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.

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.

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.

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 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. Patients were sequentially enrolled and treated with either BSS or SSA. All other factors of treatment were standardized across the patient population. Data analysis included an analysis of co-factors in each group in order to determine if anything else may have influenced the outcomes. RESULTS: Data from 17 wounds (16 patients) treated with BSS and 12 wounds treated with SSA were analyzed. The average wound sizes were comparable, as was the average number of applications utilized. These data revealed that 41.3% of the wounds treated with BSS closed within 12 weeks, as compared to 66.7% of the wounds treated with SSA. At 20 weeks, 47.1% of the wounds in the BSS group closed, while 66.7% of the SSA wounds closed. There were a comparable number of adverse events in each group, with none that were a direct result of the biologic material being used. CONCLUSION: SSA resulted in a higher percentage of wounds closing after 12 and 20 weeks, as compared to wounds treated with BSS. There were no adverse events noted that were directly related to either graft material.

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.

Scientific assessment of over-the-counter foot orthoses to determine their effects on pain, balance, and foot deformities.

BACKGROUND: A scientific study was conducted to evaluate the effects of non-custom-molded (over-the-counter) foot orthoses. METHODS: Several parameters were examined, including foot, knee, hip, and back pain; balance; and reduction in flexible deformities, such as hammer toes and hallux valgus. Wherever possible, objective measurements were used, including measurements of shifts in center of pressure to assess balance and changes in bone position examined on radiographs. Forty-one individuals were analyzed using one of two types of prefabricated, non-custom insoles. Insoles were fit by an assistant trained to follow the fitting recommendations of the manufacturer under the direct supervision of a podiatric physician. RESULTS: Use of these arch supports resulted in a significant reduction in some types of foot pain associated with hallux valgus (P = .04) and pain in the arch area (P = .004), knee (P = .002), and back (P = .007) by week 4. We also measured changes in foot position documented by radiography, although some changes may be attributed to parallax associated with measurement techniques. Improvement in balance was not observed to be significant when the orthoses were worn. CONCLUSIONS: Using both subjective and objective measures, we found that these over-the-counter foot orthoses were effective in bringing about changes in foot shape and concomitant relief of certain specific painful conditions. This study indicates that there is a scientific basis for attempting to relieve pain with orthoses.

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.

Thermal properties of first metatarsal osteotomies.

UNLABELLED: Heat is generated whenever osteotomies are created, Kirschner wires are inserted, holes are drilled, and when bone is reduced with a burr. Although previous investigators have determined the combination of time and temperature necessary to cause bone injury, to our knowledge, no one has yet specifically studied whether the heat generated when osteotomies are performed in the foot reaches sufficient levels to damage osseous tissue. Toward that end, the authors designed an experiment to measure the change in cadaveric first metatarsal temperature, and the time associated with the rise and fall of the bone temperature, in response to osteotomies performed with and without concomitant saline solution irrigation of the saw blade. The study was conducted on matched pairs (contralateral limbs) of cadaveric bone, with one side being irrigated with normal saline solution and the other side being osteotomized without saline solution irrigation. Osteotomies were created dorsally and plantarly at 3 sites in the first metatarsal specimens, specifically at the head, mid-diaphysis, and base; and a total of 112 osteotomies were included in the analyses. Regardless of whether saline solution irrigation was used, none of the bone specimens reached a temperature known to be associated with thermal injury during osteotomy. The use of saline solution irrigation did, however, provide a reduction in peak bone temperature during osteotomy, and the duration of sustained temperature elevation was also shortened with the use of irrigation. LEVEL OF CLINICAL EVIDENCE: 5.

Meta-analysis of first metatarsophalangeal joint implant arthroplasty.

UNLABELLED: Management of late-stage degenerative joint disease of the first metatarsophalangeal joint (MPJ) is a complex topic that is frequently the source of debate among foot and ankle surgeons. Several surgical interventions have been described to treat this condition. One of the most contested of these treatments is implant arthroplasty of the first MPJ. The primary aim of this meta-analysis was to evaluate the clinical benefit of first MPJ implant arthroplasty in regard to patient satisfaction. Reviewers formally trained in meta-analysis abstraction techniques searched databases and indices using medical subject heading terms and other methods to identify all relevant studies published since 1990. Initially, 3874 citations were identified and evaluated for relevance. Abstract screening produced 112 articles to be read in entirety, of which 47 articles studying 3049 procedures with a mean 61.48 (SD 45.03) month follow-up met all prospective inclusion criteria necessary for analysis. Overall crude patient satisfaction following first MPJ implant arthroplasty was 85.7% (95% confidence interval: 82.5%-88.3%). When adjusting for lower quality studies (retrospective, less than 5 years of follow-up, higher percent of patients lost to follow-up), the overall patient satisfaction increased to 94.5% (89.6%-97.2%) in the highest-quality studies. This adjustment also significantly decreased heterogeneity across studies (crude Q = 184.6, high-quality studies Q = 2.053). Additional a priori sources of heterogeneity were evaluated by subgroup analysis and meta-regression. In regards to patient satisfaction, this comprehensive analysis provides supportive evidence to the clinical benefit of first MPJ implant arthroplasties. LEVEL OF CLINICAL EVIDENCE: 1.

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.

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.

Living cells or collagen matrix: which is more beneficial in the treatment of diabetic foot ulcers?

In a randomized multicenter study, 26 subjects with diabetes, neuropathy, and foot ulceration were treated with standard local wound care and application of either a living skin equivalent [LSE] (Dermagraft®, Advanced BioHealing, La Jolla, Calif) or extracellular matrix [ECM] collagen wound dressing (OASIS® Wound Matrix, Healthpoint, Fort Worth, Tex). Subjects were analyzed to confirm that the wounds, demographics, and health characteristics of subjects in each group were equivalent. Depending on the randomization, subjects received up to 3 applications of LSE or 8 applications of ECM. Subjects received this treatment in conjunction with standard saline dressings for a maximum of 12 weeks, and were observed for 20 weeks. No statistically significant difference was found in the size, distribution, or characteristics of the wounds evaluated in each group. There was no statistically significant difference in the time to closure or the rate of closure between the two groups. Similarly, no significant adverse events were reported in either group. The results of this study show comparable healing rates with use of either material. Further, it was hypothesized that both collagen and cellular components are necessary, and it is suggested that various conditions may make one or the other material more desirable.

Tenotomy and tendon transfer about the forefoot, midfoot and hindfoot.

Tendon lengthening and transfer are essential surgical procedures for every foot and ankle surgeon to master, because they are useful in restoring balance and correcting flexible foot deformities. These techniques are even more useful in treating the high-risk patient, because they involve minimal soft-tissue injury and maximum preservation of vascularity. The primary goal of this article is to supplement the foot and ankle surgeon's options for treating static and dynamic foot deformities in the high-risk patient by discussing useful tendon lengthening and transfer procedures about the forefoot, midfoot, and hindfoot.

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.

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.