Amputation, Traumatic

Peripheral artery disease contributes to about 400 amputations performed each day in the U.S. Peripheral artery disease (PAD) is one of the leading causes of non-trauma-related amputations, but 70% of Americans have never heard of this disease, according to a new survey. To help change this, four leading heart and vascular societies, in collaboration with industry sponsors including Philips, have united to form the PAD Pulse Alliance. The alliance aims to increase awareness about the condition and encourage patients to discuss their symptoms with their doctors. PAD is a common condition where a buildup of fatty deposits in the arteries restricts blood supply to leg muscles, which can cause leg pain, and is a form of cardiovascular disease. The PAD Pulse Alliance said in a press release that this contributes to about 400 amputations performed each day in the U.S. To boost awareness, the campaign has launched a new website called “Get a Pulse on PAD” that sets out resources for patients to use and asks visitors to “be your own PAD champion.” Linked to the campaign is also a new survey which has shown that up to 70% of Americans do not know about the disease. The survey, conducted among 1,000 Americans in the general population along with two additional groups comprising 500 individuals from the Black community and 500 from the Hispanic community, revealed that nearly 75% of Black and Hispanic adults surveyed either have or know someone with diabetes, high blood pressure or is a smoker. Surprisingly, only 30% believe they could be at risk. “This is in stark contrast to real-world impact,” the alliance said in the release, as Black people are twice as likely to suffer from PAD and up to four times more likely to undergo an amputation compared to white people. Hispanics present with more progressive PAD leading to worse outcomes including greater risk of amputation. Nearly all the survey respondents (91%) would dismiss pain as just part of getting older, but pain in your leg when walking that goes away with rest is one of the first symptoms of PAD. Meanwhile, just over half (53%) of respondents would wait more than a week with ongoing leg pain before calling their doctor. “Screening for PAD is easy, quick, and non-invasive. Yet, this survey confirmed that critical patient-provider conversations addressing common symptoms aren't happening,” said Society of Interventional Radiology President Alda L. Tam, M.D., an interventional radiologist and professor in the Department of Interventional Radiology at the University of Texas MD Anderson Cancer Center in Houston, in the release. “If we can educate more people on the risk factors and early warning signs associated with PAD, it's our hope we can foster dialogue earlier between providers and patients to kick off screening and treatment, ultimately preventing amputations and saving lives.” The alliance is sponsored by Gore, Shockwave Medical and Philips, the last two of which market medical tech for cardiovascular disease and PAD.

Phase I/II trial assessing the safety and efficacy of RECCE® 327 (R327), a broad-spectrum anti-infective as a topical treatment, met all primary endpoints R327 was well-tolerated in all patients, resolving mild skin and soft tissue diabetic foot infections (DFI), including multidrug-resistant Gram-positive and Gram-negative pathogens Jan. 23, 2024 -- Recce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q), (the Company), the Company developing a new class of synthetic anti-infectives, today announced positive results from a Phase I/II trial assessing the safety and efficacy of its lead synthetic anti-infective candidate, RECCE® 327 (R327), in patients with diabetic foot infections (DFI). “We are pleased that the Phase I/II clinical trial has met all primary endpoints and produced efficacy data to support R327 as a topical agent,” said James Graham, Chief Executive Officer of Recce Pharmaceuticals. “We look forward to expanding the study by accessing a global patient population and further enhancing our portfolio of human efficacy data.” The Phase I/II trial is an interventional study assessing the safety and efficacy of R327 as a topical broad-spectrum anti-infective treatment for patients with mild skin and soft tissue DFIs. Patients were treated either daily or every second day for 14 days. The study achieved its primary endpoint of resolving/curing bacterial infections in DFIs. Following this success, Recce will look to expand clinical sites domestically and internationally to access a greater patient population. Summary of Treated Patients Patient 1 (Daily) – (Methicillin-Resistant Staphylococcus aureus infection) * A 32-year-old male with a four-year history of type 2 diabetes mellitus, coupled with various cardiovascular risk factors such as hypertension, obesity, and dyslipidaemia, abnormally elevated cholesterol in the blood. The 235kg patient was recruited with a significant neuropathic wound, an infection that affects one or more nerves, on the left side of his left foot. The patient was on systemic therapy and was required to stop treatment to meet the trial protocol of R327, requiring solely topical application. On day 15 (midpoint), post-R327 treatment, the initial redness of the wound and swelling of the foot had minimized and reduced in size. Due to patient comorbidities and the complexity of the wound, the patient was returned to systemic therapy, resulting in disqualification from the trial. On Day 28, the infection was resolved, and all therapy ceased. Patient 2 (Second Daily) – Infection Resolved/Cured (Staphylococcus aureus, mixed skin flora, and Coliforms) A 55-year-old male with a 23-year history of type 2 diabetes mellitus and an active neuropathic DFI wound on his right big toe, with recurrent infections unresponsive to several antibiotics. After three doses of R327 treatment (midpoint – day 7), the infection was significantly reduced, with the wound drying and rapidly improving. By the endpoint (day 14) of the patient’s treatment, the infection was resolved/cured, and no recurrence of infection was identified. R327 was well-tolerated and effective throughout the patient’s treatment therapy. Patient 3 (Second Daily) – Infection Resolved/Cured (Staphylococcus aureus, mixed skin flora, and mixed coliforms) A 52-year-old male with a 16-year history of type 2 diabetes mellitus and a DFI wound on the left side of his left foot. After three doses of R327 (midpoint – day 7), the infection was significantly reduced and shown to be rapidly clearing. At the endpoint (day 14) of the R327 treatment, the infection had been resolved. No follow-ups were required, as R327 was well-tolerated and effective throughout the patient’s treatment. Patient 4 (Daily) – Infection Resolved/Cured in Half the Treatment Time (mixed skin flora) A 70-year-old male with type 2 diabetes mellitus and a DFI wound on the left side of his left foot. The patient was observed at the midpoint (day 7) of the R327 treatment, with the infection resolved/cured in half the time. No follow-ups were required, as R327 was well-tolerated and effective throughout the patient’s treatment. Patient 5 (Daily) – Infection Resolved/Cured (mixed skin flora and Coliforms) A 64-year-old male with type 2 diabetes mellitus and a DFI wound on his right foot. At the midpoint (day 7) of R327 treatment, the infection was significantly reduced and shown to be improving. At the endpoint (day 14) of the R327 treatment, the infection had been resolved. R327 was well-tolerated and effective throughout the patient’s treatment. Diabetes is the leading cause of non-traumatic lower extremity amputations in the United States (U.S.), with 14-24% of patients with diabetes (who develop a foot ulcer) requiring amputation. Furthermore, foot ulceration leads to 85% of diabetes-related amputations. Treating diabetic foot diseases in the U.S. costs $9-13 billion annually.1 A worldwide meta-analysis reported diverse bacteria from DFI, and the organism most commonly identified was Staphylococcus aureus, with a pooled prevalence estimate of 18.0%.2 Recce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q) is developing a New Class of Synthetic Anti-Infectives designed to address the urgent global health problems of antibiotic-resistant superbugs and emerging viral pathogens. Recce’s anti-infective pipeline includes three patented, broad-spectrum, synthetic polymer anti-infectives: RECCE® 327 as an intravenous and topical therapy that is being developed for the treatment of serious and potentially life-threatening infections due to Gram-positive and Gram-negative bacteria including their superbug forms; RECCE® 435 as an orally administered therapy for bacterial infections; and RECCE® 529 for viral infections. Through their multi-layered mechanisms of action, Recce’s anti-infectives have the potential to overcome the hypercellular mutation of bacteria and viruses – the challenge of all existing antibiotics to date. The FDA has awarded RECCE® 327 Qualified Infectious Disease Product designation under the Generating Antibiotic Initiatives Now (GAIN) Act – labelling it for Fast Track Designation, plus 10 years of market exclusivity post approval. Further to this designation, RECCE® 327 has been included on The Pew Charitable Trusts Global New Antibiotics in Development Pipeline as the world’s only synthetic polymer and sepsis drug candidate in development. RECCE® 327 is not yet market approved for use in humans with further clinical testing required to fully evaluate safety and efficacy. Recce wholly owns its automated manufacturing, which is supporting present clinical trials. Recce’s anti-infective pipeline seeks to exploit the unique capabilities of its technologies targeting synergistic, unmet medical needs. 1 Zhang P. et al. – “Global epidemiology of diabetic foot ulceration: A systematic review and meta-analysis” (dagger) - Ann. Med. 2017;49:106–116. 2 https://www.nature.com/articles/s41598-023-41882-z The content above comes from the network. if any infringement, please contact us to modify.

First-of-its-kind cell therapy promotes wound healing, improves overall wound health and lowers risks of recurrence SINGAPORE, Oct. 19, 2023 /PRNewswire/ -- Diabetic patients, whose natural wound-healing capabilities are compromised, often develop chronic wounds that are slow to heal. Such non-healing wounds could cause serious infections resulting in painful outcomes such as limb amputation. To address this global healthcare challenge, a team of researchers from the National University of Singapore (NUS) engineered an innovative magnetic wound-healing gel that promises to accelerate the healing of diabetic wounds, reduce the rates of recurrence, and in turn, lower the incidents of limb amputations. Each treatment involves the application of a bandage pre-loaded with a hydrogel containing skin cells for healing and magnetic particles. To maximise therapeutic results, a wireless external magnetic device is used to activate skin cells and accelerate the wound healing process. The ideal duration of magnetic stimulation is about one to two hours. Lab tests showed the treatment coupled with magnetic stimulation healed diabetic wounds about three times faster than current conventional approaches. Furthermore, while the research has focussed on healing diabetic foot ulcers, the technology has potential for treating a wide range of complex wounds such as burns. "Conventional dressings do not play an active role in healing wounds," said Assistant Professor Andy Tay, who leads the team comprising researchers from the Department of Biomedical Engineering at NUS College of Design and Engineering as well as the NUS Institute for Health Innovation & Technology. "They merely prevent the wound from worsening and patients need to be scheduled for dressing change every two or three days. It is a huge cost to our healthcare system and an inconvenience to patients." In contrast, the unique NUS invention takes a comprehensive 'all-in-one' approach to wound healing, accelerating the process on several fronts. "Our technology addresses multiple critical factors associated with diabetic wounds, simultaneously managing elevated glucose levels in the wound area, activating dormant skin cells near the wound, restoring damaged blood vessels, and repairing the disrupted vascular network within the wound," explained Asst Prof Tay. The NUS team described their innovation in a paper published in the scientific journal, Advanced Materials, on 8 September 2023. The research was conducted in collaboration with scientists from the Agency for Science, Technology and Research, Nanyang Technological University, Sun Yat-sen University and Wuhan University of Technology. Chronic diabetic wounds: A major healthcare challenge Currently, more than half a billion people globally are living with diabetes and this number is expected to rise significantly. Chronic diabetic wounds such as foot ulcers (one of the most common and hardest to treat wounds) have therefore become a major global healthcare challenge. Traditional treatments for these wounds are often unsatisfactory, leading to recurring and persistent health issues and – in a high number of cases – limb amputation. Every year, there are around 9.1 to 26.1 million cases of diabetic foot ulcer worldwide, and around 15 to 25 per cent of patients with diabetes will develop a diabetic foot ulcer during their lifetime. Singapore has one of the highest rates of lower limb amputation due to diabetes globally, averaging around four per day. Gentle 'work-out' for skin cells Skin cells experience mechanical forces continuously from normal daily activities. However, patients with wounds are usually advised not to carry out rigorous activities, such as walking, and this could kill the remaining cells essential for healing. "What our team has achieved is to identify a sweet spot by applying gentle mechanical stimulation," said Asst Prof Tay. "The result is that the remaining skin cells get to 'work-out' to heal wounds, but not to the extent that it kills them." The specially designed wound-healing gel is loaded with two types of FDA-approved skin cells – keratinocytes (essential for skin repair) and fibroblast (for formation of connective tissue) – and tiny magnetic particles. When combined with a dynamic magnetic field generated by an external device, the mechanical stimulation of the gel encourages dermal fibroblasts to become more active. Lab tests showed that the increased fibroblast activity generated by the magnetic wound-healing gel increases the cells' growth rate by approximately 240 per cent and more than doubles their production of collagen – a crucial protein for wound healing. It also improves communication with keratinocytes to promote the formation of new blood vessels. "The approach we are taking not only accelerates wound healing but also promotes overall wound health and reduces the chances of recurrence," added Asst Prof Tay. The NUS team worked on the project from 2021 to 2023 to demonstrate the viability of this new approach. A patent has been filed for this innovation. Potential game-changer in wound management While the magnetic wound-healing gel has shown great promise in improving diabetic wound healing, it could also revolutionise the treatment of other complex wound types. "The magneto-responsive hydrogel, combined with wireless magneto-induced dynamic mechanical stimulation, addresses fundamental challenges in wound healing, such as creating a conducive microenvironment and promoting tissue regeneration," said co-first author of the research paper Dr Shou Yufeng, Research Fellow from the Department of Biomedical Engineering at NUS College of Design and Engineering. "These principles and our technology's adaptability, as well as its general ease of use for patients, means that it can be applied to improve wound healing in various situations beyond diabetes, including burns and chronic non-diabetic ulcers." The researchers are conducting more tests to further refine the magnetic wound-healing gel to improve its effectiveness. They are also collaborating with a clinical partner to test the effectiveness of the gel using diabetic human tissues. "This is major step forward in active wound care," said Asst Prof Tay. "Our goal is to provide an effective and convenient wound-healing solution that improves outcomes for millions around the world." "Wound healing, especially in the field of diabetic foot ulcers, has always been a challenging arena. Diabetic foot patients do not heal as well as normal patients and their healing journey is often prolonged," said Assistant Professor Francis Wong Keng Lin, Consultant, Department of Orthopaedic Surgery, Sengkang General Hospital. Asst Prof Wong, who is not involved in the study, added, "Advancements in wound healing technologies will reduce the duration of the patient journey and would allow them to return to their lives as quickly as possible, hence improving productivity and quality of life." Read more at: SOURCE National University of Singapore