Wound HealMicrolyteNCT03204851
Microlyte Dressing in the Management of Wounds
A study testing Wound Healing in people with Wound Heal, run by Mission Health System, Asheville, NC at 1 site in United States.
Trial summary
The purpose of this pilot study is to assess the efficacy of Microlyte Ag wound dressing when used in complex skin wounds. Microlyte Ag is a class-II medical device cleared by the FDA for prescription and over the counter use in humans. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Wound Heal
- What is being tested?
- Wound Healing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2016to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women ≥18 years of age, inclusive
- Venous stasis ulcer, DFU, pressure ulcer, or other wound sufficiently complex as to be referred to Clinical Investigators at Mission's Wound Care and Bariatric Center
- Patient must be competent to consent for self
Who cannot join
- Patients younger than 18 years of age
- Women who are pregnant or nursing
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Mission Health System
Asheville, North Carolina, 28801
Ashley Boone, BS, 828-213-3961, ashley.boone@msj.org
Nicole Gunn, MA, 828-213-7055, nicole.gunn@msj.org
About this study
Official title: An Open-Label Prospective Pilot Study to Evaluate the Efficacy and Tolerability of Microlyte Ag Pre-Dressing in the Management of Complex Skin Wounds.
The purpose of this pilot study is to assess the efficacy of Microlyte Ag wound dressing when used in complex skin wounds. Microlyte Ag is a class-II medical device cleared by the FDA for prescription and over the counter use in humans. Primary clinical end point of study is percentage change in wound size from initiation of Microlyte Ag treatment through 90 days or until wound closure. Patient population comprises patients referred to Mission's Wound Healing and Hyperbaric Center for management of their wounds. Targeted enrollment is 100 subjects distributed into 4 study cohorts corresponding to the type of wound treated: venous stasis ulcer (20 patients); diabetic foot ulcer [DFU] (20 patients); pressure ulcer (20 patients); wounds of various other etiologies (40 patients).
- Conditions
- Wound Heal
- Being tested
- Wound Healing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wound HealingDevice
Microlyte Ag is a class-II medical device cleared by the FDA for prescription and over the counter use in humans with skin wounds.
| Study group | Role | What they receive |
|---|---|---|
| Venous Stasis Ulcer | Active comparator | Venous Stasis Ulcer Receives: Device: Wound Healing |
| Pressure Ulcers | Active comparator | Pressure Ulcers Receives: Device: Wound Healing |
| Diabetic Foot Ulcers | Active comparator | Diabetic Foot Ulcers Receives: Device: Wound Healing |
| Wounds from a variety of etiologies | Active comparator | Wounds from a variety of etiologies Receives: Device: Wound Healing |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage change in wound size from initiation of Microlyte Ag treatment through 90 days or until wound closure.
Wound Healing
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start20 Oct 2016
- Primary completion1 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mission Health System, Asheville, NC
- Sponsor type
- University, hospital or other
- Collaborators
- Imbed Biosciences
- Responsible party
- Sponsor
- Investigators
- William Shillinglaw, DO, Study chair, Mission Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03204851
- Sponsor's protocol ID
- 16-08-1608
- Acronym
- Microlyte
- Status last verified
- Feb 2020
- First submitted
- 28 Jun 2017
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Prospective Pilot Study to Evaluate the Efficacy and Tolerability of Microlyte Ag Pre-Dressing in the Management of Complex Skin Wounds.
- ClinicalTrials.gov ID
- NCT03204851
- Acronym / sponsor ID
- Microlyte / 16-08-1608
- Conditions
- Wound Heal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mission Health System, Asheville, NCUniversity, hospital or other
- Collaborators
- Imbed Biosciences
- Study start
- 20 Oct 2016 (actual)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 2 Jul 2017 (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.
The purpose of this pilot study is to assess the efficacy of Microlyte Ag wound dressing when used in complex skin wounds. Microlyte Ag is a class-II medical device cleared by the FDA for prescription and over the counter use in humans. Primary clinical end point of study is percentage change in wound size from initiation of Microlyte Ag treatment through 90 days or until wound closure. Patient population comprises patients referred to Mission's Wound Healing and Hyperbaric Center for management of their wounds. Targeted enrollment is 100 subjects distributed into 4 study cohorts corresponding to the type of wound treated: venous stasis ulcer (20 patients); diabetic foot ulcer [DFU] (20 patients); pressure ulcer (20 patients); wounds of various other etiologies (40 patients).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Venous Stasis Ulcer | Active comparator | Device: Wound HealingVenous Stasis Ulcer |
| Pressure Ulcers | Active comparator | Device: Wound HealingPressure Ulcers |
| Diabetic Foot Ulcers | Active comparator | Device: Wound HealingDiabetic Foot Ulcers |
| Wounds from a variety of etiologies | Active comparator | Device: Wound HealingWounds from a variety of etiologies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women ≥18 years of age, inclusive
- Venous stasis ulcer, DFU, pressure ulcer, or other wound sufficiently complex as to be referred to Clinical Investigators at Mission's Wound Care and Bariatric Center
- Patient must be competent to consent for self
Key exclusion criteria (3 listed)
- Patients younger than 18 years of age
- Women who are pregnant or nursing
- Prisoners
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 |
|---|---|---|
| Wound HealingMicrolyte Ag is a class-II medical device cleared by the FDA for prescription and over the counter use in humans with skin wounds. | Device | Diabetic Foot Ulcers, Pressure Ulcers, Venous Stasis Ulcer, Wounds from a variety of etiologies |
Primary outcome
percentage change in wound size from initiation of Microlyte Ag treatment through 90 days or until wound closure.
Time frame: 90 days
Wound Healing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
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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. This study is not recruiting at the moment.
William Shillinglaw, DO study chair
Mission Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wound Healing in people with Wound Heal, run by Mission Health System, Asheville, NC at 1 site in United States.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lorinda Baker (828-257-4744, lorinda.baker@hcahealthcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage change in wound size from initiation of Microlyte Ag treatment through 90 days or until wound closure. (time frame: 90 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 25 Feb 2020.