results and they are currently actively seeking funding to progress to human trials.
Drs. Frank Ross and Louis Iannuzzi from NYU Langone Health are championing the use of total contact casting in their clinic to mitigate the risk of lower extremity amputation. Termed 'The Carville Approach', they find that this method, considered the 'gold standard' for treating Diabetic Foot Ulcers (DFUs) is underutilized in the US. Their data shows a 85% healing rate for DFUs. Last fall, Drs. Jason Zhang and Frank Ross presented this data at the Eastern Vascular Society's national meeting. They will present these findings this March at the Society for Clinical Vascular Surgery (lecture M51 at SCVS 2024).
Dr. Adam L. Isaac from the Foot & Ankle Specialists of the Mid-Atlantic is exploring innovative treatments like ProgenaMatrix, Mirragen, and Debritom+ in post-market studies for chronic DFUs. He is steering a phase 2 study, unraveling the potential of a mesenchymal stem cell patch to transform the landscape of chronic DFU therapy.
Dr. Joseph Larsen of OpTUM Podiatry focuses his research on the continuous diffusion of oxygen as a dressing in elective bunion surgery to decrease the reliance on opioids. He is currently working on a paper detailing this research. He recently spoke at the NYSPMA state conference in NYC where he discussed the utilization of 'Advanced Biologics for Limb salvage'.
Dr. Alexander Fanaroff and his team from Penn Medicine have created a database of over one million Medicare patients with critical limb ischemia (CLTI) with longitudinal (inpatient and outpatient) follow-up. The team described the cohort in a publication in JSCAI and had a podium presentation at SCAI Scientific Sessions.
Ongoing projects using this rich database are looking at the association between the time from the diagnosis of CLTI to revascularization and clinical outcomes. Additionally, the team is looking at the receipt of vascular specialty care in the year prior to a major lower extremity amputation, examining the factors of race, rurality, and socioeconomic status.
After earning our Peter Sheehan Young Innovator Award in Tissue Regeneration and Limb Preservation in 2022 (listen to her presentation here), Dr. Adriana C. Panayi now at BG Klinik Ludwigshafen, University of Heidelberg has established a state-of-the-art lab dedicated to chronic wound healing. Additionally, she has become a member of the Board of the European Tissue Repair Society, and in Spring 2024, she is scheduled to present at the Wound Healing Society Congress.
An update on titles and awards: Dr. Panayi was honored with the Paul Ehrlich Rising Star in Wound Healing Award by the Wound Healing Foundation.
Dr. Ram Kinker Mishra now at Biosensics’ earlier work titled 'The application of digital frailty screening to triage nonhealing and complex wounds', earned him our Peter Sheehan Young Innovator Award in Tissue Regeneration and Limb Preservation in 2022 (listen to his presentation here). This work has been published in the Journal of Diabetes Science and Technology.
In this study, Dr. Mishra and his team showcased how digital biomarkers of frailty, assessed in a quick 20-second test, could serve as a practical tool for prioritizing patients with nonhealing diabetic foot ulcers (DFU).
The identification of patients exhibiting signs of exhaustion frailty phenotype may indicate a heightened risk of presenting with more severe wounds. These findings can promote healthcare equity, alleviate scheduling delays, and reduce the risk of lower extremity amputations with underserved populations.
Dr. Sangeetha Matadhil-Vadakke from Mount Sinai School of Medicine received the Peter Sheehan Young Innovator Award in 2018 (see details of her presentation here) and is currently immersed in research focused on human placental-derived CDX2 cells and their pivotal role in cardiovascular regeneration.
This research has progressed to the translational stage, involving the utilization of approximately 106 human placental samples for their cell culture-based experiments and other related studies. In the upcoming phases, Dr. Madathil-Vadakke plans to conduct cell transplantation experiments in humanized small animal models to delve into the intricacies of cardiac repair, followed by investigations in larger animal models.
An update on titles and awards: Dr. Vadakke-Madathil and her team were featured in the Smithsonian magazine in 2021, and in 2022, they received an i3 Genesis award from Mount Sinai Innovation Partners.
In a groundbreaking study featured in Science Translational Medicine, the Wake Forest Institute for Regenerative Medicine in the USA (WFIRM) has achieved a significant leap forward in skin regeneration, holding promise for comprehensive wound healing, particularly for burn victims and individuals with skin disorders. WFIRM's revolutionary bioprinting technology successfully created full-thickness human skin, including the epidermis, dermis, and hypodermis. In pre-clinical trials, the transplanted bioprinted skin exhibited blood vessel formation, normal tissue patterns, enhanced wound closure, reduced skin contraction, and minimized scarring.
The National University of Singapore (NUS) has developed an innovative magnetic wound-healing gel that accelerates diabetic wound healing 3 times faster than SOC. Applied through a bandage and activated by a wireless magnetic device, the gel, containing skin cells and magnetic particles, improves overall wound health and lowers risks of recurrence.
Researchers at the Ulsan National Institute for Science and Technology in South Korea (UNIST) have harnessed the power of our own blood to revolutionize wound healing. Using a cutting-edge microfluidic system, they have been able to transform autologous blood into implantable vascularized engineered thrombi (IVETs), leading to remarkable scarless recovery in rodent wounds.
Researchers at the Royal Melbourne Institute of Technology (RMIT) and the University of South Australia have developed a nano-thin material using black phosphorus, that is effective against drug-resistant bacteria, including superbugs. Pre-clinical trials have demonstrated over 99% bacterial cell destruction, with 80% wound closure in 7 days.
+++ CLINICAL TRIALS
FDA 510(k) CLEARANCES
--- Maxiocel Chitosan Wound Dressing by Advamedica Inc.
FDA cleared August 2023
Indication for use: The Maxiocel Chitosan Wound Dressing is indicated for the management of moderately to heavily exuding chronic and acute wounds and to provide a barrier against bacterial penetration.
--- 091 Balloon Guide Catheter by EOSolutions, Corp.
FDA cleared October 2023
Indication for use: The 091 Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of intravascular catheters into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for Retrieval devices.
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