Working with Industry.

In 1992, I completed a 9-year dual-degree program where I received both my DPM degree and a PhD in Bioengineering. Upon my graduation, it was apparent that "Industry" had an interest in me. Sponsored research and consulting opportunities where readily available, and I had to learn very quickly to sort the scientific from the sham, and the clinically worthwhile from the worthless. Partnering with Industry has provided me with another avenue to advance my profession, while helping to develop new treatment options that can potentially help many more patients then just the ones I see in my office.

The Economic Impact of Living Cell Tissue Products in Treating Diabetic Foot Ulcers and Venous Leg Ulcers in Patients with Commercial Insurance: A Retrospective Matched-Cohort Study.

OBJECTIVE: Previous studies demonstrated that costs paid on behalf of Medicare recipients for diabetic foot ulcers and venous leg ulcers treated with cellular and/or tissue-based products (CTPs) varied in part based on the CTP chosen. This study extends previous work to determine how costs vary when paid by commercial insurance carriers. METHODS: A retrospective matched-cohort intent-to-treat design was used to analyze commercial insurance claims data between January 2010 and June 2018. Study participants were matched using Charlson Comorbidity Index, age, sex, type of wound, and geographic location within the US. Patients treated with a bilayered living cell construct (BLCC), dermal skin substitute (DSS), or cryopreserved human skin (CHSA) were included. RESULTS: Wound-related costs and number of CTP applications were significantly lower for CHSA relative to BLCC and DSS at all time intervals (60, 90, and 180 days and 1 year after first application of the CTP). Further, CHSA was associated with significantly fewer amputations at 1 year relative to DSS (14.9% vs 19.7%, P = .03). CONCLUSIONS: There was a statistically significant reduction in cost of treating diabetic foot ulcers (BLCC, DSS, CHSA) and venous leg ulcers (BLCC, CHSA) with CHSA as compared with the other CTPs. These findings are attributed to fewer applications, lower wound care costs, and comparable or reduced incidence of amputation. These commercial insurance data are consistent with prior studies that examined Medicare expenditures.

Visualization of Wound Healing Progression With Near Infrared Spectroscopy: A Retrospective Study.

OBJECTIVE: The aim of this retrospective study is to determine if near infrared spectroscopy (NIRS) can be used to evaluate wounds and adjacent soft tissues to identify patterns involved in tissue oxygenation and wound healing as well as predict which wounds may or may not heal. MATERIALS AND METHODS: In this study, 25 patients with either diabetic foot ulcers or venous leg ulcers were examined retrospectively to determine if NIRS could be used to predict which wounds may or may not close. All patients had either diabetic or venous ulcers and were being actively treated in the clinic. Regardless of the treatment rendered, all wounds were tracked with NIRS at regular intervals. Retrospectively, the de-identified images were reviewed to determine any patterns that might exist. Wound bed and periwound oxygenation patterns were observed and classified, including correlation with both the clinical appearance and the NIRS images. Images of wounds that closed and those that did not were compared. RESULTS: Four distinct patterns of tissue oxygenation that appeared to have some value for predicting which wounds would heal, and which would not, were identified among the 25 patients. A mechanism has also been proposed to try to explain the patterns of healing observed; Hyperperfusion, Imbibition, Neovascularization, and Trailing (HINT) describes various aspects of these patterns. CONCLUSIONS: As with any imaging technology, both qualitative and quantitative data are used to determine what is happening clinically. This study represents an early attempt to understand the role of NIRS and percent oxygenated hemoglobin in the wound healing process. It also lays the groundwork for identifying patterns associated with wound closure.

Treatment of Deep Full-thickness Wounds Containing Exposed Muscle, Tendon, and/or Bone Using a Bioactive Human Skin Allograft: A Large Cohort Case Series.

BACKGROUND: Deep wounds with exposed muscle, tendon, and/or bone structures are especially difficult to treat, often requiring a multifaceted approach. Bioactive human skin allograft (BSA) has been proven to be effective in the treatment of deep wounds, but the mechanism of action and clinical use in the real-world setting is not as well known. OBJECTIVE: The aim of this case series is to study deep wounds treated with BSA to better understand how it is used in real-world patients and discuss its mechanism of action. MATERIALS AND METHODS: A total of 51 deep wounds of various etiologies and locations were included from 10 sites across the United States. To be included, patients must have failed wound care without BSA for at least 30 days, with more than 50% reduction in size prior to BSA application. RESULTS: The mean wound area was 50.37 cm2 and average wound duration was 3.67 months. The mean time to closure was 15.33 weeks, achieved with an average of 4.24 BSA applications. Many patients received adjunctive therapies either prior to or in combination with BSA. CONCLUSIONS: This study demonstrates the effectiveness of BSA in the treatment of deep wounds of various etiologies. The authors provide clinical information on using BSA either alone or in conjunction with other advanced modalities and offer insight into the hypothesized mechanism of action in which these grafts become incorporated. Ultimately, this information can guide best practices in the treatment of full-thickness wounds to improve outcomes.

Intra-Articular Calcaneal Fractures: A Literature Review of Atraumatic Incisional Considerations.

When calcaneal fractures occur, the treating physician is faced with many decisions that are required to bring about a good clinical outcome. From a surgical perspective, decisions must be made regarding whether or not fixation is necessary, and if so, what will be used. Implicit in that thought process is planning of the surgical approach. This article shows that there are numerous considerations, including the level of edema, condition of the soft tissue envelope, posttrauma time, and circulation. These factors should play a significant role in planning the surgical incision, and may dictate the repair options available to the surgeon.

Preclinical and Clinical Studies of Hyaluronic Acid in Wound Care: A Case Series and Literature Review.

INTRODUCTION: Esterified hyaluronic acid is part of a unique dressing that can be used for the treatment of difficult, nonprogressive wounds, including venous leg ulcers (VLUs) and diabetic foot ulcers (DFUs). OBJECTIVE: The data presented herein represent a small retrospective sample of the authors' clinical experience with this unique material. MATERIALS AND METHODS: Data were collected from 6 patients with DFUs and 3 patients with VLUs. Patients were assessed at regular intervals, and the change in wound size as well as the percentage of necrotic versus granular tissue were tracked. RESULTS: The average time for evaluation was 55.25 days (SD = 2.76 days). During this period, the average change in wound size decreased by 6.43 cm2 (SD = 7.55 cm2), from 7.93 cm2 (SD = 8.12 cm2) to 1.50 cm2 (SD = 0.92 cm2), and developed an increase of 74.38% (SD = 32.01%) coverage with granulation tissue from 46.11% (SD = 22.05%), representing about a 50% increase in granulation tissue over the 55 days of evaluation. CONCLUSIONS: The presented literature supports the contention that hyaluronic acid is a critical component in the complex cascade of wound healing and most likely is responsible for the clinical wound improvement in the case series presented.

Complications Following Allograft and Xenograft Resurfacing of the First Metatarsal Head: A Case Series.

Ten cases using decellularized allografts and xenografts for the purpose of resurfacing the first metatarsal head are reviewed in this article. Although most of the cases were performed without any postoperative complications, the focus of this series is on 2 of the 3 cases in which destruction of the first metatarsal head was observed postoperatively due to a foreign body reaction and severe degeneration within the metatarsal head. A salvage procedure using a silicone total joint to replace the damaged surface is shown. The role of cystic changes present preoperatively, and its role in subsequent failure is examined.

Soft Tissue Reconstruction with Artelon for Multiple Foot and Ankle Applications.

Surgical repair of tendons of the foot and ankle is performed utilizing various methods, including autografts, allografts, and synthetic grafts. Artelon is a synthetic biomaterial that is fabricated from wet-spun fibers of PCL-based polyurethane urea, and has, optimal mechanical properties compared with other grafting options. Because of excellent results of Artelon in ACL reconstruction, its use was explored in 3 foot and ankle cases: repair of Achilles, posterior tibial, and peroneal tendons. Artelon has proven to be a successful alternative for tendon repairs, with all 3 cases returning to full function within 8 to 16 weeks and with no complications related to the graft.

Mesenchymal Stem Cell Applications for Joints in the Foot and Ankle.

The use of mesenchymal stem cell injections is a new approach to the treatment of painful joints, particularly in the foot and ankle. Previous studies performed in the knee have considered allogeneic and xenogeneic injections, and autologous cells expanded in culture. This article considers these applications and considers the possibility of performing these types of injections in the foot and ankle joints.

Near-Infrared Spectroscopy Imaging for Assessing Skin and Wound Oxygen Perfusion.

Near infrared spectroscopy (NIRS) is a technique whereby light is transmitted to the skin or the surface of a wound. Light is selectively absorbed or reflected in order to calculate the percentage of oxygenated and deoxygenated hemoglobin. By calculating this ratio, the level of tissue oxygen perfusion can be assessed. This article describes an NIRS imaging device and demonstrates its use as a clinical tool to predict future viability of skin flaps, potential for wound healing, and progress of closure following application of a biologic wound product. Several cases are examined.

Characterization of a Cryopreserved Split-Thickness Human Skin Allograft-TheraSkin.

OBJECTIVE: The purpose of this study was to examine the characteristics of a cryopreserved split-thickness skin allograft produced from donated human skin and compare it with fresh, unprocessed human split-thickness skin. BACKGROUND: Cutaneous wound healing is a complex and organized process, where the body re-establishes the integrity of the injured tissue. However, chronic wounds, such as diabetic or venous stasis ulcers, are difficult to manage and often require advanced biologics to facilitate healing. An ideal wound care product is able to directly influence wound healing by introducing biocompatible extracellular matrices, growth factors, and viable cells to the wound bed. MATERIALS AND METHODS: TheraSkin (processed by LifeNet Health, Virginia Beach, Virginia, and distributed by Soluble Systems, Newport News, Virginia) is a minimally manipulated, cryopreserved split-thickness human skin allograft, which contains natural extracellular matrices, native growth factors, and viable cells. The authors characterized TheraSkin in terms of the collagen and growth factor composition using ELISA, percentage of apoptotic cells using TUNEL analysis, and cellular viability using alamarBlue assay (Thermo Fisher Scientific, Waltham, Massachusetts), and compared these characteristics with fresh, unprocessed human split-thickness skin. RESULTS: It was found that the amount of the type I and type III collagen, as well as the ratio of type I to type III collagen in TheraSkin, is equivalent to fresh unprocessed human split-thickness skin. Similar quantities of vascular endothelial growth factor, insulinlike growth factor 1, fibroblast growth factor 2, and transforming growth factor ß1 were detected in TheraSkin and fresh human skin. The average percent of apoptotic cells was 34.3% and 3.1% for TheraSkin and fresh skin, respectively. CONCLUSIONS: Cellular viability was demonstrated in both TheraSkin and fresh skin.

Dual-Component Intramedullary Implant Versus Kirschner Wire for Proximal Interphalangeal Joint Fusion: A Randomized Controlled Clinical Trial.

We undertook a multicenter, parallel treatment arm, randomized controlled trial to compare the outcomes after surgery for the treatment of lesser digital hammertoe using either a Kirschner wire or a 2-piece intramedullary, stainless steel implant for fixation of the proximal interphalangeal joint. Our primary aim was to compare the incidence of arthrodesis and complications, and our secondary aim was to compare the subjective foot-related outcomes measured using the Bristol Foot Score and the Foot Function Index, stratified by fixation group. We hypothesized that the use of the dual-component implant would result in greater patient satisfaction, a greater incidence of radiographic arthrodesis, and fewer complications after hammertoe repair. The overall mean age of the participants was 58.72 ± 13.48 (range 18 to 84) years, their mean body mass index was 30.14 ± 6.55 (range 20.7 to 46.98) kg/m(2), and no statistically significant differences in the demographic variables were present between the treatment groups at baseline or during the follow-up period. Of the 91 participants, 46 (50.55%) were randomly allocated to the Kirschner wire group and 45 (49.45%) to the intramedullary implant group. No statistically significant differences were observed between the 2 fixation groups in the incidence of complications; however, the 2-piece intramedullary implant group was associated with a greater mean Bristol Foot Score and Foot Function Index score and a greater incidence of fusion.

American college of foot and ankle surgeons' clinical consensus statement: perioperative prophylactic antibiotic use in clean elective foot surgery.

Some controversy exists regarding the use of antibiotic prophylaxis in elective foot and ankle surgery. A task force was appointed by the American College of Foot and Ankle Surgeons (ACFAS) to provide a clinical consensus statement on this topic. The panel members performed a literature search and identified 6 studies that met the inclusion criteria. They then developed a list of 13 questions about which they attempted to reach consensus using a modified Delphi method. The questions were grouped into 4 categories: indications for antibiotic prophylaxis relative to surgical procedure; antibiotic prophylaxis in high-risk patients; antibiotic selection; and timing of antibiotic prophylaxis. Consensus was reached for all 13 questions. The panel members found that studies pertaining specifically to elective foot and ankle surgeries that were not level I evidence generally did not recommend prophylaxis. They also found that multispecialty guidelines, which reflect data that are stronger, tended to recommend routine prophylaxis, especially for surgeries involving hardware. In addition, many hospital systems support routine prophylaxis by surgeons. More high-level evidence is required to make a definitive determination about whether prophylaxis is necessary in elective foot and ankle surgery. Until that time, routine prophylaxis will likely be continued at most institutions, because few complications have been reported with the practice.

A prospective, multicenter, randomized, controlled clinical trial comparing a bioengineered skin substitute to a human skin allograft.

An estimated 25% of all people with diabetes may experience a foot ulcer in their lifetime, which may lead to serious complications including infection and amputation. A prospective, multicenter, randomized, controlled clinical trial was conducted to compare an in vitro-engineered, human fibroblast-derived dermal skin (HFDS) substitute and a biologically active cryopreserved human skin allograft (HSA) to determine the relative number of diabetic foot ulcers (DFUs) healed (100% epithelialization without any drainage) and the number of grafts required by week 12. Secondary variables included the proportion of healed patients at weeks 16 and 20, time to healing during the study, and wound size progression. The 23 eligible participants (11 randomized to the HSA, 12 to the HFDS group) were recruited from two hospital-based outpatient wound care centers. Baseline patient (body mass index, age, gender, race, type and duration of diabetes, presence of neuropathy and/or peripheral arterial disease, tobacco use) and wound characteristics (size and duration) were recorded, and follow-up visits occurred every week for up to 20 weeks. Descriptive and multivariate regression analyses were used to compare wound outcomes. At baseline, no statistically significant differences between patients and wounds were observed. At week 12, seven (63.6%) patients in the HSA and four (33.3%) in the HFDS group were healed (P = 0.0498). At the end of the 20-week evaluation period, 90.91% of HSA versus 66.67% of HFDS were healed (P = 0.4282). Among the subset of wounds that healed during the first 12 weeks of treatment, an average of 4.36 (range 2-7) HSA grafts were applied versus 8.92 (range 6-12) in the HFDS subset (P <0.0001, SE 0.77584). Time to healing in the HSA group was significantly shorter (8.9 weeks) than in the HFDS group (12.5 weeks) (log-rank test, P = 0.0323). The results of this study are similar to previous outcomes reported using these treatment modalities and suggest that, after 12 weeks of care, DFUs managed with HSA are approximately twice as likely to heal as DFUs managed with HFDS with approximately half the number of grafts required. Research confirming these results with a larger sample size and inpatients with different types of wounds is warranted.

A prospective, randomized, double-blinded study with crossover to determine the efficacy of radio-frequency nerve ablation for the treatment of heel pain.

BACKGROUND: Previous studies have demonstrated that radio-frequency nerve ablation (RFNA) can be an effective treatment for plantar fasciosis. This study provides additional evidence in support of this treatment, with statistically significant data that demonstrate the success of this technique. METHODS: In this multicenter, randomized, prospective, double-blinded study with crossover, 17 patients were divided into two groups, with eight initially receiving RFNA treatment and nine initially receiving sham treatment. If no improvement was observed after 4 weeks, a crossover was offered. Results of the treatment were evaluated by the patient and by a blinded physician using a visual analog pain scale to rate first-step pain, average pain, and peak pain in the heel region. RESULTS: We observed a statistically significant improvement in the symptoms of plantar fasciosis in patients actively treated with RFNA and no significant improvement in the sham-treated group. More important, those treated with sham subsequently demonstrated statistically significant improvement after subsequent RFNA treatment. CONCLUSIONS: Using a prospective, randomized study with sham treatment and crossover, this study demonstrates the efficacy of RFNA for the treatment of plantar fasciosis.

Treatment of mild, moderate, and severe onychomycosis using 870- and 930-nm light exposure: some follow-up observations at 270 days.

We have previously reported the results of a clinical trial in which the Noveon laser was used to treat onychomycosis. In the 180-day follow-up therein it was noted that positive clinical impact was demonstrable by a clearly measurable decrease in positive fungal culture and a concomitant decrease in positive microscopy with periodic acid-Schiff-stained nail scrapings. Review of 270-day mycological data, which are now available, confirmed that there was further decrease in both measures. Indeed, 38% of the treated population had negative culture and microscopy, qualifying as "mycological cures." These mycological cures occurred in cases categorized as mild, moderate, and even severe disease.

An open-label, three-arm pilot study of the safety and efficacy of topical Microcyn Rx wound care versus oral levofloxacin versus combined therapy for mild diabetic foot infections.

BACKGROUND: This randomized, prospective, multicenter, open-label study was designed to test whether a topical, electrolyzed, superoxidized solution (Microcyn Rx) is a safe and effective treatment for mildly infected diabetic foot ulcers. METHODS: Sixty-seven patients with ulcers were randomized into three groups. Patients with wounds irrigated with Microcyn Rx alone were compared with patients treated with oral levofloxacin plus normal saline wound irrigation and with patients treated with oral levofloxacin plus Microcyn Rx wound irrigation. Patients were evaluated on day 3, at the end of treatment on day 10 (visit 3), and 14 days after completion of therapy for test of cure (visit 4). RESULTS: In the intention-to-treat sample at visit 3, the clinical success rate was higher in the Microcyn Rx alone group (75.0%) than in the saline plus levofloxacin group (57.1%) or in the Microcyn Rx plus levofloxacin group (64.0%). Results at visit 4 were similar. In the clinically evaluable population, the clinical success rate at visit 3 (end of treatment) for patients treated with Microcyn Rx alone was 77.8% versus 61.1% for the levofloxacin group. The clinical success rate at visit 4 (test of cure) for patients treated with Microcyn Rx alone was 93.3% versus 56.3% for levofloxacin plus saline-treated patients. This study was not statistically powered, but the high clinical success rate (93.3%) and the P value (P = .033) suggest that the difference is meaningfully positive for Microcyn Rx-treated patients. CONCLUSIONS: Microcyn Rx is safe and at least as effective as oral levofloxacin for mild diabetic foot infections.

Validation of the American College of Foot and Ankle Surgeons Scoring Scales.

The American College of Foot and Ankle Surgeons (ACFAS) assembled a task force to develop a scoring scale that could be used by the membership and practitioners-at-large. The original publication that introduced the scale focused primarily on use of the scale and provided only brief background on the development of the health measurement instrument. Concerns regarding the validity and reliability of the scale were raised within the professional community, and ACFAS assembled a task force to address these concerns. The purpose of this article is to address the issues raised by reporting the detailed methods used in the development of the ACFAS Scoring Scales. The authors who constitute this task force reviewed the body of work previously conducted and applied standards that serve to evaluate the scoring scale for: 1) validity, 2) reliability, and 3) sensitivity to change. The results showed that a systematic and comprehensive approach was used in the development of the scoring scales, and the task force concluded that the statistical methods and instrument development process for all 4 modules of the scoring scales were conducted in an appropriate manner. Furthermore, modules 1 and 2 have been rigorously assessed and the elements of these modules have been shown to meet standards for validity, reliability, and sensitivity to change.

A retrospective clinical study of 188 consecutive patients to examine the effectiveness of a biologically active cryopreserved human skin allograft (TheraSkin®) on the treatment of diabetic foot ulcers and venous leg ulcers.

A biologically active human skin allograft, currently distributed under the brand name TheraSkin(®), was examined for safety and efficacy in the treatment of venous leg ulcers (VLUs) and diabetic foot ulcers (DFUs). The objective was to determine if TheraSkin could serve as a safe and effective alternative to bioengineered skin substitutes such as Apligraf(®) and Dermagraft(®). The authors conducted a retrospective study of 214 consecutive patients seen at the Inova Wound Center (Mt Vernon, Virginia), with either a DFU or a VLU. After excluding patients who did not meet the study criteria, the final eligible cohort consisted of 188 subjects, with 134 VLUs and 54 DFUs. Multivariate logistic regression was used to evaluate the relationship between baseline wound size and the proportion of healed wounds after 12 and 20 weeks from initial allograft application. The authors found that by the 12th week, DFUs closed 60.38% of the time and VLUs closed 60.77% of the time. After 20 weeks, the number of closed DFUs increased to 74.1% and the number of VLUs increased to 74.6%. The mean wound size in the DFU group was 6.2 cm(2) (±11.8) and 11.8 cm(2) (±22.5) in the VLU group. The mean number of TheraSkin allografts required ranged from 1 to 8, with an average of 2.03 (±1.47) at the 12-week point and an average of 3.23 (±2.77) at the 20-week point. Multivariate logistic regression was used to calculate the odds of wound healing by week 12 and week 20 in each group. The authors also analyzed adverse events and found TheraSkin to be noncontributory to any adverse events, verifying the safety of TheraSkin in this study population. In this study, TheraSkin has been shown to be highly effective for the treatment of both VLUs and DFUs with an acceptable safety profile.