Amputation, Traumatic

Researchers from Singapore have recently introduced a mobile application that teaches diabetes patients about diabetic foot ulcers and self foot care. WHAT IT DOES Developed in consultation with clinicians from Tan Tock Seng Hospital (TTSH) and National Healthcare Group, the app called WellFeet delivers comprehensive patient education through animations in multiple languages, including English, Mandarin, Malay and Tamil. It also serves as a log and diary for patients, gamifying the daily tracking of their medication, physical activity, and diet. This data in turn allows doctors to monitor their progress and customise their exercise goals. Additionally, the app features a chatbot assistant for patients, which also delivers prompts for self-reflection to help them gain insight into their thoughts and feelings, identify patterns or triggers, and eventually take positive action to change their behaviour or mindset. The app was first tested in a research project involving some 800 patients and caregivers across five healthcare institutions in the country which probed their foot care behaviours. Another study also tested the app on 40 pairs of patients and caregivers from TTSH which later revealed positive changes in foot care behaviour and diabetes self-care routines after one month of app usage. The research team is now fine-tuning the app with a plan to potentially integrate AI and human health coaching to provide "more timely and personalised support." It is slated to be released as a free-of-charge app to the public by mid-2024. The team also looks to collaborate with the Ministry of Health Office for Healthcare Transformation and investors to seek help in scaling the reach of their technology. WHY IT MATTERS Diabetic foot ulcers can afflict a third of patients living with diabetes. When left untreated, it can lead to lower limb amputation and increase the risk of death. It also has a high reoccurrence rate, further burdening patients with recurring costs of medication. According to the WellFeet research group led by Nanyang Technological University, existing apps for diabetes patients in the market do not include education and commonly focus on measuring ulcer progression. Patient education, they said, is a crucial component of effective prevention. What sets their app apart is how education is delivered through animations in multiple languages, catering to multi-ethnic populations. MARKET SNAPSHOT Podimetrics from the United States is an established player in the diabetic foot monitoring space with its connected platform called SmartMat. A similar monitoring technology has been developed by researchers from New Zealand recently. Dubbed FootSense, the device measures irregularities in the temperature of patients with Type 2 diabetes to detect early signs of foot complications.

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.libproxy1.nus.edu.sg/articles/s41598-023-41882-z The content above comes from the network. if any infringement, please contact us to modify.