Miller, J. D., Salloum, M., Button, A., Giovinco, N. A., & Armstrong, D. G. (2014). How Can I Maintain My Patient With Diabetes and History of Foot Ulcer in Remission? The International Journal of Lower Extremity Wounds. doi:10.1177/1534734614545874
Patients with diabetes and previous history of ulceration occupy the highest category of risk for reulceration and amputation. Annual recurrence rates of diabetic ulcerations have been reported as high as 34%, 61%, and 70% at 1, 3, and 5 years, respectively, with studies reporting 20% to 58% recurrence rate within 1 year. As the ever growing epidemic of diabetes expands globally, this sequelae of diabetic complication will continue to require increasing resources from the healthcare community to effectively manage. Recent data suggest that removal of preventative podiatric care from statewide reimbursement systems lead to significant and sustained increases in hospital admission (37%), charges (38%), length of stay (23%), and severe aggregate outcomes including amputation, sepsis and death (49%). The addition of comorbidities such as peripheral artery disease, poor nutrition, and non-adherence to preventive therapies not only increase a patient's likelihood for ulcer recurrence, but also cost of care and certainty of hospital admission. Currently, numerous efforts, guidelines, and industry generated products exist to prolong remission from ulceration; however, the clinical science for treating this patient population calls for much more effort. Despite this, data continue to suggest to demonstrate that appropriate follow-up care, shoe and insole modification, and patient education play a central role in reducing reulceration and amputation. Novel modalities for offloading and wearable sensor technologies offer the advantage of round-the-clock, patient specific and active response healthcare. These have the potential to detect, or even prevent, many wounds before they begin.
Armstrong, D. G., Rankin, T. M., Giovinco, N. A., Mills, J. L., & Matsuoka, Y. (2014). A Heads-Up Display for Diabetic Limb Salvage Surgery: A View Through the Google Looking Glass. Journal of diabetes science and technology. doi:10.1177/1932296814535561
Although the use of augmented reality has been well described over the past several years, available devices suffer from high cost, an uncomfortable form factor, suboptimal battery life, and lack an app-based developer ecosystem. This article describes the potential use of a novel, consumer-based, wearable device to assist surgeons in real time during limb preservation surgery and clinical consultation. Using routine intraoperative, clinical, and educational case examples, we describe the use of a wearable augmented reality device (Google Glass; Google, Mountain View, CA). The device facilitated hands-free, rapid communication, documentation, and consultation. An eyeglass-mounted screen form factor has the potential to improve communication, safety, and efficiency of intraoperative and clinical care. We believe this represents a natural progression toward union of medical devices with consumer technology.
Rankin, T. M., Giovinco, N. A., Cucher, D. J., Watts, G., Hurwitz, B., & Armstrong, D. G. (2014). Three-dimensional printing surgical instruments: are we there yet? The Journal of surgical research. doi:10.1016/j.jss.2014.02.020
BACKGROUND: The applications for rapid prototyping have expanded dramatically over the last 20 y. In recent years, additive manufacturing has been intensely investigated for surgical implants, tissue scaffolds, and organs. There is, however, scant literature to date that has investigated the viability of three-dimensional (3D) printing of surgical instruments. MATERIALS AND METHODS: Using a fused deposition modeling printer, an Army/Navy surgical retractor was replicated from polylactic acid (PLA) filament. The retractor was sterilized using standard Food and Drug Administration approved glutaraldehyde protocols, tested for bacteria by polymerase chain reaction, and stressed until fracture to determine if the printed instrument could tolerate force beyond the demands of an operating room (OR). RESULTS: Printing required roughly 90 min. The instrument tolerated 13.6 kg of tangential force before failure, both before and after exposure to the sterilant. Freshly extruded PLA from the printer was sterile and produced no polymerase chain reaction product. Each instrument weighed 16 g and required only $0.46 of PLA. CONCLUSIONS: Our estimates place the cost per unit of a 3D-printed retractor to be roughly 1/10th the cost of a stainless steel instrument. The PLA Army/Navy retractor is strong enough for the demands of the OR. Freshly extruded PLA in a clean environment, such as an OR, would produce a sterile ready-to-use instrument. Because of the unprecedented accessibility of 3D printing technology world wide and the cost efficiency of these instruments, there are far reaching implications for surgery in some underserved and less developed parts of the world.
Miller, J. D., Hua, N. T., Giovinco, N. A., Armstrong, D. G., & Mills, J. L. (2014). The SALSA spike: A novel technique using Kirschner wires to anchor tenuous midfoot and forefoot amputation flaps. Wound Medicine, 4(0), 13–18.
Extensive tissue resection often mandates unique approaches to complete a functional reconstruction. While there are numerous options for selecting a donor site for a skin or soft tissue flap, available options for securing a local flap following midfoot amputation are quite limited. Adequate flap fixation is essential to maintain its viability, yet this may be challenging to achieve when there is a substantial residual post debridement requiring coverage and only limited remaining viable surrounding soft tissue available for anchoring. Over thinning the flap may compromise vital circulation to it from plantar (or other pertinent) artery perforators. In our experience, the adjunctive use of Kirschner wire(s) to support external soft-tissue fixation in conjunction with traditional methods has been successful in securing such tenuous fasciocutaneous flaps. To our knowledge, few alternative techniques have been described to fasten flaps in instances of compromised surrounding skin and soft tissue integrity in high-risk patients. This technique offers the surgeon a strong, inexpensive, and versatile solution for soft tissue anchoring. It allows for mechanical creep and ultimately stress relaxation at a potential wound closure site. This manuscript reviews several cases, each using this simple, novel approach to fixate an unsecured flap during the closure of an open amputation.
Miller, J. D., Giovinco, N. A., Mills, J. L., & Armstrong, D. G. (2014). The Diabetic-Foot Online Clinic Utilization Score (DFOCUS): A calculator for estimating clinic volume and utilization. Wound Medicine, 4(0), 19–20.
The goal of this manuscript is to suggest the utilization of pre-existing population data to provide a functional tool for health systems and administrators to best estimate and plan resource utilization when building or refining a diabetic foot clinic. The system allows one to predict the number of expected risk-category specific visits from a local community in a given year. It is our hope that this system will aid health care providers in administrative planning and overhead. The calculator is hosted at http://www.diabeticcalculator.com as a free to use operation.
Miller, J. D., Zhubrak, M., Giovinco, N. A., Mills, J. L., & Armstrong, D. G. (2014). The Too Few Toes principle: A formula for limb-sparing low-level amputation planning. Wound Medicine, 4(0), 37–41.
Both single and multiple toe amputations biomechanically alter foot function to varying degrees. In patients with diabetic neuropathy, these changes often lead to increases in deformity, plantar pressure and risk for ulceration, infection and reamputation. While a philosophy that strives to maximize limb length and function by performing the fewest and most distal amputations possible is likely a good one, we believe that a basic “formula” might help serve as a guide for surgeons to balance limb function with tissue preservation. Digital amputations that exceed a “hallux plus one lesser toe” or “lesser toe plus two” digital/ray amputations in our experience often surpass a threshold of mechanical function. For any clinical scenario in which amputation would extend beyond this threshold, a transmetatarsal amputation (TMA) or pan metatarsal head resection (PMHR) should strongly be considered to avoid costly foot complications and the need for excessive revisional surgery. Such an approach still maintains an underlying philosophy of functional limb preservation. We are unaware of any other attempt to standardize the advancement of surgical intervention from multiple toe resections to a full metatarsal level or higher resection. Therefore, we present this simple formula for surgical planning in the hopes of providing the most durable and efficient care of the high-risk diabetic foot when multiple toe amputations are needed.
Rose, J. F., Giovinco, N., Mills, J. L., Najafi, B., Pappalardo, J., & Armstrong, D. G. (2014). Split-thickness skin grafting the high-risk diabetic foot. Journal of vascular surgery. doi:10.1016/j.jvs.2013.12.046
OBJECTIVE: The application of split-thickness skin grafts (STSGs) to chronic extremity wounds has often been considered undesirable because of the perceived high incidence of failure, especially in neuropathic patients with plantar diabetic foot wounds. The purpose of this study was to evaluate the outcomes of STSG placement in patients with chronic lower extremity wounds. METHODS: We abstracted data from consecutive patients at our institution from January 2007 through April 2013 who underwent STSG placement by vascular and podiatric surgeons for chronic wounds of the lower limb and foot. Patients were monitored for at least 24 weeks, unless the wounds healed sooner. RESULTS: There were 94 patients (72% male) in the study group, with a mean age of 61.0 ± 12.8 years. Of these, 66 patients had diabetes, including 13 who were dialysis-dependent; the remaining 28 had other chronic nondiabetic wounds. The average duration of follow-up was 12.0 ± 12.9 months. After STSG placement, 65 (69.1%) experienced complete graft incorporation and healing, and 18 (19.1%) required revision, five (5.3%) of whom ultimately required major limb amputation. There were no differences in healing when wounds in patients with and without diabetes or plantar vs nonplantar wound locations were compared (P > .05). Similar results were observed after adjusting the results for initial wound size. Although dialysis patients had a threefold higher rate of STSG revision (46.2% vs 14.8%; P = .01), the cumulative rate of wound healing as a function of time was independent of end-stage renal disease (P = .83). CONCLUSIONS: The results of this study suggest that STSG may be an effective method for promotion of wound healing in the management of chronic lower extremity wounds irrespective of wound location and presence of diabetes.
Weinstein, R. B., Taylor, G. C., & Giovinco, N. A. (2013). Use of tensioned olive wires through a neutralization plate for syndesmotic reduction. The Journal of foot and ankle surgery: official publication of the American College of Foot and Ankle Surgeons, 53(1), 75–78.
Ankle fractures are a common osteologic outcome from trauma. These fracture patterns include a variety of concomitant soft tissue disruptions, including diastasis. Surgical treatment of a syndesmotic injury can be performed in conjunction with open reduction with internal fixation. The present technique guide demonstrates the use of pre-existing hardware, after open reduction with internal fixation from a previous ankle fracture, with an Ilizarov fixation construct to percutaneously reduce a bimalleolar equivalent fracture and diastasis to the syndesmosis.
Giovinco, N. A., Dunn, S. P., Dowling, L., Smith, C., Trowell, L., Ruch, J. A., & Armstrong, D. G. (2012). A novel combination of printed 3-dimensional anatomic templates and computer-assisted surgical simulation for virtual preoperative planning in Charcot foot reconstruction. The Journal of foot and ankle surgery: official publication of the American College of Foot and Ankle Surgeons, 51(3), 387–393.
Charcot foot syndrome (Charcot neuroarthropathy affecting the foot), particularly in its latter stages, may pose a significant technical challenge to the surgeon. Because of the lack of anatomic consistency, preoperative planning with virtual and physical models of the foot could improve the chances of achieving a predictable intraoperative result. In this report, we describe the use of a novel, inexpensive, 3-dimensional template printing technique that can provide, with just a normal printer, multiple “copies” of the foot to be repaired. Although we depict this method as it pertains to repair of the Charcot foot, it could also be used to plan and practice, or revise, 3-dimensional surgical manipulations of other complex foot deformities.
Armstrong, D. G., Giovinco, N., Mills, J. L., & Rogers, L. C. (2011). FaceTime for Physicians: Using Real Time Mobile Phone-Based Videoconferencing to Augment Diagnosis and Care in Telemedicine. Eplasty, 11, e23.
Objective/Background: Telemedicine has, even in its infancy, had an impact on the provision of healthcare, particularly in rural communities. However, this often relies on an expensive and ponderous infrastructure that reduces the rapid use and spontaneity for consultations. Methods: Using postoperative and intraoperative examples, we describe the use of one rapid and widely available technology (iPhone FaceTime, Cupertino, California). Results: The device, in allowing “one button connection” similar to making a phone call, reduced the need for preplanning that is generally required for real-time telemedicine consultation. Conclusions: The ability to communicate quickly with something that is an afterthought has the potential to alter how we work with our colleagues and patients. Just as with the iPod in music and the laptop in computing, it is not the change in technology, but the change in form factor and ubiquity that alters this landscape.
Armstrong, D. G., & Giovinco, N. A. (2011). Diagnostics, theragnostics, and the personal health server: fundamental milestones in technology with revolutionary changes in diabetic foot and wound care to come. Foot & ankle specialist, 4(1), 54–60.
Over the past generation, significant advances in care have led to reductions in amputation worldwide. However, it may be argued that the most potent advances in healing have been in organization of care. Technologies are now emerging that may allow further enhancements of organization and integration of care while also bringing in much needed bedside, chairside, and in-home diagnostics to identify key points in healing and potential early warning signs for recurrence. This article reviews what are believed to be 6 key areas of change over the next generation. These include portability, durability, automation, intelligence, ubiquity, and afford-ability, all yielding specific advances in wound diagnostics. The authors believe that devices will be organized into personal health servers in cloud-synchronized devices already existing in the home (eg, a scale), the clinic, and on (or in) the patient.
Scimeca, C. L., Bharara, M., Fisher, T. K., Giovinco, N., & Armstrong, D. G. (2010). Novel use of doxycycline in continuous-instillation negative pressure wound therapy as “wound chemotherapy.” Foot & ankle specialist, 3(4), 190–193.
Negative-pressure wound therapy (NPWT) is frequently employed in the treatment of complex wounds. The authors present a description of real-time streaming therapy of a variety of wound chemotherapeutic agents through NPWT. Doxycycline, which acts as a competitive inhibitor of matrix metalloproteinases and tumor necrosis factor alpha and further decreases inflammation through the reduction of nitrous oxide production, may prove helpful when delivered in this manner. To the authors’ knowledge, this is the first report in the literature describing this method of delivery of doxycycline.
INTRODUCTION: Although the use of negative pressure wound therapy (NPWT) is broadly efficacious, it may foster some potentially adverse complications. This is particularly true in patients with diabetes who have a wound colonized with aerobic organisms. Traditional antiseptics have been proven useful to combat such bacteria but require removal of some NPWT devices to be effective. METHODS: In this article, we describe a method of “wound chemotherapy” by combining NPWT and a continuous infusion of Dakins’ 0.5% solution either as a standardized technique in one device (ITI Sved) or as a modification of standard technique in another (KCI VAC) NPWT device. The twin goals of both techniques are to effectively reduce bacterial burden and to promote progressive wound healing. RESULTS: We present several representative case examples of our provisional experience with continuous streaming therapy through 2 foam-based negative pressure devices. DISCUSSION: Wound chemotherapy was successfully applied to patients with diabetes, without adverse reactions, complications, or recolonization during the course of treatment. We believe this to be a promising method to derive the benefits of NPWT without the frequent adverse sequela of wound colonization.