A Phase 2a Multi-Center, Prospective, Randomized Controlled Study to Evaluate the Safety and Efficacy of Topically Applied PEP-TISSEEL in Subjects With Diabetic Foot Ulcers (DFU)

A Phase 2a Multi-Center, Prospective, Randomized, Controlled Study to Evaluate the Safety and Efficacy of Topically Applied PEP-TISSEEL in Subjects with Diabetic Foot Ulcers (DFU)

开始日期2024-02-27

申办/合作机构

Rion, Inc.

[+1]

NCT06140303 / Not yet recruiting临床3期

Multi-Center, Prospective, Randomized Controlled Trial Evaluating SkinTE® for the Treatment of Wagner 1 Diabetic Foot Ulcers. Closure Obtained With Vascularized Epithelial Regeneration for DFUs With SkinTE® II (COVER DFUS II)

The purpose of this study is to assess the safety and efficacy of SkinTE for treatment of Wagner grade 1 diabetic foot ulcers.

开始日期2024-02-01

申办/合作机构

RegenETP, Inc.

[+1]

NCT06035536 / RecruitingN/A

A Multi-Center, Randomized Controlled Clinical Investigation Evaluating Wound Closure With Symphony™ Versus Standard of Care in the Treatment of Non-Healing Diabetic Foot Ulcers

The study will evaluate the safety and performance of Symphony™ versus Standard of Care (SOC) in the treatment of chronic non-healing diabetic foot ulcers (DFU) after 12 weeks of treatment.

开始日期2023-06-08

申办/合作机构

Aroa Biosurgery Ltd.

[+1]

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2023-12-01·International Wound Journal

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

Article

作者: Snyder, Robert ; Swanson, Edward W ; Sopko, Nikolai A ; Armstrong, David G ; Didomenico, Lawrence ; Glat, Paul M ; Zelen, Charles M ; Galiano, Robert ; Orgill, Dennis P ; Sigal, Felix ; Li, William W ; Carter, Marissa

AbstractA 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. For the primary endpoint at 12 weeks, there were significantly more diabetic wounds closed in the AHSC treatment group (35/50, 70%) than in the SOC control group (17/50, 34%) (p = 0.00032). A significant difference in percentage area reduction between groups was also demonstrated over 8 weeks (p = 0.009). Forty‐nine subjects experienced 148 adverse events: 66 occurred in 21 subjects (42%) in the AHSC treatment group versus 82 in 28 SOC control group subjects (56.0%). Eight subjects were withdrawn due to serious adverse events. Autologous heterogeneous skin construct was shown to be an effective adjunctive therapy for healing Wagner 1 diabetic foot ulcers.

2021-07-01·Clinics in Podiatric Medicine and Surgery4区 · 医学

Consideration for Total Ankle Replacement in the Varus Ankle and Cavovarus Foot Type

4区 · 医学

Review

作者: Tacktill, Jordan ; Savasky, Benjamin ; Rasor, Zachary ; Zelen, Charles M

The 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. There often is intrinsic musculature irregularity leading to imbalance of the foot. Although not all cavus foot types and varus ankle deformities are sequelae of neuromuscular disorder, neurologic etiology must be considered. Attaining neutral alignment of ankle joint articular surface is paramount to longevity and functionality of ankle joint replacement implant.

2019-04-01·Wounds : a compendium of clinical research and practice4区 · 医学

Clinical Achievement of Wound Closure and Tissue Quality With a Novel Microvascular Tissue Graft.

4区 · 医学

Article

作者: Li, William W ; Gould, Lisa J ; Zelen, Charles M

INTRODUCTIONMicrovascular 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.OBJECTIVEThis 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.MATERIALS AND METHODSThree patients with nonhealing DFUs ranging from 1.1 cm2 to 11.2 cm2 recalcitrant to standard of care were treated weekly with topical PMVT and standard of care. Wound closure was measured weekly using infrared imaging. Fluorescence microangiography was used to perform dynamic quantification of wound microcirculation and assess the perfusion quality. Ingress rates were measured at 5 defined rectangular regions of interest of the wound to evaluate inflammation and microvascular integrity.RESULTSAll 3 nonhealing DFUs treated with weekly topical PMVT healed within 12 weeks (average, 6.3 ± 5.5 weeks). Assessment of healed wounds at the time of closure indicated PMVT treatment significantly improved perfusion within the newly healed wounded area and throughout the immediate surrounding tissues. No wound recurrence or tissue deterioration has been observed in more than 9 months of follow-up.CONCLUSIONSIn this series of patients, the PMVT graft demonstrated improved wound closure, increased local perfusion and vascular maturity, and improved tissue quality. This graft is a promising advanced tissue therapy for nonhealing DFUs and other complex wounds. It is now the subject of a randomized controlled trial.

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