Outcomes of Irrisept Irrigation as an Adjunctive Treatment in the Management of Diabetic Foot Ulcers

Launched by NORTHERN ILLINOIS FOOT AND ANKLE SPECIALISTS · Sep 1, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment method for diabetic foot ulcers (DFUs) using a special irrigation solution called Irrisept™. This solution contains a small amount of Chlorhexidine Gluconate, which is a disinfectant that may help reduce bacteria more effectively than regular saline water. The goal is to see if using this irrigation method can help heal DFUs better than traditional treatments.

To be eligible for this study, participants must be at least 18 years old and have a specific type of diabetic foot ulcer that has been present for over four weeks but less than a year. The ulcer should not be located on the heel and must be the largest one if there are multiple ulcers on the same foot. Participants will need to attend weekly visits for treatment and check-ups but can leave the study at any time if they choose. It’s important to note that anyone with signs of infection or certain health conditions will not be able to participate. This study is currently recruiting and welcomes all genders.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. At least 18 years old.
• • 2. 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.
• • 3. Wounds present anatomically on the foot as defined by beginning below the malleoli of the ankle, excluding wounds on the heel.
• • 4. 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.
• • 5. 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.
• • 6. 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).
• • 7. 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.
• • 8. Subject understands and is willing to participate in the clinical study and can comply with weekly visits.
• • 9. Subject understands they can exit the study at any time.
• Exclusion Criteria:
• • 1. Clinical signs of infection at the start of the study
• • 2. Exposed bone(s)
• • 3. Immunocompromised as determined by treating physician
• • 4. Presence of greater than one full-thickness DFU less than 2 cm apart