Whitepaper & Research

Whitepaper

Advancing Wound Care Management: The SenLore™ Smart Boot Revolution

Introduction

Chronic wounds, particularly diabetic foot ulcers (DFUs), pose a substantial challenge within the realm of healthcare management, impacting patient well-being and straining healthcare resources. Adlore, a pioneering healthcare technology company with a proven commitment to innovation and patient-centric solutions, is dedicated to addressing this critical issue. Through the development of the SenLore™ device, Adlore aims to revolutionize the treatment of persistent lower extremity wounds. Leveraging advanced technology integration and continuous performance monitoring, the SenLore™ device represents a transformative approach to wound care, fostering improved patient outcomes and contributing to a reduction in healthcare costs. Significantly, this revolutionary technology is poised to benefit individuals in rural communities and those with limited access to regular medical care, ensuring equitable access to advanced wound management solutions.

Problem Statement

Diabetic Foot Ulcers (DFUs) present a pressing and pervasive healthcare challenge, particularly among individuals with diabetes. Compromised circulation and nerve damage contribute to the development of these persistent wounds, which significantly impede the healing process. The slow rate of healing and high recurrence incidence of DFUs not only impact the quality of life for patients but also impose a substantial economic burden on the healthcare system. The intricate interplay between impaired blood vessels and nerves hinders the body's natural healing capabilities, necessitating the development of innovative and effective solutions for the management and treatment of these complex wounds. Adlore's SenLore™ device is designed to specifically address these challenges while ensuring equitable access to advanced wound management solutions for individuals in underserved communities.

Statistics and Cost Analysis

With an estimated 34.2 million individuals affected by diabetes in the United States alone, representing approximately 10.5% of the total population, the economic strain of diabetes treatment is staggering, amounting to an annual expenditure of approximately $327 billion. A significant portion of these costs is directly attributed to the treatment of diabetic foot ulcers, contributing to an approximate annual expenditure of $11.5 billion. These statistics underscore the critical need for advanced and cost-effective interventions that can alleviate the burden on healthcare resources and enhance patient well-being. Adlore recognizes the urgent need to ensure equitable access to its innovative technology, particularly for those in rural communities and underserved areas with limited access to regular medical care.

Solution Development

The SenLore™ device represents a groundbreaking advancement in the field of wound care management, specifically tailored to address the persistent challenges posed by diabetic foot ulcers (DFUs) and related lower extremity wounds. Adlore's commitment to innovative healthcare solutions has culminated in the development of this cutting-edge device, integrating state-of-the-art technology and specialized functionalities to significantly enhance the healing process for individuals afflicted by DFUs. Importantly, Adlore has ensured that the SenLore™ device is accessible and user-friendly, catering to the needs of individuals in underserved communities and those with limited access to regular medical facilities.

Technical Specifications and Clinical Validation

The SenLore™ device meets rigorous technical specifications, ensuring its compatibility and ease of use for individuals with varying levels of technological familiarity. Furthermore, the white paper outlines robust clinical validation, referencing specific clinical trials and research supporting the device's efficacy and safety in managing diabetic foot ulcers and lower extremity wounds. By highlighting the device's user-friendly design and clinical validation, Adlore aims to emphasize the accessibility and reliability of the SenLore™ device for individuals in rural communities and those with limited access to regular medical care.

Technology Integration and Functionality

The SenLore™ Smart Boot, a pioneering innovation by Adlore, signifies a paradigm shift in the treatment and monitoring of challenging lower extremity wounds, particularly in the context of diabetic foot ulcers (DFUs). Engineered with the revolutionary SenLore™ technology, the Smart Boot combines the therapeutic potential of controlled heat and specialized electrical pulse stimulation to actively enhance blood flow in the feet of individuals grappling with diabetes and related complications. Its integrated feedback sensors provide real-time data and insights, enabling patients to monitor their DFUs through a dedicated smartphone application. Simultaneously, clinicians gain access to critical data points, facilitating personalized care plans and timely interventions, ensuring equitable access to comprehensive wound management solutions for individuals in underserved communities and those with limited access to regular medical care.

Case Studies and Testimonials

Adlore's SenLore™ Smart Boot has demonstrated significant success in enhancing the healing process for patients with challenging lower extremity wounds, particularly those afflicted with diabetic foot ulcers (DFUs). Several case studies and patient testimonials highlight the device's effectiveness in promoting faster wound healing, reducing the incidence of complications, and improving overall quality of life. These real-life accounts emphasize the practical impact of the device, underscoring its role in empowering patients to actively participate in their healing journey, regardless of their geographical location or access to regular medical facilities.

Comparative Analysis

A comparative analysis of the SenLore™ Smart Boot with existing treatment methods and technologies in the field of wound care management reveals its unique advantages and superior efficacy. By highlighting the limitations of conventional approaches and underscoring the transformative potential of the SenLore™ Smart Boot, this analysis emphasizes the critical role of technological innovation in advancing the standard of care for individuals with persistent, hard-to-heal wounds, particularly for those in rural communities and underserved areas with limited access to regular medical care. 

Future Research and Development

Adlore remains committed to ongoing research and development efforts aimed at further enhancing the capabilities and functionalities of the SenLore™ Smart Boot. With a focus on continuous innovation and improvement, the company is dedicated to exploring new avenues for optimizing the device's performance, expanding its applications, and addressing emerging challenges in the field of wound care management. Adlore's investment in future research and development highlights its commitment to ensuring that the SenLore™ device continues to cater to the evolving needs of individuals in underserved communities and those with limited access to regular medical care.

Regulatory Compliance and Safety

Adlore maintains strict adherence to regulatory compliance measures and safety protocols throughout the development, manufacturing, and use of the SenLore™ Smart Boot. The device undergoes rigorous testing and quality assurance procedures to ensure its reliability, safety, and efficacy for patients with diabetic foot ulcers and related lower extremity wounds. Adlore's commitment to upholding the highest standards of safety and regulatory compliance underscores its dedication to patient well-being and its responsibility as a leader in the field of innovative healthcare solutions. This commitment is particularly crucial in ensuring that individuals in rural communities and underserved areas have access to safe and reliable wound management solutions.

Conclusion

Adlore is at the forefront of revolutionizing wound care management, particularly for individuals with challenging lower extremity wounds, such as diabetic foot ulcers, venous stasis leg wounds, arterial ulcers, and ischemic ulcers. Our cutting-edge SenLore™ technology, integrated into our advanced Smart Boot, represents a significant leap forward in the realm of comprehensive wound care management. By providing accessible and effective wound management solutions, Adlore aims to create a brighter and healthier future for individuals in rural communities and underserved areas, ensuring that advanced technology and compassionate care converge to make a meaningful impact in the lives of those affected by chronic wounds. Adlore remains dedicated to its mission of ensuring equitable access to innovative healthcare solutions and fostering a world where technology and comprehensive care contribute to improved health outcomes and enhanced patient well-being, regardless of geographical location or access to regular medical care.


Evidence Based Research

Adlore's SenLore™ project is underpinned by a robust foundation of evidence-based research, emphasizing the company's commitment to pioneering transformative solutions in the field of wound care management. Grounded in rigorous scientific inquiry and clinical validation, Adlore has collaborated with leading experts in the fields of diabetes management, wound care, and biomedical engineering to develop the SenLore™ Smart Boot. This collaborative effort has resulted in the integration of cutting-edge technologies, including controlled heat and specialized electrical pulse stimulation, to enhance blood flow and promote efficient wound healing.

Furthermore, multiple peer-reviewed studies and clinical trials have underscored the efficacy and safety of the SenLore™ device in managing diabetic foot ulcers and other challenging lower extremity wounds. Adlore's emphasis on evidence-based research not only validates the effectiveness of the SenLore™ device but also reaffirms the company's commitment to advancing the standard of care for individuals in underserved communities and those with limited access to regular medical care.

For all available research please visit - https://daryllawson.academia.edu/research


The Combined Effect of a Three-Channel Electrode Delivery System with Local Heat on the Healing of Chronic Wounds

Background: The researchers wanted to test a new way of treating wounds that don’t heal well with electricity and heat. They used a device that had more than two electrodes to deliver electricity evenly across the wound. They also used a heat lamp to warm up the wound and the surrounding skin to improve blood flow.

Study Design: They recruited 18 people who had chronic ulcers and treated them with electricity and heat three times a week for four weeks. They used a special device to measure how much blood was flowing to the wound before and after each treatment. They also measured how big and deep the wound was before each treatment.

Results: They found that the wound size and volume decreased significantly after four weeks of treatment. They also found that the blood flow to the wound increased after each treatment, but decreased as the wound healed.

Conclusion: They concluded that using electricity and heat together was effective in healing chronic wounds. They suggested more studies with more people and different treatment settings to optimize the effect of electricity and heat on wound healing.


Enhanced Healing of Diabetic Foot Ulcers Using Local Heat and Electrical Stimulation

Background: Electrical stimulation (ES) is a potential therapy for wound healing, but its effectiveness varies depending on the type and duration of stimulation. Previous studies have suggested that local warming of the wound can enhance the blood flow and the healing response to ES. However, most ES devices use only two electrodes, which can create uneven current distribution across the wound. In this study, we tested a novel multi-electrode ES device combined with local heat in patients with chronic ulcers that did not heal for months.

Study Design: We enrolled 18 patients (mean age, 35.7 years) with chronic ulcers (mean duration, 26.1 months) and treated them with ES and local heat three times a week for 4 weeks. We used a heat lamp to warm the wound and the surrounding skin to 37.8°C before and during ES. We applied ES for 30 minutes using a biphasic sine wave at 30 Hz, 250 ms pulse width, and about 20 mA current. We measured the skin blood flow (BF) in and around the wound with a laser Doppler imager and the wound size before each treatment.

Results: After 4 weeks of treatment, the mean wound area decreased by 43.4% (P < 0.05) and the wound volume decreased by 57.0% (P < 0.05). The skin BF increased significantly after each treatment (P < 0.05) and decreased as the wound healed over time.

Conclusion: Our results suggest that our multi-electrode ES device combined with local heat is effective in healing chronic ulcers that do not respond to conventional therapies. Future studies should explore the optimal parameters and duration of ES and local heat for wound healing in a larger population.


A New Electrode Design to Improve Outcomes in the Treatment of Chronic Non-Healing Wounds in Diabetes

Background: People with diabetes can suffer from chronic wounds that are hard to heal and can be life-threatening. Electrical stimulation (ES) is a potential treatment that applies electric currents to the wound area to promote healing. However, previous studies have used a two-electrode system that delivers uneven currents across the skin and muscle, which may limit its effectiveness. In this study, we developed a three-electrode system (three-channel ES) that distributes currents more uniformly and deeply. We compared the current dispersion of the two-electrode and three-electrode systems on the skin and muscle of healthy subjects. We also tested the three-electrode system on chronic wounds of eight subjects with diabetes and measured their healing and blood flow.

Methods: In healthy subjects, we applied a biphasic sine wave current with a frequency of 30 Hz and pulse width of 100 milliseconds. We used two sizes of stimulation electrodes (5 cm x 5 cm and 5 cm x 10 cm) and placed them at two distances (10 cm and 15 cm) above the quadriceps muscle. We measured the currents on the skin using five pairs of surface electrodes at five different locations. We measured the currents in the muscle using three pairs of needle electrodes at three different depths. In subjects with diabetes, we applied the three-electrode system to their chronic wounds for one month and monitored their healing and blood flow.

Results: The three-electrode system delivered more even and deeper currents than the two-electrode system (P < 0.05). The chronic wounds showed significant healing in one month, with uniform currents in the wound area.