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.

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.

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.

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.

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.

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.

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. These wavelengths lack the teratogenic danger presented by ultraviolet light and the photoablation toxic plume associated with pulsed Nd:YAG lasers. METHODS: In this randomized controlled study, treatments followed a predefined protocol and laser parameters and occurred on days 1, 14, 42, and 120. Toes were cultured and evaluated, and measurements were taken from standardized photographs obtained periodically during the 180 day follow-up period. RESULTS: We treated mycologically confirmed onychomycosis in 26 eligible toes (ten mild, seven moderate, and nine severe). All of the patients were followed-up for 180 days. An independent expert panel, blinded regarding treatment versus control, found that at 180 days, 85% of the eligible treated toenails were improved by clear nail linear extent (P = .0015); 65% showed at least 3 mm and 26% showed at least 4 mm of clear nail growth. Of the 16 toes with moderate to severe involvement, ten (63%) improved, as shown by clear nail growth of at least 3 mm (P = .0112). Simultaneous negative culture and periodic acid-Schiff was noted in 30% at 180 days. CONCLUSIONS: These results indicate a role for this laser in the treatment of onychomycosis, regardless of degree of severity. Ease of delivery and the lack of a need to monitor blood chemistry are attractive attributes.

A retrospective analysis of 22 patients treated with percutaneous radiofrequency nerve ablation for prolonged moderate to severe heel pain associated with plantar fasciitis.

UNLABELLED: A retrospective study involving 22 patients (31 feet) with a history of prolonged moderate to severe heel pain associated with plantar fasciitis were examined to determine if ablation of the sensory branch of the medial calcaneal nerve would result in symptomatic relief. Participants in this study were given subjective questionnaires and visual analog scales in order to rate their symptoms before and after nerve ablation using radiofrequency energy. The results showed that the mean preintervention visual analog pain score was 8.12 +/- 1.61 (with 10 being the worst pain the patient could imagine), and this dropped to 3.26 +/- 1.97 after 1 week and 1.46 +/- 1.76 after 1 month, 1.96 +/- 1.98 at 3 months, and 2.07 +/- 2.06 at 6 months, and the improvement was statistically significant (P < .001) at each stage of follow-up. Furthermore, patients followed for up to 1 year showed no significant worsening of symptoms. Adverse events were limited to hematoma at the site of entry of the radiofrequency cannula. These findings support the conclusion that radiofrequency nerve ablation be considered an alternative to repetitive corticosteroid injections or open surgical intervention for the treatment of recalcitrant plantar heel pain. LEVEL OF CLINICAL EVIDENCE: 4.

Intermittent pressure decreases human keratinocyte proliferation in vitro.

BACKGROUND: The aim of this study was to investigate the correlation between pressure changes and keratinocyte proliferation by determining whether keratinocytes exposed to altered mechanical pressures would proliferate at different rates compared to control cells not subjected to pressure changes. METHODS: Tissue culture flasks of human keratinocytes plated at an approximate density of 15,000 cells/cm(2) undergoing an intermittent cyclic pressure of 362 mm Hg at a frequency of 2.28 or 5.16 cycles/min (0.038 or 0.086 Hz) for 8 h were compared to control flasks grown at ambient room pressure. An in-line pressure transducer was used to monitor and adjust pressure within the cell chambers, using a solenoid valve. A thymidine incorporation assay assessed the amount of cell proliferation in each set of experiments. RESULTS: Differences in proliferation between keratinocytes subjected to cyclic pressure changes and control cells were found to be statistically significant (p < 0.05) in 4 out of 5 proliferation assays. Also, a higher frequency of pressure changes consistently generated a reduced proliferation rate compared to that seen in cells exposed to a lower frequency of pressure changes. CONCLUSION: These data indicate that keratinocytes undergoing intermittent pressure changes exhibit decreased proliferation rates compared to controls. Furthermore, an increased frequency rate seems to have a greater effect on proliferation than low-frequency rate pressure changes, suggesting that the stress caused by frequently changed pressure may play a greater role in reducing keratinocyte proliferation than the actual magnitude of load applied to the cells. Our results support the current treatment protocol of reducing speed and duration of walking on the site of the wound to promote healing of foot ulcers.

A retrospective assessment of partial calcanectomies and factors influencing postoperative course.

Partial calcanectomies are a common procedure for the treatment of chronic heel ulcers. We reviewed 50 cases from patients who had partial calcanectomies to determine what factors, if any, affect the rate of healing. Each case was followed up for 1 to 6 years after surgery. We found that calcanectomy wounds were difficult to heal, regardless of the etiology. We examined a multitude of factors to determine which ones affected the rate of closure, including body mass index, vascular status, preoperative albumin levels, wound grade, presence of methacillin-resistant Staphylococcus aureus, and other factors. We found that the average total closure rate for patients undergoing partial calcanectomy was between 51% and 83% after 1 year, depending on various preoperative conditions. Our data suggest that even though the procedure itself is fairly straightforward, the course of recovery is complex, with a fairly high rate of failure after 1 year. We found that preoperative infections with methacillin-resistant Staphylococcus aureus, vascular disease, albumin levels, and preoperative ulcer grade had a significant bearing on the outcomes. We also identified other factors that did not seem to affect surgical outcomes. Based on these findings, the authors suggest some factors that should be considered when performing partial calcanectomies.

Diabetic foot disorders. A clinical practice guideline (2006 revision).

The prevalence of diabetes mellitus is growing at epidemic proportions in the United States and worldwide. Most alarming is the steady increase in type 2 diabetes, especially among young and obese people. An estimated 7% of the US population has diabetes, and because of the increased longevity of this population, diabetes-associated complications are expected to rise in prevalence. Foot ulcerations, infections, Charcot neuroarthropathy, and peripheral arterial disease frequently result in gangrene and lower limb amputation. Consequently, foot disorders are leading causes of hospitalization for persons with diabetes and account for billion-dollar expenditures annually in the US. Although not all foot complications can be prevented, dramatic reductions in frequency have been achieved by taking a multidisciplinary approach to patient management. Using this concept, the authors present a clinical practice guideline for diabetic foot disorders based on currently available evidence, committee consensus, and current clinical practice. The pathophysiology and treatment of diabetic foot ulcers, infections, and the diabetic Charcot foot are reviewed. While these guidelines cannot and should not dictate the care of all affected patients, they provide evidence-based guidance for general patterns of practice. If these concepts are embraced and incorporated into patient management protocols, a major reduction in diabetic limb amputations is certainly an attainable goal.

Plantar forefoot pressure changes after second metatarsal neck osteotomy.

BACKGROUND: The aim of this study was to evaluate plantar pressure changes after second metatarsal neck osteotomy using the Weil technique. METHODS: Six below-knee cadaver specimens were used. Each specimen was held in a custom-built apparatus and loaded to 500 N for a period of 3 seconds. Using a computerized Musgrave pedobarograph, pressure measurements were made before and after osteotomy in both neutral and 45-degree heel rise positions. All osteotomies were made at an angle of approximately 20 degrees relative to the long axis of the metatarsal shaft. The metatarsal heads were displaced proximally by 5 mm and fixed with a single Kirschner wire. RESULTS: After osteotomy there was an average decrease in pressure beneath the second metatarsal from 70.6 to 45.1 kPa in neutral and from 813.0 to 281.4 kPa in heel rise, representing statistically significant (p < or = 0.05) decreases of 36% and 65%, respectively. There also were significant decreases beneath the third metatarsal in both neutral (39%) and heel rise (37%), and beneath the fourth metatarsal in neutral position (28%). A significant pressure increase occurred beneath the first metatarsal in neutral (23%). No significant pressure changes occurred under the fifth metatarsal in either position. CONCLUSION: Overall, our results indicated that the Weil metatarsal neck osteotomy is effective at offloading the second metatarsal head at neutral and heel rise positions.

A simple technique for correcting footdrop: suspension tenodesis of the tibialis anterior tendon to the distal tibia.

Surgical correction of the footdrop deformity caused by various neuromuscular diseases is a time-honored technique, with most surgical procedures intended to correct the absence of active dorsiflexion and a concomitant cavovarus foot deformity. We describe suspension tenodesis of the tibialis anterior tendon to the distal tibia to correct the footdrop deformity. This technique is simpler to perform and more secure than transferring the distal attachment of a tendon to a new location in the foot itself or using tendon weaving techniques. In addition, compared with an ankle fusion, our technique allows for a certain amount of shock absorption during gait and is much less invasive, and a future ankle fusion could be performed if needed for full stability and definitive correction of the symptomatic footdrop. Finally, the technique we describe is easily reproducible and seems to remain stable over time.

Predicting articular erosion in hallux valgus: clinical, radiographic, and intraoperative analysis.

The authors present a prospective intraoperative evaluation of the articular wear pattern of the first metatarsal, tibial and fibular sesamoids, and base of the proximal phalanx of 166 feet undergoing hallux valgus surgery. The collected data were compared with various clinical parameters and radiographic measurements to determine if any of these variables can predict the incidence and location of articular erosion. The incidence and predictability of the location of the articular erosion increased significantly as the patient's age ( P = .000), intermetatarsal angle 1-2 ( P = .004), hallux abductus angle ( P = .000), tibial sesamoid position ( P = .016), and proximal articular set angle ( P = .02) increased. The association of foot type (ie, digital length pattern), metatarsal protrusion distance, metatarsal head shape, and hallux abductus interphalangeus was not significant. Therefore, preoperative clinical parameters (ie, age) and radiographic measurements (ie, intermetatarsal angle 1-2, hallux abductus angle, tibial sesamoid position, and proximal articular set angle) can directly define the incidence and location of articular erosion and are helpful in the preoperative assessment of the hallux valgus deformity. In addition, nearly every first metatarsophalangeal joint evaluated had some degree of articular erosion and, in certain circumstances (ie, advanced age and increased proximal articular set angle), it was universal and extensive.

Reconstruction of the great toe ski-slope, sunken-nail deformity with a buried adipofascial flap.

Development of a ski-slope deformity following loss of the great toe nail plate is a problematic condition with few conservative or surgical options available. The condition becomes more difficult to treat when the distal, medial, and lateral labial nail folds are hypertrophied, creating the appearance of a sunken nail. We present a case of ski-slope, sunken-nail deformity following multiple attempts at chemical nail matrixectomy. The patient's persistent pain and deformity were managed through 1) nail plate avulsion and complete surgical excision of the germinal nail matrix, 2) remodeling of the distal phalanx, and 3) elevation of an adipofascial flap from the plantar tuft of the great toe, which was brought from plantar to dorsal and interposed between the dorsal aspect of the distal phalanx and the overlying nail bed in buried fashion. The combination of these procedures elevated the nail bed, which restored normal architecture to the great toe and relieved the pain associated with the chronic deformity. This case demonstrates a potential complication of a commonly performed procedure and a salvage technique useful for dealing with the resultant ski-slope, sunken-nail deformity.