A purified reconstituted bilayer matrix shows improved outcomes in treatment of non-healing diabetic foot ulcers when compared to the standard of care: Final results and analysis of a prospective, randomized, controlled, multi-centre clinical trial.

As the incidence of diabetic foot ulcers (DFU) increases, better treatments that improve healing should reduce complications of these ulcers including infections and amputations. We conducted a randomized controlled trial comparing outcomes between a novel purified reconstituted bilayer membrane (PRBM) to the standard of care (SOC) in the treatment of non-healing DFUs. This study included 105 patients who were randomized to either of two treatment groups (n = 54 PRBM; n = 51 SOC) in the intent to treat (ITT) group and 80 who completed the study per protocol (PP) (n = 47 PRBM; n = 33 SOC).

A multicenter, randomized controlled clinical trial evaluating the effects of a novel autologous heterogeneous skin construct in the treatment of Wagner one diabetic foot ulcers: Final analysis.

A novel autologous heterogeneous skin construct (AHSC) was previously shown to be effective versus standard of care (SOC) treatment in facilitating complete wound healing of Wagner 1 diabetic foot ulcers in an interim analysis of 50 patients previously published. We now report the final analysis of 100 patients (50 per group), which further supports the interim analysis findings. Forty-five subjects in the AHSC treatment group received only one application of the autologous heterogeneous skin construct, and five received two applications.

The Role of Arthroscopy After Total Ankle Replacement.

Alongside advances and trends in foot and ankle surgery, arthroscopy provides a minimally invasive option in exploring and addressing pain after total ankle replacement (TAR). It is not uncommon for patients to develop pain months or even years after TAR implantation for both fixed and mobile-bearing designs. Arthroscopic debridement of gutter pain can provide successful outcomes in the hands of the experienced arthroscopist.

Exploring the Relationship Between Clinical Presentation in Hallux Valgus and Response to AbobotulinumtoxinA Treatment.

The relationship between pain/disability and angular deviation of the hallux valgus (HV), and the impact of orthotic use, laterality, and pain variability on treatment outcomes remain unclear. This was explored in post hoc analyses of a placebo-controlled trial of abobotulinumtoxinA (aboBoNT-A; Dysport®) for HV-associated pain (NCT03569098). The primary endpoint was not met in this study (change from baseline Numeric Pain Rating Scale [NPRS] score vs placebo at week 8); however, there was a greater reduction from baseline in mean NPRS score at week 12 with aboBoNT-A 500U versus placebo (p = .

Pain Reduction With AbobotulinumtoxinA for the Treatment of Hallux Valgus in Adult Participants: Results of a Randomized and Placebo-Controlled Phase 2 Trial.

AbobotulinumtoxinA (aboBoNT-A, Dysport® [Ipsen, Paris, France]) inhibits acetylcholine release at the neuromuscular junction and may modulate pain signaling in hallux valgus (HV). This randomized study (NCT03569098) included a double-blind phase (aboBoNT-A 300U, 500U or placebo injections into forefoot muscles) and an open-label aboBoNT-A treatment period in participants with an HV diagnosis and no HV surgery. The primary endpoint was change from baseline in numeric pain rating scale (NPRS) score at week 8.

Time to Revision After Periprosthetic Joint Infection in Total Ankle Arthroplasty: A Systematic Review.

While not a common complication after total ankle arthroplasty (TAA), periprosthetic joint infection (PJI) presents a significant risk of implant failure. The primary aim of this systematic review was to evaluate time to revision after PJI in patients who had undergone TAA. An extensive search strategy via electronic databases initially captured 11,608 citations that were evaluated for relevance.

Plate Fixation in Midfoot and Ankle Charcot Neuroarthropathy.

Surgical reconstruction of Charcot arthropathy in the foot and ankle is extremely difficult. The fundamentals of reconstruction are necessary to provide adequate outcome. Removing and resecting the diseased bone is needed along with good anatomic alignment and rigid fixation.

Use of a purified reconstituted bilayer matrix in the management of chronic diabetic foot ulcers improves patient outcomes vs standard of care: Results of a prospective randomised controlled multi-centre clinical trial.

Diabetic foot infections continue to be a major challenge for health care delivery systems. Following encouraging results from a pilot study using a novel purified reconstituted bilayer matrix (PRBM) to treat chronic diabetic foot ulcers (DFUs), we designed a prospective, multi-centre randomised trial comparing outcomes of PRBM at 12 weeks compared with a standard of care (SOC) using a collagen alginate dressing. The primary endpoint was percentage of wounds closed after 12 weeks.

Improved healing of chronic diabetic foot wounds in a prospective randomised controlled multi-centre clinical trial with a microvascular tissue allograft.

This study assesses the impact of a processed microvascular tissue (PMVT) allograft on wound closure and healing in a prospective, single-blinded, multi-centre, randomised controlled clinical trial of 100 subjects with Wagner Grade 1 and 2 chronic neuropathic diabetic foot ulcerations. In addition to standard wound care, including standardised offloading, the treatment arm received PMVT while the control arm received a collagen alginate dressing. The primary endpoint was complete wound closure at 12 weeks.

A multi-centre, single-blinded randomised controlled clinical trial evaluating the effect of resorbable glass fibre matrix in the treatment of diabetic foot ulcers.

Diabetic foot ulcers (DFUs) are at risk for detrimental complications even with current, standard of care (SOC) treatments. The primary objective of this randomised controlled trial was to compare a unique resorbable glass microfiber matrix (Mirragen; Advanced Wound Matrix [BBGFM]; ETS Wound Care, Rolla, Missouri) compared with a standard of care group (SOC, collagen alginate dressing) at 12 weeks. Both groups received standard diabetic foot care including glucose monitoring, weekly debridements when needed and an offloading device.

The Cavovarus Ankle: Approaches to Ankle Instability and Inframalleolar Deformity.

Pathologic affects from a cavus foot deformity range from flexible subtle to rigid severe deformities and are related to many pathologic conditions of the foot and ankle. Understanding the underlying deformity and the deforming force is essential in treating the cavus ankle and foot. Every deformity is different and unique to a given patient; therefore, surgical plans should be modified to each patient.

Hallux and Lesser Digits Deformities Associated with Cavus Foot.

It is important to identify the level of the deformity or deformities. It is important to get the limb as close to anatomic alignment as possible. Many levels and multiple procedures may be involved with this reconstruction.

A multicentre, randomised controlled clinical trial evaluating the effects of a novel autologous, heterogeneous skin construct in the treatment of Wagner one diabetic foot ulcers: Interim analysis.

We desired to carefully evaluate a novel autologous heterogeneous skin construct in a prospective randomised clinical trial comparing this to a standard-of-care treatment in diabetic foot ulcers (DFUs). This study reports the interim analysis after the first half of the subjects have been analysed. Fifty patients (25 per group) with Wagner 1 ulcers were enrolled at 13 wound centres in the United States.

Woringer-Kolopp Disease of the Foot: A Case Report.

Woringer-Kolopp disease is a rare variant of mycosis fungoides, a type of cutaneous T-cell lymphoma. Described is a case of a small annular plaque on the foot diagnosed histologically as Woringer-Kolopp disease and treated successfully with topical and intralesional steroids. In addition, a brief review of the literature and treatment options is provided.

Placental Membrane Provides Improved Healing Efficacy and Lower Cost Versus a Tissue-Engineered Human Skin in the Treatment of Diabetic Foot Ulcerations.

Unlabelled: Aseptically processed dehydrated human amnion and chorion allograft (dHACA) (AmnioBand) has shown great promise in the treatment of recalcitrant diabetic foot ulcers (DFUs) when compared with standard wound care but has not yet been compared to any other tissue forms used in treating DFUs. The hypothesis was to conduct a randomized controlled trial in which dHACA was compared to one of the earliest and most commonly accepted tissue-engineered skin substitutes (TESS) (Apligraf) in the treatment of nonhealing DFUs over a period of 12 weeks to assess the superiority of healing.

Methods: Following a 2-week screening period during which subjects with DFUs were treated with collagen alginate dressing, 60 subjects were randomized at 5 sites to receive either dHACA or TESS applied weekly, with weekly follow-up for up to 12 weeks.

Calcaneal Bone Graft Procedures: An Analysis of Postsurgical Complications.

The purpose of this article is to examine complications in patients who underwent bone grafting from the calcaneus between December 2001 and June 2010. This retrospective, single-practice study included 247 procedures in 242 patients, including 200 (82.64%) female and 42 (17.

Use of an aseptically processed, dehydrated human amnion and chorion membrane improves likelihood and rate of healing in chronic diabetic foot ulcers: A prospective, randomised, multi-centre clinical trial in 80 patients.

Amnion and chorion allografts have shown great promise in healing diabetic foot ulcers (DFUs). Results from an interim analysis of 40 patients have demonstrated the accelerated healing ability of a novel aseptically processed, dehydrated human amnion and chorion allograft (dHACA). The goal of this study was to report on the full trial results of 80 patients where dHACA was compared with standard of care (SOC) in achieving wound closure in non-healing DFUs.

An aseptically processed, acellular, reticular, allogenic human dermis improves healing in diabetic foot ulcers: A prospective, randomised, controlled, multicentre follow-up trial.

Aseptically processed human reticular acellular dermal matrix (HR-ADM) has been previously shown to improve wound closure in 40 diabetic patients with non-healing foot ulcers. The study was extended to 40 additional patients (80 in total) to validate and extend the original findings. The entire cohort of 80 patients underwent appropriate offloading and standard of care (SOC) during a 2-week screening period and, after meeting eligibility criteria, were randomised to receive weekly applications of HR-ADM plus SOC or SOC alone for up to 12 weeks.

Treating Charcot Arthropathy Is a Challenge: Explaining Why My Treatment Algorithm Has Changed.

Charcot deformity is a challenge that foot and ankle surgeons struggle to manage successfully. Despite the advances in knowledge, technology, and treatment modalities, limb loss is still greater than 10%. This article discusses the efficacy of conservative measures and traditional surgical approaches.

Wound Care Centers: Critical Thinking and Treatment Strategies for Wounds.

Many wound care centers (WCCs) provide a specialized level of care using various wound care therapies and are managed by quali ed healthcare professionals (QHPs) from di erent specialty backgrounds such as family medicine, podiatry, and plastic surgery. However, these QHPs are sometimes challenged by reimbursement issues, limited therapy and dressing options, reduced access to multidisciplinary team members, and cost-driven factors unique to WCCs. To help address these issues, a meeting was convened by an expert panel of WCC physicians to discuss best practices for treating complex patients in a WCC.

Subtalar Joint Arthrodesis for Elective and Posttraumatic Foot and Ankle Deformities.

Subtalar joint arthrodesis is a procedure used in posttraumatic arthritis, osteoarthritis, tarsal coalition management, posterior tibial tendon dysfunction, and inflammatory arthropathies, and can be used in deformity correction. The goals of the procedure are to eliminate pain, improve function, restore stability, and realign the hind foot. The procedure has high patient satisfaction with low complications while preserving motion in adjacent tarsal joints.

Human Reticular Acellular Dermal Matrix in the Healing of Chronic Diabetic Foot Ulcerations that Failed Standard Conservative Treatment: A Retrospective Crossover Study.

Background: Acellular matrices have been successfully used to heal indolent diabetic foot ulcers (DFUs). These tissues include allogenic dermis as well as xenograft dermis, pericardium, and small intestine submucosa. While all of these tissues show promise for healing DFUs, dermal-derived matrices have shown considerable potential.

Aseptically Processed Placental Membrane Improves Healing of Diabetic Foot Ulcerations: Prospective, Randomized Clinical Trial.

Background: Allogeneic grafts derived from amnion/chorion are known to be efficacious in healing chronic diabetic foot ulcerations (DFUs). The goal of this study was to compare aseptically processed dehydrated human amnion and chorion allograft (dHACA) versus standard of care (SOC) in facilitating wound closure in nonhealing DFUs.

Methods: Patients with DFUs treated with SOC (off-loading, appropriate debridement, and moist wound care) after a 2-week screening period were randomized to either SOC or wound-size-specific dHACA (AmnioBand, Musculoskeletal Transplant Foundation, Edison, N.

A prospective, randomised, controlled, multicentre clinical trial examining healing rates, safety and cost to closure of an acellular reticular allogenic human dermis versus standard of care in the treatment of chronic diabetic foot ulcers.

Acellular dermal matrices can successfully heal wounds. This study's goal was to compare clinical outcomes of a novel, open-structure human reticular acellular dermis matrix (HR-ADM) to facilitate wound closure in non-healing diabetic foot ulcers (DFUs) versus DFUs treated with standard of care (SOC). Following a 2-week screening period in which DFUs were treated with offloading and moist wound care, patients were randomised to either SOC alone or HR-ADM plus SOC applied weekly for up to 12 weeks.