SBIR-STTR Award

Venous leg ulcers (VLUs) are the most common ulcerative wounds in the elderly affecting 1.7% of all individuals older than 65. More than 650,000 elderly individuals suffer from VLUs, which cost nearly $10,000 USDs to treat a single ulcer. The overall cost to the medical system is $2 billion USDs yearly. Although there have been significant advances in the science of wound care including the development of novel bioengineered wound products, there remains significant uncertainty over the judicious use of these expensive treatments. Given the inherent differences of aged skin in regards to wounding and healing, even less is known in regards to optimal strategies for treating VLUs in the elderly. In contrast, therapeutic compression garments are widely accepted as the standard of care to at least double the speed of VLU healing compared to placebo. Numerous well-designed clinical studies have demonstrated the clinical value, safety, and cost-effectiveness of compression garments when used consistently and with sufficient pressure delivery (>30 mmHg) to prevent and heal VLUs. Currently, there is a lack of clinical tools able to provide clinicians and patients with important diagnostic information regarding the pressure being delivered by compression stockings that is sensitive to limb volume changes over time. Existing pressure sensors are bulky, expensive, and inaccurate. They are not conducive to wearable use given a lack of wireless communication. This has limited these devices to only select research applications. Thus, there is a critical clinical need for a wearable diagnostic tool that is able to provide accurate, and repeatable measurements of pressure and temperature that poses no risk to vulnerable lower extremities. Pressure measurements can be used by both trained clinical staff and the patient to adjust compression garments to ensure adequate pressure delivery. Temperature is useful to assess patient adherence but also serve as an independent marker of skin inflammation and wound risk. The proposed work addresses this need with a breakthrough sensor technology. The ultra-thin device incorporates an embedded pressure and temperature sensor within a soft, flexible silicone encapsulation. There is no rigid edges, thus eliminating the risk of skin injury to highly vulnerable lower limbs. By using near field communication paired to existing smartphones, the technology is battery-less, and wireless enabling a favorable cost profile and disposable use. Activities in Phase I will establish the accuracy of the sensors through systematic testing, and pilot testing with elderly individuals ages 65 years or older with a history of or active VLUs.  

Public Health Relevance Statement:
PROJECT​ ​NARRATIVE The​ ​goal​ ​of​ ​this​ ​project​ ​is​ ​to​ ​develop​ ​a​ ​wearable​ ​point-of-care​ ​system​ ​using​ ​a​ ​skin-integrated, soft,​ ​and​ ​ultra-thin​ ​pressure​ ​and​ ​temperature​ ​sensor​ ​to​ ​equip​ ​clinicians,​ ​specifically​ ​nursing professionals,​ ​and​ ​patients​ ​with​ ​the​ ​knowledge​ ​that​ ​any​ ​given​ ​compression​ ​garment​ ​is delivering​ ​adequate​ ​therapeutic​ ​pressure.​ ​The​ ​sensor​ ​within​ ​this​ ​system​ ​uses​ ​cutting​ ​edge materials​ ​science​ ​innovations​ ​and​ ​mechanical​ ​engineering​ ​optimization​ ​to​ ​ensure​ ​the​ ​ability​ ​to accurately​ ​detect​ ​low​ ​pressures​ ​associated​ ​with​ ​compression​ ​garments​ ​while​ ​still​ ​maintaining high​ ​user​ ​comfort.​ ​With​ ​clinical​ ​dissemination,​ ​this​ ​solution​ ​will​ ​reduce​ ​the​ ​time​ ​of​ ​healing​ ​for venous​ ​leg​ ​ulcers,​ ​a​ ​condition​ ​that​ ​disproportionately​ ​affect​ ​the​ ​elderly,​ ​and​ ​reduce​ ​overall costs.

Project Terms:
Address; Adherence; Adult; Affect; Age; age difference; Aging; Air Sacs; American; Anatomy; Atrophic condition of skin; Biomedical Engineering; Blood flow; Blood Vessels; Caring; Cellular Phone; Clinical; clinical practice; Clinical Research; Communication; companion diagnostics; Companions; Compliance behavior; Compression Stocking; Consensus; cost; cost effective; cost effectiveness; Deep Vein Thrombosis; design; Development; Devices; Diagnostic; Discipline of Nursing; Disease; Edema; Elderly; Engineering; Ensure; Feeling; flexibility; Goals; Gold; Hardness; healing; Health Personnel; Home environment; Hour; Human; Impaired wound healing; Imprisonment; improved; in vivo; Individual; Inflammation; innovation; interest; Intervention; irritation; Ischemia; keratinocyte; Knowledge; Lead; Leg Ulcer; Limb structure; Lower Extremity; Lymphedema; materials science; Measurement; Measures; Mechanics; Medical; Medicine; migration; Monitor; Muscle; novel; Observational Study; older patient; operation; Operative Surgical Procedures; Output; Pain; Patients; Performance; peripheral blood; Phase; Pilot Projects; Placebos; point of care; Point-of-Care Systems; pressure; prevent; Probability; Protocols documentation; psychologic; Pump; Quality of life; Recording of previous events; Recurrence; Reference Standards; Research; Resolution; response; Risk; Safety; Science; sensor; sensor technology; Silicones; Skin; Skin Aging; Sk