Comparing a Synergistic Antimicrobial Cleanser and Gel to Normal Saline and an Amorphous Gel in Reducing Bioburden and Promoting Healing in Chronic Lower Extremity Ulcers
Public ClinicalTrials.gov record NCT05107050. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized Double-blind Controlled Clinical Trial Comparing a Synergistic Antimicrobial Cleanser and Gel to Normal Saline and an Amorphous Gel in Reducing Bioburden and Promoting Healing in Chronic Lower Extremity Ulcers
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The study is a randomized double-blind controlled clinical trial designed to compare healing rates between normal saline wash in combination with an amorphous gel (NSS-HG) versus the grouping of a synergistic antimicrobial cleanser (AMC) and antimicrobial gel (AMG) in chronic lower extremity ulcers. After consenting, the ulcers of eligible subjects are measured, photographed and undergo the MolecuLight imaging procedure (MiX). The subject is then randomized to one of two arms: target ulcer cleansed saline wash and an amorphous gel (NSS-HG) or synergistic antimicrobial cleanser (AMC) and antimicrobial gel (AMG). After cleansing the wound a second MiX is performed. The subject is given a four-week supply.
Study identification
- NCT ID
- NCT05107050
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 60 participants
Conditions and interventions
Conditions
Interventions
- Normal Saline and Amorphous gel Device
- BIAKOS™ Antimicrobial Skin & Wound Cleanser, BIAKŌS Antimicrobial Wound Gel Device
Device
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 30, 2021
- Primary completion
- Apr 30, 2023
- Completion
- May 24, 2023
- Last update posted
- Apr 25, 2023
2021 – 2023
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The Serens Group Austin Research Center | Austin | Texas | 78701 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05107050, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 25, 2023 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05107050 live on ClinicalTrials.gov.