Clinical Data

USE OF AN INNOVATIVE SYNTHETHIC SELF-ASSEMBLING PEPTIDE MATRIX IN THE TREATMENT OF THREE LARGE RECALCITRANT 20-YEAR-OLD VENOUS LEG ULCERS – A CASE STUDY

Misael Alonso, MD, FACP, CWSP, FAPWCA

Presented at SAWC Fall 2023

Conclusion: This case study presents a novel and innovative SSAPM for the treatment of recalcitrant VLUs. The synthetic peptide matrix is made of a proprietary peptide synthesized from natural occurring amino acids. Upon exposure to ions in the wound, the peptide matrix self-assembles into a nanofiber network that mimics an extracellular matrix, providing a physical barrier to mitigate contamination and modulate inflammation and a scaffold to facilitate tissue growth and repair. Each wound improved dramatically and progressed toward healing. The SSAPM demonstrated wound healing efficacy in previously non-responsive wounds and should be part of the wound treatment plan.

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The Use of a Synthetic Self-Assembling Peptide Matrix in a Limb Salvage Setting

Christopher Gauland, DPM, East Carolina University – Brody School of Medicine

Presented at SAWC Fall 2022

Conclusion: The novel synthetic self-assembling peptide matrix is made of a proprietary peptide synthesized from naturally occurring amino acids. Upon exposure to ions in the wound, the peptide matrix self-assembles into a nanofiber network that provides a physical barrier to help mitigate contamination and modulate inflammation. In addition, the self-assembling peptide mimics the extracellular matrix as a scaffold to facilitate tissue growth and repair. The product is easy to apply, conforms to irregular wound geometry, and requires no cold chain storage. This case report demonstrates the patient’s rapid onset of wound granulation, a considerable decrease in pain, and return to work in a setting in which amputation had been strongly recommended. The experience with this proprietary self-assembling peptide matrix shows its use as a viable wound management solution for the treatment of hard-to-heal wounds. Further studies are recommended to determine its additional benefits and effectiveness across the spectrum of both acute and chronic wounds.

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Treatment of Hard to Heal Acute and Chronic Wounds with a Synthetic Self-Assembling Peptide Matrix

Terry Treadwell, MD, FACS, FAAWC and Lyudmila Nikolaychook, DO

Presented at SAWC Fall 2022

Conclusion: The synthetic self-assembling peptide matrix was effective in the treatment of hard-to-heal wounds. Further studies are recommended to confirm the optimal application frequency for different wound types.

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A New Treatment Modality to Expedite Healing in the Case of a Transmetatarsal Breakdown

Jean W. Gillon, MD - Vascular Surgeon, Sequoia Hospital

Presented at SAWC Spring 2022

Conclusion:  The acceleration of wound healing as a result of the surgeon's treatment strategy played a crucial role in avoiding a BKA. As this is a single case study design, the conclusions drawn are limited to this particular case. Treatment of other patients with this new wound system may provide better understanding and outcomes for diverse wounds prone to failure and breakdown.

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Optimizing the Wound Bed for Application of a Skin Graft with a Novel Adaptive Self-Assembling Peptide Barrier Scaffold and Peptide Technology

Thomas Davenport MD; Steven Stavrides, PA; Jaimee Napolitano, BS, Long Island Plastic Surgical Group NYU, Long Island Medical School

Presented at SAWC Spring 2022

Conclusion:  Both patients were followed for 3 months with continued closure of the wounds. These case reports demonstrate good results with the use of the aSABS in conjunction with skin grafting in two different scenarios of wound bed preparation ahead of a graft. Additional larger or prospective studies may be helpful to further evaluate this technology in these applications.

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Effective Management of a Non-Healing Wound Post-Mohs Surgery Using a Novel Self-Assembling Peptide-Based Advanced Wound Dressing

Laura Pfendler PT, DPT (Director, Advanced Wound Care, Kapp Plastic Surgery & Wound Care), Kalpana Kamath PhD (Consultant, Arch Therapeutics, Inc.), Daniel C Wadsworth Jr (VP Dermal Sciences, Arch Therapeutics, Inc.), Daniel Kapp MD (Chief of Plastic Surgery and Wound Care, Palm Beach Gardens Medical Center)

Presented at SAWC Spring 2021

Conclusion: Concomitant use of excisional debridement and treatment with AC5 markedly accelerated healing of this stalled wound, which had failed two months of standard therapy. The effect of AC5 may be attributed to the contiguous barrier it creates along the wound surface after debridement, in addition to its ability to promote cell adhesion, migration, and proliferation, which are essential for wound healing.

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Rapid Healing of a Chronic Trophic Ulcer In a Patient With Peripheral Vascular and Autoimmune Comorbidities Using a Novel Self-Assembling Peptide-Based Advanced Wound Dressing

Laura Pfendler PT, DPT (Director, Advanced Wound Care, Kapp Plastic Surgery & Wound Care), Kalpana Kamath PhD (Consultant, Arch Therapeutics, Inc.), Daniel C Wadsworth Jr (VP Dermal Sciences, Arch Therapeutics, Inc.), Daniel Kapp MD (Chief of Plastic Surgery and Wound Care, Palm Beach Gardens Medical Center)

Presented at SAWC Spring 2021

Conclusion: Complete healing of this recalcitrant trophic ulcer, which was unresponsive to multiple wound management regimens during the prior four years, was achieved with only three applications of AC5 in less than three weeks. The phenomenon was particularly impressive, considering the patient’s multiple vascular and autoimmune diseases, known to hinder the progression of wound healing and likely contributing to failure of prior wound-care regimens.

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Healing of a Complex Surgical Wound using a Novel Self-Assembling Peptide-based Advanced Wound Dressing

Dan Kapp, MD (Chief of Surgery, Palm Beach Gardens Medical Center) and Terrence Norchi, MD (Arch Therapeutics)

Presented at SAWC Fall Virtual 2020

Conclusion: AC5 Advanced Wound System, a novel self-assembling peptide-based advanced wound dressing, quickly restarted the previously stalled healing process in this complex surgical wound. The results indicate that the use of this dressing may obviate the need for continued costly treatments and procedures, thus reducing the total cost of lower extremity wound care, while improving patient’s quality of life.

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Healing of a Chronic Refractory Burn Wound with a Novel Self-Assembling Peptide-based Advanced Wound Dressing

Randall Wolcott, MD (Wound & Burn Specialist, Southwest Regional Wound Care Center) and Kalpana Kamath, PhD (Arch Therapeutics)

Presented at SAWC Fall Virtual 2020

Conclusion: The aggressive debridement made possible by the application of AC5 Advanced Wound System, the novel self-assembling peptide-based advanced dressing, facilitated the removal of the infected granulation tissue. This reduction in the wound bioburden likely helped address one of the major stimuli contributing to the chronicity and severity of these types of wounds. Subsequently, the advanced wound dressing appears to have not only enabled accelerated healing of this stalled refractory burn wound, but it also provided a marked improvement in the patient’s quality-of-life.

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Enabling Aggressive Surgical Debridement and Healing in a 10-year-old Decubitus Ulcer with a Novel Self-Assembling Peptide-based Advanced Wound Dressing

Randall Wolcott, MD (Wound & Burn Specialist, Southwest Regional Wound Care Center, Terrence Norchi, MD (Arch Therapeutics) and Daniel Wadsworth (Arch Therapeutics)

Presented at SAWC Fall Virtual 2020

Conclusion: Concomitant use of debridement and the novel self-assembling peptide-based AC5 Advanced Wound System, which formed a clear conforming dressing over the wound surface, allowed for a more aggressive procedure with bleeding control in a low acuity clinic setting and without the need for thrombin or sutures. In addition, the nanofiber network appeared to cohesively seal the wound bed surface after debridement made the wound devoid of biofilm and senescent host cells. The resulting scaffold allowed for the adhesion, migration, and proliferation of healthy host cells and favorable wound healing outcomes.

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Self-Assembling Peptide Barrier Hemostatic Device

The tested device is known as AC5 Advanced Wound System in the USA and AC5 Topical Hemostat in Europe, respectively, where it has received marketing authorizations.)

Randomized, blinded safety study of 46 patients undergoing cutaneous surgery, including 10 patients on antiplatelet therapy (blood thinner). Each patient underwent shave excision of 2 lesions, which were randomized to AC5® or control treatment.

AC5® met the primary safety and secondary performance endpoints

  • Safety profiles similar between AC5®- and control-treated wounds (30-day follow up)
  • No serious adverse effects noted
  • 41% statistically significant improvement in median time to hemostasis (TTH) with AC5® vs control
  • TTH ≤30 seconds in groups of AC5®-treated wounds (+/- antiplatelet therapy)

Rahmani G et al. Dermatol Surg. 2018;44:939–948.

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