Regenerative Topical Therapy for Cold-Induced Skin Injury: A Field-Ready Solution to Prevent Necrosis and Amputation
This is a novel, non-systemic hydrogel comprising a proprietary conjugate of Hyaluronic Acid and Metformin. It is the first-in-class topical regenerative therapy designed to restore near-normal skin architecture and adnexal structures following severe cold-induced injuries like frostbite.
Description
The technology combines hyaluronic acid (HA) with metformin through covalent conjugation to create a biocompatible hydrogel with dual regenerative and anti-inflammatory properties. The HA component provides a protective, moisture-retaining matrix that supports tissue scaffolding, while the conjugated metformin is released in a controlled manner to reduce inflammation, enhance microvascular perfusion, and reduce thrombotic risk at the injury site. The conjugate is synthesized through EDC/NHS-mediated coupling, forming stable amide bonds between HA's carboxyl groups and metformin's amino groups, with typical conjugation at 1-10% of available carboxyl sites. The hydrogel formulation can be applied directly to frostbite injuries in the field or clinical settings, forming a protective film that delivers therapeutic agents directly to damaged tissue. The formulation incorporates anti-freezing agents like propylene glycol or glycerol to maintain stability at freezing temperatures, making it uniquely suited for cold-weather deployment. Pre-clinical studies demonstrate complete re-epithelialization, organized collagen remodeling, balanced type I/III collagen distribution, restored adnexal structures (hair follicles, sebaceous glands, sweat glands), and robust vascularization within two weeks of treatment.Applications
- Military and Defense: Field treatment for soldiers and personnel exposed to extreme cold environments during operations or training.- Emergency Medical Services: Pre-hospital care for frostbite victims in civilian settings, mountain rescue operations, and disaster response scenarios.
- Outdoor Recreation Industry: Treatment supplies for mountaineering expeditions, polar exploration, skiing facilities, and cold-weather sports venues.
- Occupational Health: Protection for workers in cold storage facilities, arctic research stations, fishing vessels, and other cold-exposure occupations.
- Veterinary Medicine: Treatment of cold-induced injuries in working animals, livestock, and domestic pets exposed to extreme weather.
Advantages
- Regenerative Treatment: Promotes complete re-epithelialization and the regeneration of adnexal structures (e.g., hair follicles), restoring near-normal skin architecture that existing systemic treatments fail to achieve.- Field-Deployable: Designed for topical, non-systemic application, making it practical for immediate pre-hospital or field use where systemic treatments are impossible.
- Reduced Scarring & Pain: Mitigates fibrotic remodeling, significantly lessening scar tissue formation, and has been shown to suppress pro-inflammatory cytokines that contribute to chronic neuropathic pain.
- Vascular and Cellular Protection: Offers a dual mechanism of action that targets both acute ischemia–reperfusion injury and chronic maladaptive inflammation, enhancing microvascular perfusion and helping prevent thrombosis.
- Amputation Risk Reduction: By preserving tissue viability and locally modulating the severe inflammatory response, the hydrogel may prevent the progression of injury to necrosis and subsequent amputation.