Charles M. Zelen

Anatomically Directed Lower Extremity Gene Therapy for Ulcer Healing: A Double-Blind, Randomized, Placebo-Controlled Study (LEGenD-1)

David G. Armstrong, Michael S. Conte, Joseph L. Mills, Matthew T. Menard et autres

BACKGROUND: People with chronic limb-threatening ischemia lack Food and Drug Administration-approved therapies for wound healing, creating an unmet need for novel approaches. Prior studies of biologics in chronic limb-threatening ischemia have largely targeted end-stage patients with amputation-free survival as the primary outcome. …

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A Borate‐Based Bioactive Glass Advances Wound Healing in Non‐Healing Wagner Grade 1 Diabetic Foot Ulcers: A Randomised Controlled Clinical Trial

David G. Armstrong, Dennis Paul Orgill, Robert D. Galiano, John C Lantis et autres

A novel advanced synthetic bioactive glass matrix was studied in patients with non-healing diabetic foot ulcers (DFUs). Bioactive glasses can be constructed to be biocompatible, with water-soluble materials in multiple geometries including fibre scaffolds that mimic the 3D architecture of a fibrin …

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Comparing the Efficacy of a Unique Advanced Bioengineered Type-I Collagen-Based Skin Substitute Versus an Amnion Graft With Standard of Care in the Treatment of Non-healing Diabetic Foot Ulcers: A Randomized Clinical Trial

David G. Armstrong, Jason R. Hanft, Maria S. Surprenant, Adam L. Isaac et autres

The increased cost and morbidity associated with diabetic foot ulcers (DFUs) place a substantial strain on the entire global healthcare system. In this trial, 24 subjects with a chronic DFU, Wagner grade 1 (University of Texas grade 1A), were treated with Standard …

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Retrospective Analysis of the Effect of Vaporous Hyperoxia Therapy as an Adjunct to Standard Wound Care in Chronic Wounds

David G. Armstrong, Dustin L. Kruse, Marissa Janine Carter, Charles M. Zelen et autres

BACKGROUND: Considering the rising incidence and cost associated with chronic wounds, further investigation of safe and effective treatments is needed. OBJECTIVE: To conduct a retrospective analysis of patients with chronic wounds in order to evaluate the healing effect of vaporous hyperoxia therapy …

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A multicentre clinical trial evaluating the outcomes of two application regimens of a unique keratin‐based graft in the treatment of Wagner grade one non‐healing diabetic foot ulcers

David G. Armstrong, Dennis Paul Orgill, Robert D. Galiano, Paul M. Glat et autres

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 …

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Paul M Glat MD: a life of service

David G. Armstrong, Charles M. Zelen

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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

David G. Armstrong, Dennis Paul Orgill, Robert D. Galiano, Paul M. Glat et autres

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 …

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First clinical evaluation of the safety and efficacy of tarumase for the debridement of venous leg ulcers

David M. Fairlamb, Kinga Szepeshazi, David Goldsmith, Peter Danos et autres

We report the first clinical evaluation of a new enzymatic wound debridement product containing tarumase in venous leg ulcer patients. As a first-in-human study, this was a prospective, open-label, multi-centre, dose escalation study across five dose cohorts and involving a total of …

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A Prospective Multicenter Study of a Weekly Application Regimen of Viable Human Amnion Membrane Allograft in the Management of Nonhealing Diabetic Foot Ulcers

Robert D. Galiano, Dennis Paul Orgill, David G. Armstrong, Paul M. Glat et autres

Background: 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 …

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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

David G. Armstrong, Dennis Paul Orgill, Robert D. Galiano, Paul M. Glat et autres

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 …

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29-LB: Multicenter, Randomized Controlled Clinical Investigation Evaluating a Unique Micro Water Jet Technology Device vs. Standard Debridement in the Treatment of Diabetic Foot Wounds

DAVID G. ARMSTRONG, Robert Galiano, Marissa Janine Carter, Charles M. Zelen

Background: Proper debridement of the wound base is critical to facilitate wound granulation and closure in non-healing diabetic foot ulcers(DFUs). A unique micro water jet device has been developed and recently granted breakthrough designation for treatment of DFUs by the Foot and …

Autologous Minimally Manipulated Homologous Adipose Tissue (AMHAT) for Treatment of Nonhealing Diabetic Foot Ulcers

David G. Armstrong, Steven G. Harris, Zachary L Rasor, Charles M. Zelen et autres

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 …

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