Status:
COMPLETED
Activated Carbon Interphase Effect on Biofilm and Total Bacterial Load
Lead Sponsor:
Brock Liden, DPM
Conditions:
Wound Infection
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this randomized, prospective study is to evaluate how this activated carbon dressing affects the total bacterial load and biofilm in a wound bed in wounds of the lower extremity and foo...
Detailed Description
Wounds located on the lower extremity and feet are caused by several conditions, including diabetes and venous insufficiency. These types of wounds may not heal quickly and can become chronic. Chronic...
Eligibility Criteria
Inclusion
- Patients who are at least 18 years of age.
- Patients of both genders and all races.
- Patients who are in good general health.
- Patients with ankle-brachial index (ABI) measurements greater than 0.5.
- Patients with full-thickness lower extremity diabetic or venous wounds that are not currently being treated with antimicrobial products.
- Patients with full-thickness wounds that are not yet extending to the bone or tendon.
- Patients with wounds present for at least 4 weeks, but no longer than one year.
- Patients with initial bacterial load greater than or equal to 104 colony forming units (CFUs), but less than or equal to 106 CFUs.
- Patients who have voluntarily signed the informed consent form, including HIPAA Authorization.
Exclusion
- Patients who are younger than 18 years of age.
- Patients with autoimmune conditions.
- Patients with ABI measurements less than 0.5 or with lower extremities that are non-interventional or by-passable.
- Patients with full-thickness lower extremity pressure wounds.
- Patients with diabetic or venous wounds that are being treated with antimicrobial products.
- Patients with full-thickness wounds with exposed bone or tendon.
- Patients with wounds present less than 4 weeks or one year or longer.
- Patients with ulcers that had an initial bacterial load less than 104 CFUs or greater than 106 CFUs.
- Patients who are pregnant or lactating.
- Patients with known allergy(ies) to any of the components of the study dressing.
- Patients who are considered by the investigator for any reason to be an unsuitable candidate.
- Patients who are unwilling or unable to follow the follow-up evaluation schedules.
- Patients who refuse to voluntarily sign the informed consent form.
Key Trial Info
Start Date :
June 26 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2019
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT03461783
Start Date
June 26 2017
End Date
February 1 2019
Last Update
February 27 2019
Active Locations (2)
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1
Circleville Foot & Ankle, LLC
Circleville, Ohio, United States, 43113
2
Hocking Valley Community Hospital
Logan, Ohio, United States, 43138