Page 94 - JCTR-11-2

Journal of Clinical and
Translational Research Biomimetic matrix used to treat diabetic foot ulcers

with often controversial or limited results, including the USA) synthesized to resemble the native ECM while
risk of rejection, infection, and impaired healing. 2 maintaining antibacterial activities. Eight patients with
Biomimetic matrix (BMM) is a fully synthetic matrix stalled chronic wounds present for 3 – 56 months were
composed of self-assembling peptides—an emerging enrolled in the study. The inclusion criteria were based
class of biomaterials recently applied to wound care. on wound chronicity (i.e., having a wound that has not
3
Self-assembling peptides are constructed from short decreased in size for at least 3 months) and lack of response
chains of synthetically derived amino acids capable of to previous standard of care and/or biologic treatments.
self-assembling into nano- and micro-structures, forming All subjects also had diabetes but there were no exclusions
a three-dimensional (3D) scaffold. Self-assembling is a based on hemoglobin A1C. In addition, all subjects failed
naturally occurring process involving the formation of previous treatment with advanced dressing materials
spontaneous peptide aggregates mediated by non-covalent and/or biologics including amniotic-derived materials,
intermolecular interactions. 4 decellularized collagen, and living cell/collagen products,
with no noticeable improvement. Subjects with purulent,
Self-assembling peptides can be synthesized in a draining wounds and active cellulitis were excluded. In
laboratory to mimic intricate, naturally occurring structures, addition, patients not able to comply with regular visits
taking advantage of their functional and dynamic properties scheduled every 2 weeks and unable to change their
applicable to wound healing. For instance, some synthetic dressings were excluded from the study.
5
peptides are capable of self-assembling into matrices or
biomimetic structures to facilitate cellular migration, All wounds were previously treated with topical
adhesion, and proliferation. They can also be engineered to antibiotics (bacitracin, silver sulfadiazine, mupirocin)
mimic naturally occurring structures with targeted features and wound irrigation solutions designed to reduce or
to produce enhanced therapeutic effects. Innovative eliminate bioburden (hypochlorous acid, Dakins solution,
6
materials derived from self-assembling peptides, such as povidone-iodine), in addition to appropriate off-loading
BMM, have potent cidal effects against microbial pathogens of the wound site. Before enrollment, all patients were
while sparing desirable mammalian cells. This antibacterial confirmed to have palpable dorsalis pedis and posterior
7,8
effect is achieved by introducing cationic peptides capable of tibial pulses on the wounded foot. A summary of the
interacting and disrupting negatively charged components patients enrolled, including wound location and size,
present in the bacterial membrane. Furthermore, through previous advanced treatments, and outcomes after BMM
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mimicking naturally occurring structures, such as the treatment, is provided in Table 1.
native extracellular matrix (ECM), synthetic self-assembling 2.2. Wound bed preparation and treatment
peptides are highly biocompatible, biodegradable, and
capable of interacting with biological ligands. By leveraging Wounds were thoroughly debrided of all non-viable tissue,
5
these advancements, self-assembling peptides open new cleaned with alcohol or hypochlorous acid solution, and
venues for advanced wound care by integrating multiple patted dry prior application of BMM. BMM is composed
therapeutic functions into a single, customizable biomimetic of synthetic self-assembling peptides that form a 3D
structure. BMM’s self-assembling peptide sequence was scaffolding wound matrix. The BMM delivery system is
specifically designed to provide a 3D scaffolding matrix that supplied sterile in a pre-filled syringe with an optional
resembles the dermal native ECM while offering antibacterial flexible applicator tip, each individually packaged in a
protection, a unique combination that is highly advantageous sterile peel pouch, ready to use for direct application to
for the healing of chronic and complex wounds. wounds. The flexible applicator tip allows precise delivery
to the wound site, facilitating application to irregularly
In this study, we review a series of eight cases in which shaped and/or hard-to-access wounds, such as tunneling
a novel self-assembling peptide-based BMM was used to or undermining areas. BMM is stable at room temperature
treat stalled, chronic diabetic foot ulcers (wounds present and does not require additional preparation. In this study,
for at least 3 months without any evidence of a decrease the supplied flexible applicator tip was attached directly to
in wound area) in patients with various comorbidities that the BMM’s sterile prefilled syringe for product application
did not respond to other advanced wound care products (Figure 1). BMM was applied across the entire wound
and/or biologic skin substitutes. surface until completely coated to a thickness of about a
2. Methods dime (approximately 1.3 mm).
After application, BMM and the entire wound surface
2.1. Patient enrollment were covered with a non-adhering and non-absorptive
This preliminary case series explores the potential dressing (Adaptic 3M, St. Paul, MN, USA) and backed by
clinical applications of a BMM (Gel4Med, Inc., MA, sterile gauze. Patients were instructed to leave the dressing

Volume 11 Issue 2 (2025) 88 doi: 10.36922/jctr.24.00063