Status:
COMPLETED
Outcomes of Irrisept Irrigation as an Adjunctive Treatment in the Management of Diabetic Foot Ulcers
Lead Sponsor:
Northern Illinois Foot and Ankle Specialists
Collaborating Sponsors:
Irrimax Corporation
Conditions:
Diabetic Foot Ulcer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Irrisept™ irrigation containing Chlorhexidine Gluconate (CHG) 0.05% in sterile water, is an irrigation method that may help reduce bacterial load considerably more than traditional saline irrigation.
Detailed Description
The purpose of this clinical evaluation is to collect patient outcome data on Irrisept™ irrigation. This is a jet irrigation of 0.05% Chlorhexidine Gluconate (CHG) in sterile water delivered under pre...
Eligibility Criteria
Inclusion
- At least 18 years old.
- Presence of a partial and full thickness DFU extending at least through the dermis and into the subcutaneous tissue down to the exposed tendon and fascia.
- Wounds present anatomically on the foot as defined by beginning below the malleoli of the ankle, excluding wounds on the heel.
- The index ulcer will be the largest ulcer if two or more eligible DFUs are present and will be the only one evaluated in the study. If other ulcerations are present on the same foot, they must be more than 2 cm distant from the index ulcer.
- Index ulcer (i.e., current episode of ulceration) has been present for greater than 4 weeks prior to first screening visit (SV1) and less than 1 year, as of the date the subject consents for study.
- Adequate circulation to the affected foot as documented by the following: palpable pedal pulses, pulses audibly biphasic or triphasic with handheld doppler, or recent (\<6 month) vascular testing (both invasive \& non-invasive).
- Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers or abstinence) during the course of the study and undergo pregnancy tests.
- Subject understands and is willing to participate in the clinical study and can comply with weekly visits.
- Subject understands they can exit the study at any time.
Exclusion
- Clinical signs of infection at the start of the study
- Exposed bone(s)
- Immunocompromised as determined by treating physician
- Presence of greater than one full-thickness DFU less than 2 cm apart
Key Trial Info
Start Date :
October 3 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 22 2025
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT06024590
Start Date
October 3 2023
End Date
May 22 2025
Last Update
July 28 2025
Active Locations (5)
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1
Northern Illinois Foot & Ankle Specialists
Cary, Illinois, United States, 60013
2
Northern Illinois Foot & Ankle Specialists
Crystal Lake, Illinois, United States, 60014
3
Northern Illinois Foot & Ankle Specialists
Elgin, Illinois, United States, 60123
4
Northern Illinois Foot & Ankle Specialists
Fox Lake, Illinois, United States, 60020