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Antimicrobial
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
N/A
Waitlist Available
Research Sponsored by SerenaGroup, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4-weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial tests two treatments for hard-to-heal leg sores: one using saltwater and a moisturizing gel, and another using a germ-killing cleaner and an antimicrobial gel, to see which heals faster.
Eligible Conditions
- Cuts
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4-weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4-weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Compare healing rates (percent area reduction) through digital device
Secondary study objectives
Adverse Events
Compare the reduction in bacterial bioburden
Pain Score
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: synergistic antimicrobial cleanser (AMC) and antimicrobial gel (AMG)Experimental Treatment1 Intervention
Antimicrobial Skin \& Wound Cleanser helps in the mechanical removal of debris and foreign material from the skin, wound, or application site. BIAKOS™
BIAKŌS Antimicrobial Wound Gel provides a moist environment to wound surfaces. BIAKŌS Antimicrobial Wound Gel is a safe and gentle colorless gel.
Group II: Normal saline wash and an amorphous gel (NSS-HG)Active Control1 Intervention
Normal Saline Wash and Amorphous Gel
Find a Location
Who is running the clinical trial?
SerenaGroup, Inc.Lead Sponsor
30 Previous Clinical Trials
3,504 Total Patients Enrolled
Sanara MedTechUNKNOWN