Blister of FootPhase 3NCT07807904
NanoSALV vs Standard Topical Care Pathway in Sports-Related Skin Lesions
A Phase 3 study testing NanoSALV Catalytic and Standard Topical Care Pathway in people with Blister of Foot and Blister, run by Shahab Alizadeh.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Blister of Foot, Blister
- What is being tested?
- NanoSALV Catalytic and Standard Topical Care Pathway
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 31 May 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age and Demographics: Male or female adults between the ages of 18 and 65 years.
- Justification: This range captures the standard demographic of the target athletic population. It also ensures all participants are legally capable of providing independent informed consent while minimizing extreme age-related confounding factors that could independently alter skin integrity and wound healing rates.
- Target Condition and Activity: Participants must have completed an ultra-distance running event and present to the research team with at least one acute friction blister.
- Justification: Ultra-distance running provides an ideal, highly reliable environment for investigating this application, as athletes frequently develop severe friction blisters during these competitions despite utilizing preventative measures. Targeting this specific event type ensures a relevant, homogeneous sample for comparing the localized time to healing between the study interventions.
- General Health Status: Participants must be otherwise injury-free.
- Justification: Ensuring participants do not have concurrent acute or severe musculoskeletal injuries minimizes confounding variables. Secondary injuries could alter systemic inflammatory responses, subjective pain perception, or overall recovery timelines, which would make it difficult to isolate the specific localized effects of NanoSALV Catalytic and the Standard Topical Care Pathway.
- Capacity to Complete Remote Data Collection: Participants must be willing and able to photograph the index lesion at each dressing change over the 14-day treatment period using their own smartphone, to complete a short questionnaire at each scheduled assessment, and to use the secure image transmission platform (Brightsquid Secure Mail).
- Justification: All outcome data are collected remotely after enrolment, with no scheduled in-person study visit. A participant who cannot reliably photograph the lesion and transmit images securely cannot contribute to the primary outcome.
Who cannot join
- Known Allergies or Sensitivities to Study Interventions: Individuals with a known allergy to any active or inactive ingredients utilized in either treatment arm, including bacitracin, polymyxin B, gramicidin, petrolatum, or copper-based compounds.
- Justification: This is a primary safety measure to prevent severe allergic contact dermatitis or systemic hypersensitivity reactions. To maintain the double-blinded integrity of the study, the screening process will not ask participants about specific brand names directly. Instead, participants will be screened using a consolidated list of specific ingredients present across all products to ensure potential allergens are avoided without revealing the exact nature of the interventions.
- Underlying Medical Conditions Affecting Wound Healing: Individuals with systemic conditions known to impair tissue repair or alter skin integrity, such as diabetes mellitus, peripheral vascular disease, or autoimmune disorders.
- Justification: These conditions inherently alter physiological healing timelines and subjective sensory perception (e.g., peripheral neuropathy). Excluding these individuals controls for significant confounding variables, ensuring that any statistical differences in healing time can be directly attributed to the topical interventions.
- Pre-existing Severe Infection of the Target Lesion: Participants presenting with friction blisters that already exhibit clinical signs of severe or systemic infection, such as excessive purulent discharge, spreading erythema, or red streaking, prior to group assignment.
- Justification: Wounds with severe pre-existing infections require immediate standard medical care, such as oral antibiotics. Including these lesions would compromise participant safety and skew the baseline healing trajectory compared to standard, acute friction blisters.
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- Concurrent Use of Alternative Wound Treatments: Individuals currently utilizing other topical antibiotics, corticosteroid creams, or systemic immunosuppressive medications.
- Justification: The concurrent use of active pharmacological agents introduces confounding treatment effects. This would make it scientifically impossible to isolate the primary main effect of NanoSALV Catalytic or the Standard Topical Care Pathway on the wound area.
- Presence of Acute or Severe Musculoskeletal Injuries: Individuals who sustained major acute injuries during the ultra-distance event.
- Justification: Secondary trauma alters systemic inflammatory responses and subjective pain perception. This systemic noise complicates the localized subjective assessments, such as the Visual Analog Scale (VAS) for pain perception.
- Pregnancy or Breastfeeding: Individuals who are pregnant or breastfeeding.
- Justification: This is a contraindicated population for the standard, over-the-counter components utilized in the Standard Topical Care Pathway.
- Blood Blisters: Lesions that are blood blisters rather than clear friction blisters are not eligible to serve as the index lesion.
- Justification: Blood blisters involve dermal vessel injury and follow a different physiological healing trajectory. Including them would introduce heterogeneity into the primary outcome.
About this study
Official title: Evaluating the Efficacy of NanoSALV Catalytic Compared to a Standard Topical Care Pathway in Sports-Related Skin Lesions
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.
Read more
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.
- Conditions
- Blister of Foot, Blister
- Being tested
- NanoSALV Catalytic, Standard Topical Care Pathway
- Medical subject headings
- Blister
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NanoSALV CatalyticDevice
NanoSALV Catalytic is an advanced skin and wound care technology featuring a proprietary catalytic surface. It is designed to engage the body's copper-dependent healing pathways to promote healing, modulate inflammation, and provide broad-spectrum antimicrobial protection.
Stage 1 \& 2 (Days 1 to 14): Participants receive NanoSALV Catalytic for the entire 14-day treatment period. To maintain the double-blind design and match the two-stage administration of the active comparator, NanoSALV Catalytic is supplied in two unbranded, coded tubes (Tube 1 for Days 1-7; Tube 2 for Days 8-14).
Administration: Participants apply a thin layer of NanoSALV Catalytic to the index friction blister every 24 hours. Immediately following application, the lesion is covered with a standard hydrocolloid blister dressing. Both the written instructions and the packaging are identical to those provided to the comparator arm.
Standard Topical Care PathwayDrug
The Standard Topical Care Pathway is a two-stage topical treatment regimen administered over a fixed 14-day period.
Stage 1 (Days 1 to 7): Participants apply a standard over-the-counter topical antibiotic ointment.
Stage 2 (Days 8 to 14): Participants transition to applying a standard white petroleum jelly. This two-stage approach is utilized to ensure the topical antibiotic is not used beyond its authorized 7-day indication.
Administration: Participants apply a thin layer of the designated topical product to the index friction blister every 24 hours. Immediately following application, the lesion is covered with a standard hydrocolloid blister dressing.
Blinding: To maintain the double-blind study design, the Standard Topical Care Pathway is provided to participants in two unbranded, coded tubes (Tube 1 for Days 1-7; Tube 2 for Days 8-14) that are visually indistinguishable from the investigational product packaging.
| Study group | Role | What they receive |
|---|---|---|
| NanoSalv Catalytic | Experimental | Not described Receives: Device: NanoSALV Catalytic |
| Standard Topical Care Pathway | Active comparator | Not described Receives: Drug: Standard Topical Care Pathway |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blister Area
Measured: From enrollment to the end of treatment at 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blister of FootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahab Alizadeh
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Sport Institute Alberta
- Responsible party
- Sponsor-investigator, Shahab Alizadeh, Canadian Sport Institute Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07807904
- Sponsor's protocol ID
- HREBA.CTC-26-0140
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of NanoSALV Catalytic Compared to a Standard Topical Care Pathway in Sports-Related Skin Lesions
- ClinicalTrials.gov ID
- NCT07807904
- Acronym / sponsor ID
- HREBA.CTC-26-0140
- Conditions
- Blister of Foot, Blister
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shahab AlizadehUniversity, hospital or other
- Collaborators
- Canadian Sport Institute Alberta
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 8 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NanoSalv Catalytic | Experimental | Device: NanoSALV Catalytic |
| Standard Topical Care Pathway | Active comparator | Drug: Standard Topical Care Pathway |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age and Demographics: Male or female adults between the ages of 18 and 65 years.
- Justification: This range captures the standard demographic of the target athletic population. It also ensures all participants are legally capable of providing independent informed consent while minimizing extreme age-related confounding factors that could independently alter skin integrity and wound healing rates.
- Target Condition and Activity: Participants must have completed an ultra-distance running event and present to the research team with at least one acute friction blister.
- Justification: Ultra-distance running provides an ideal, highly reliable environment for investigating this application, as athletes frequently develop severe friction blisters during these competitions despite utilizing preventative measures. Targeting this specific event type ensures a relevant, homogeneous sample for comparing the localized time to healing between the study interventions.
- General Health Status: Participants must be otherwise injury-free.
Key exclusion criteria (14 listed)
- Known Allergies or Sensitivities to Study Interventions: Individuals with a known allergy to any active or inactive ingredients utilized in either treatment arm, including bacitracin, polymyxin B, gramicidin, petrolatum, or copper-based compounds.
- Justification: This is a primary safety measure to prevent severe allergic contact dermatitis or systemic hypersensitivity reactions. To maintain the double-blinded integrity of the study, the screening process will not ask participants about specific brand names directly. Instead, participants will be screened using a consolidated list of specific ingredients present across all products to ensure potential allergens are avoided without revealing the exact nature of the interventions.
- Underlying Medical Conditions Affecting Wound Healing: Individuals with systemic conditions known to impair tissue repair or alter skin integrity, such as diabetes mellitus, peripheral vascular disease, or autoimmune disorders.
- Justification: These conditions inherently alter physiological healing timelines and subjective sensory perception (e.g., peripheral neuropathy). Excluding these individuals controls for significant confounding variables, ensuring that any statistical differences in healing time can be directly attributed to the topical interventions.
- Pre-existing Severe Infection of the Target Lesion: Participants presenting with friction blisters that already exhibit clinical signs of severe or systemic infection, such as excessive purulent discharge, spreading erythema, or red streaking, prior to group assignment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NanoSALV CatalyticNanoSALV Catalytic is an advanced skin and wound care technology featuring a proprietary catalytic surface. It is designed to engage the body's copper-dependent healing pathways to promote healing, modulate inflammation, and provide broad-spectrum antimicrobial protection. Stage 1 \& 2 (Days 1 to 14): Participants receive NanoSALV Catalytic for the entire 14-day treatment period. To maintain the double-blind design and match the two-stage administration of the active comparator, NanoSALV Catalytic is supplied in two unbranded, coded tubes (Tube 1 for Days 1-7; Tube 2 for Days 8-14). Administration: Participants apply a thin layer of NanoSALV Catalytic to the index friction blister every 24 hours. Immediately following application, the lesion is covered with a standard hydrocolloid blister dressing. Both the written instructions and the packaging are identical to those provided to the comparator arm. | Device | NanoSalv Catalytic |
| Standard Topical Care PathwayThe Standard Topical Care Pathway is a two-stage topical treatment regimen administered over a fixed 14-day period. Stage 1 (Days 1 to 7): Participants apply a standard over-the-counter topical antibiotic ointment. Stage 2 (Days 8 to 14): Participants transition to applying a standard white petroleum jelly. This two-stage approach is utilized to ensure the topical antibiotic is not used beyond its authorized 7-day indication. Administration: Participants apply a thin layer of the designated topical product to the index friction blister every 24 hours. Immediately following application, the lesion is covered with a standard hydrocolloid blister dressing. Blinding: To maintain the double-blind study design, the Standard Topical Care Pathway is provided to participants in two unbranded, coded tubes (Tube 1 for Days 1-7; Tube 2 for Days 8-14) that are visually indistinguishable from the investigational product packaging. | Drug | Standard Topical Care Pathway |
Primary outcome
Blister Area
Time frame: From enrollment to the end of treatment at 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NanoSALV Catalytic and Standard Topical Care Pathway in people with Blister of Foot and Blister, run by Shahab Alizadeh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blister Area (time frame: From enrollment to the end of treatment at 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.