Diabetic foot complications that lead to lower extremity amputations pose a significant challenge to the entire global health system. In this multicentre clinical trial, 26 patients with chronic Wagner one diabetic foot ulcers (DFUs) were treated with a unique human keratin matrix graft applied either weekly or bi-weekly, in addition to standard of care. The hypothesis was that bi-weekly application would be similar to weekly application.
View Article and Find Full Text PDFAs 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).
View Article and Find Full Text PDFBackground: Diabetic foot ulcers (DFUs) pose a significant clinical challenge for providers and patients, and often precede devastating complications such as infection, hospitalization, and amputation. Therefore, advanced treatment options are needed to facilitate the healing of chronic DFUs and improve outcomes in this high-risk population. Cryopreserved viable human amnion membrane allograft (vHAMA) has shown great promise in the treatment of recalcitrant DFUs as a supplement to standard of care (SOC).
View Article and Find Full Text PDFA 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.
View Article and Find Full Text PDFPlast Reconstr Surg Glob Open
October 2022
Unlabelled: Diabetic foot complications are increasingly burdensome for patients, clinicians, and society. Development of innovative therapies to support good quality basic care is a priority among those with an interest in this area. One of these involves scanning and printing tissues to match and conform to a defect (so-called 3D printing).
View Article and Find Full Text PDFBackground: This randomized controlled trial evaluated the safety and effectiveness of weekly and biweekly applications of dehydrated human amnion and chorion allograft (dHACA) plus standard of care compared to standard of care alone on chronic venous leg ulcers.
Methods: This open-label randomized controlled trial included patients with chronic venous leg ulcers at eight wound care centers across the United States. The primary endpoint was the proportion of healed ulcers at 12 weeks.
The incidence and economic burden of diabetic foot ulcers continues to rise throughout the world. In this prospective study, a unique device designed to offload the wound, enhance circulation and monitor patient compliance was evaluated for safety and efficacy. The device provides offloading and intermittent plantar compression to improve the pedal flow of oxygenated blood and support wound healing while recording patient use.
View Article and Find Full Text PDFAmniotic membranes are known to be rich in growth factors, cytokines, and matrix proteins, which can help support wound closure and may improve patient outcomes in foot and ankle surgical interventions. In this Institutional Review Board (IRB) approved clinical study, 21 consecutive patients undergoing lower extremity soft tissue and bone reconstruction surgery received dehydrated human amnion and chorion allograft (dHACA) placed as a covering over the deep layers of the surgical wound during closure. Wound healing complications were assessed and American Orthopaedic Foot and Ankle Society (AOFAS) scores were compiled from over a 1-year follow-up period.
View Article and Find Full Text PDFDiabetic foot ulcers (DFUs) pose a significant risk for infection and limb loss. Advanced wound therapies including human skin allografts have shown promise in resolving these challenging wounds. The primary objective of this randomised, prospective study was to compare the response of 100 subjects with non-healing DFUs of which 50 were treated with a cryopreserved bioactive split thickness skin allograft (BSA) (TheraSkin; Misonix,Inc.
View Article and Find Full Text PDFDiabetic 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.
View Article and Find Full Text PDFThis 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.
View Article and Find Full Text PDFDiabetic 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.
View Article and Find Full Text PDFThe varus ankle and cavus foot pose challenges in surgical correction with regard to total ankle replacement surgery. Etiology of cavus foot type and varus ankle must be evaluated and confirmed. Pes cavus is increased height of the arch with metatarsus adductus and increased calcaneal inclination angle.
View Article and Find Full Text PDFUnlabelled: Biomaterial engineering has produced numerous matrices for use in tissue repair, utilizing various materials and processing methods, which can impact the ability of the products to encourage wound healing. Recently, we observed favorable clinical outcomes, using a novel purified reconstituted bilayer matrix (PRBM; Geistlich Derma-Gide) to treat chronic diabetic foot ulcers.
Methods: Evaluations of the structural and functional characteristics of PRBM in vitro were performed to assess how this biomaterial may affect the favorable clinical results observed by influencing the wound environment and key physiologic mechanisms necessary for the healing process.
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.
View Article and Find Full Text PDFUnlabelled: Venous leg ulcers (VLUs) are often refractory to compression therapy, and their prevalence is increasing. An autologous homologous skin construct (AHSC) that uses the endogenous regenerative capacity of healthy skin has been developed to treat cutaneous defects, with a single application. The ability of AHSC to close VLUs with a single treatment was evaluated in an open-label, single-arm feasibility study to test the hypothesis that AHSC treatment will result in wound closure by providing healthy autologous tissue to the wound bed.
View Article and Find Full Text PDFDiabetic foot ulcers (DFUs) are a growing burden on patients and health care systems that often require multiple treatments of both conventional and advanced modalities to achieve complete wound closure. A novel autologous homologous skin construct (AHSC) has been developed to treat cutaneous defects with a single topical application, by leveraging the endogenous repair capabilities of the patient's healthy skin. The AHSC's ability to close DFUs with a single treatment was evaluated in an open-label, single-arm feasibility study.
View Article and Find Full Text PDFDiabetic foot ulcers (DFUs) have significant clinical impact and carry a substantial economic burden. Patients with DFUs that are refractory to standard wound care are at risk for major complications, including infection and amputation and have an increased risk of mortality. This study evaluated the safety and preliminary efficacy of a novel decellularised purified reconstituted bilayer matrix (PRBM) in treating DFUs.
View Article and Find Full Text PDFUnlabelled: 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.
Introduction: Microvascular tissue serves as the foundation for tissue granulation and remodeling during the wound healing process. Optimal repair of microvascular structure and function is essential for future healing capacity and to minimize tissue breakdown in a newly epithelialized wound.
Objective: This case series of 3 patients with nonhealing diabetic foot ulcers (DFUs) refractory to standard wound care demonstrates the ability of processed microvascular tissue (PMVT) to enable wound closure, increase local perfusion and vascular maturity, and improve overall tissue quality.
Int Wound J
December 2018
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.
View Article and Find Full Text PDFAseptically 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.
View Article and Find Full Text PDFBackground: 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.
View Article and Find Full Text PDFBackground: 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.