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
NCT ID: NCT05107050
Last Updated: 2023-04-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
60 participants
INTERVENTIONAL
2021-12-01
2023-05-25
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Investigation of a Novel Wound Gel to Improve Wound Healing in Chronic Wounds
NCT03686904
Study Evaluating Several CAMPs in Nonhealing Diabetic Foot and Venous Leg Ulcers
NCT06562296
Evaluating Several Cellular, Acellular, and Matrix-like Products (CAMPs) and Standard of Care Versus Matched Standard of Care Controls in the Management of Nonhealing Pressure Ulcers
NCT06999590
Chlorhexidine Gluconate Solution at 0.125% vs Placebo for the Healing of Grade IIB Ulcers of Diabetic Foot
NCT03209466
Modified Multi-Platform Trial Assessing Multiple CAMPs and SOC vs SOC Alone in the Treatment of DFU and VLUs
NCT06560502
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
BIAKŌS Antimicrobial Wound Gel provides a moist environment to wound surfaces. BIAKŌS Antimicrobial Wound Gel is a safe and gentle colorless gel. The gel provides preservative properties through the antimicrobial PHMB. BIAKŌS Antimicrobial Wound Gel: • Resists microbial colonization within the gel during shelf storage. • Provides an amorphous gel covering. • Facilitates autolytic debridement through a moist wound environment. Wounds experience some level of autolytic debridement in which the body's own enzymes breakdown necrotic tissue.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Normal saline wash and an amorphous gel (NSS-HG)
Normal Saline Wash and Amorphous Gel
Normal Saline and Amorphous gel
Saline - sodium chloride and water Amorphous hydrogel dressings are formulations of water, polymers
synergistic antimicrobial cleanser (AMC) and antimicrobial gel (AMG)
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.
BIAKOS™ Antimicrobial Skin & Wound Cleanser, BIAKŌS Antimicrobial Wound Gel
Antimicrobial Skin \& Wound Cleanser helps in the mechanical removal of debris and foreign material from the skin, wound, or application site.
BIAKŌS Antimicrobial Wound Gel provides a moist environment to wound surfaces. BIAKŌS Antimicrobial Wound Gel is a safe and gentle colorless gel. The gel provides preservative properties through the antimicrobial PHMB. BIAKŌS Antimicrobial Wound Gel: • Resists microbial colonization within the gel during shelf storage. • Provides an amorphous gel covering. • Facilitates autolytic debridement through a moist wound environment. Wounds experience some level of autolytic debridement in which the body's own enzymes breakdown necrotic tissue.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Normal Saline and Amorphous gel
Saline - sodium chloride and water Amorphous hydrogel dressings are formulations of water, polymers
BIAKOS™ Antimicrobial Skin & Wound Cleanser, BIAKŌS Antimicrobial Wound Gel
Antimicrobial Skin \& Wound Cleanser helps in the mechanical removal of debris and foreign material from the skin, wound, or application site.
BIAKŌS Antimicrobial Wound Gel provides a moist environment to wound surfaces. BIAKŌS Antimicrobial Wound Gel is a safe and gentle colorless gel. The gel provides preservative properties through the antimicrobial PHMB. BIAKŌS Antimicrobial Wound Gel: • Resists microbial colonization within the gel during shelf storage. • Provides an amorphous gel covering. • Facilitates autolytic debridement through a moist wound environment. Wounds experience some level of autolytic debridement in which the body's own enzymes breakdown necrotic tissue.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Presence of a diabetic foot ulcer, Wagner 1 or 2 grade, extending at least through the dermis or subcutaneous tissue and may involve the tendon or muscle provided it is below the medial aspect of the malleolus OR Presence of a full thickness venous leg ulcer (VLU)
3. Index ulcer (i.e. current episode of ulceration) has been present for greater than 4 weeks prior to the initial screening visit.
4. Study ulcer size is a minimum of 0.75 cm2 and a maximum of 5 cm2 at first treatment visit for DFU OR a minimum of 2.0cm2 and a maximum of 20.0 cm2 at the first treatment visit for VLU.
5. Adequate circulation to the affected extremity as demonstrated by a transcutaneous oxygen measurement (TCOM) or a skin perfusion pressure (SPP) measurement of ≥ 30 mmHg, OR an Ankle Brachial Index (ABI - measure of blood flow to the ankle) between 0.7 and ≤ 1.3 OR a toe brachial index \>0.5 within 3 months of the first Screening Visit.
6. Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence).
7. Subject understands and is willing to participate in the clinical study and can comply with weekly visits and the follow-up regimen.
8. Subject has read and signed the IRB approved Informed Consent Form before screening procedures are undertaken.
Exclusion Criteria
2. A surgery for operative debridement or revascularization is planned for the ulcer to be treated.
3. Index ulcer has a history of cancer or, in the opinion of the investigator, is suspicious for cancer and should undergo an ulcer biopsy to rule out a carcinoma of the ulcer.
4. Subjects with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids \>10mg daily dose), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within one month prior to first Screening Visit, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study.
5. History of radiation at the ulcer site.
6. Subject with DFUs who cannot adhere to strict offloading according to protocol standards in the opinion of the investigator.
7. Subjects with VLUs who cannot adhere to multilayer compression.
8. Presence of any condition(s) which seriously compromises the subject's ability to complete this study or has a known history of poor adherence with medical treatment.
9. Active treatment of infection anywhere in the body with IV antibiotics, at screening and baseline.
10. Suspected or confirmed signs/symptoms of gangrene on any part of the affected limb.
11. Known Osteomyelitis or bone infection of the affected foot or leg as verified by diagnostic imaging within 30 days prior to enrollment.
12. Subject is pregnant or breast feeding.
13. Study ulcer with a history of treatment with hyperbaric oxygen, growth factors or other biologic treatments, or a Cellular or Tissue-based Product (CTP) within 30 days of enrollment.
14. Subject has a known or suspected allergy to products under study.
15. Pregnancy or breast feeding.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sanara MedTech
UNKNOWN
SerenaGroup, Inc.
NETWORK
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Serens Group Austin Research Center
Austin, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BIAKŌS
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.