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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

A prospective comparison of diabetic foot ulcers treated with either a cryopreserved skin allograft or a bioengineered skin substitute.

Unlabelled: Background. It was hypothesized that the rate of wound closure and the number of grafts required will be the same when treating diabetic foot ulcers with TheraSkin®, a cryopreserved split-thickness skin allograft (SSA), as compared to Apligraft®, a bioengineered skin substitute (BSS).

Methods: A prospective study using sequentially enrolled patients seen in a large podiatric practice encompassing multiple locations was conducted.

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.

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.

Analysis of the SNaP Wound Care System, a negative pressure wound device for treatment of diabetic lower extremity wounds.

Negative pressure wound therapy (NPWT) has become a widely used modality for the treatment of complex wounds. However, patient compliance is frequently difficult due to the need to carry a bulky, noisy electronic device. In this issue of Journal of Diabetes Science and Technology, Lerman and colleagues describe a new system that uses no electricity and is about the size of a deck of cards.

Treatment of mild, moderate, and severe onychomycosis using 870- and 930-nm light exposure.

Background: The Noveon is a unique dual-wavelength near-infrared diode laser used to treat onychomycosis. The device operates at physiologic temperatures that are thermally safe for human tissue. It uses only 870- and 930-nm near-infrared light, wavelengths that have unique photolethal effects on fungal pathogens.

Diabetic foot ulcers treated with becaplermin and TheraGauze, a moisture-controlling smart dressing: a randomized, multicenter, prospective analysis.

Background: It is hypothesized that moisture regulation specific to the area of contact results in local wound conditions more amenable to healing, which would result in faster and more frequent wound closure. TheraGauze is a new polymer-impregnated dressing designed to regulate moisture to a varying degree over the entire surface of a wound.

Methods: This prospective, randomized, multicenter study examined outcomes from treatment of diabetic foot ulcers with TheraGauze and TheraGauze in conjunction with becaplermin.