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

Completed · Not applicable

Conditions studied: Diabetic Foot Ulcer

In brief

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.

Key facts

Study ID

NCT06024590

Run by

Northern Illinois Foot and Ankle Specialists

People needed

9

Starts

2023-10-03

Expected to finish

2025-05-22

Last updated by the study team

2025-07-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Northern Illinois Foot & Ankle Specialists — Cary, Illinois, United States
• Northern Illinois Foot & Ankle Specialists — Crystal Lake, Illinois, United States
• Northern Illinois Foot & Ankle Specialists — Elgin, Illinois, United States
• Northern Illinois Foot & Ankle Specialists — Fox Lake, Illinois, United States
• Northern Illinois Foot & Ankle Specialist — Lake in the Hills, Illinois, United States

Full record on ClinicalTrials.gov

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