NanoSALV vs Standard Topical Care Pathway in Sports-Related Skin Lesions

Brief Summary

This randomized, double-blind, two-arm parallel trial evaluates the efficacy of NanoSALV Catalytic for treating acute, sport-related friction blisters in ultra-distance runners. NanoSALV is an advanced wound care technology designed to engage the body's copper-dependent healing pathways, offering a novel approach compared to conventional products that rely solely on moisture balance or infection control. The primary objective is to determine whether NanoSALV Catalytic increases the rate of reduction in friction blister area (mm²) over a 14-day treatment period compared to a Standard Topical Care Pathway. Secondary objectives assess the time to complete healing, the proportion of blisters healed by Day 14, self-reported pain, participant satisfaction, post-event running activity, and the incidence of adverse events. The study aims to enroll 100 otherwise injury-free participants (aged 18-65) who develop at least one acute friction blister following an ultra-distance running event in Alberta. Participants are randomized in a 1:1 ratio to receive either NanoSALV Catalytic (Arm A) or a Standard Topical Care Pathway (Arm B). To maintain blinding, both groups are provided with identical unbranded tubes and standard hydrocolloid blister dressings. Participants self-administer the treatment daily for 14 days. At each daily dressing change, participants photograph the index blister alongside a true-to-size scale marker and submit the images through a secure, PIPEDA-compliant platform. To ensure objective results, digital image metadata is scrubbed, and the lesion area is traced and measured using digital software by a blinded researcher. A blinded plastic surgeon provides clinical observations and determines final healing status. Participants also complete electronic surveys to record daily pain levels, running activity, and adverse events, concluding with an end-of-treatment survey to evaluate overall satisfaction. The primary outcome will be analyzed using a linear mixed-effects model to compare the rate of blister area reduction between the two treatment arms over time.

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