To evaluate the status of a 7-month phase 3 study conducted to test the effect of intramuscular injections of VM202 (ENGENSIS), a plasmid DNA encoding human hepatocyte growth factor, into the calf muscles of chronic nonhealing diabetic foot ulcers with concomitant peripheral artery disease. The phase 3 study, originally aimed to recruit 300 subjects, was discontinued because of slow patient recruitment. An unprespecified interim analysis was performed for the 44 subjects enrolled to assess the status and determine the future direction.
View Article and Find Full Text PDFThere are many factors to consider when treating an Achilles tendon rupture in the acute and chronic/neglected settings. For acute rupture, operative and nonoperative management contribute to a good prognosis with low associated risks. Patient or injury characteristics can assist in the shared decision-making about treatment.
View Article and Find Full Text PDFChronic nonhealing heel ulcerations have been established as an independent risk factor for major amputation, with poor rates of limb salvage success. Partial calcanectomy is a controversial limb salvage procedure reserved for patients with these heel ulcerations. We conducted a retrospective cohort study reviewing 39 limbs that underwent a partial calcanectomy from 2012 to 2018 to evaluate the proportion of patients healed, time to healing, ulcer recurrence, and postoperative functional level compared to the preoperative state.
View Article and Find Full Text PDFIntroduction: Cryopreserved placental membrane containing viable cells (vCPM) in conjunction with standard of care (SOC) has shown clinical effectiveness in several studies for the management of acute and chronic wounds. Recently, a new lyophilization technique has been developed that allows viable tissues to be stored at room temperature as a structural and functional equivalent to vCPM.
Objective: This case series evaluates the clinical outcomes of a lyopreserved placental membrane containing viable cells (vLPM) for the management of chronic wounds of various etiologies.
In 2012 we reported promising results from a phase 2 clinical trial of HP802-247, a novel spray-applied investigational treatment for chronic venous leg ulcers consisting of human, allogeneic fibroblasts and keratinocytes. We now describe phase 3 clinical testing of HP802-247, its failure to detect efficacy, and subsequent investigation into the root causes of the failure. Two randomized, controlled trials enrolled a total of 673 adult outpatients at 96 centers in North America and Europe.
View Article and Find Full Text PDFOsteomyelitis is one of the most feared sequelae of diabetic foot ulceration, which often leads to lower-extremity amputation and disability. Early diagnosis of osteomyelitis increases the likelihood of successful treatment and may limit the amount of bone resected, preserving ambulatory function. Although a variety of techniques exist for imaging the diabetic foot, standard radiography is still the only in-office imaging modality used today.
View Article and Find Full Text PDFBackground: Chronic venous leg ulcers (VLUs) can be challenging to manage and heal. Despite the observed efficacy of surgical debridement, many patients with VLUs refuse the procedure due to the associated pain. Autolytic debridement induces no pain, but is slow or disrupted in chronic VLUs.
View Article and Find Full Text PDFClin Podiatr Med Surg
July 2012
Subtalar joint arthroereisis is a surgical procedure that addresses symptomatic flexible flatfoot deformities using an extraarticular implant within the sinus tarsi. Three groups of implants have been developed for this procedure: self-locking wedges, axis-altering devices, and impact-blocking devices. The self-locking wedge implants are the focus of this article, relative to its use, limitations, and controversies in the pediatric and adult population.
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