Using Irrisept irrigation to treat diabetic foot ulcers
Outcomes of Chlorhexidine Gluconate Irrigation as an Adjunctive Treatment in the Management of Diabetic Foot Ulcers
This study is testing if using Irrisept™ irrigation can help heal diabetic foot ulcers better than regular saline irrigation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Northern Illinois Foot and Ankle Specialists Academic / other |
| Locations | 5 sites (Cary, Illinois and 4 other locations) |
| Trial ID | NCT06024590 on ClinicalTrials.gov |
What this trial studies
This clinical evaluation aims to assess the effectiveness of Irrisept™ irrigation, which contains 0.05% Chlorhexidine Gluconate (CHG), in managing diabetic foot ulcers (DFUs). Participants with partial and full thickness DFUs will receive standard care along with either Irrisept™ or saline irrigation to compare outcomes. The study focuses on the ability of Irrisept™ to reduce bacterial load and improve wound healing through its antimicrobial properties and debris removal capabilities.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with partial or full thickness diabetic foot ulcers that have been present for more than 4 weeks but less than 1 year.
Not a fit: Patients with wounds located on the heel or those without adequate circulation to the affected foot may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly enhance healing rates for patients with diabetic foot ulcers.
How similar studies have performed: While the specific use of Irrisept™ is novel, similar studies have shown that enhanced irrigation techniques can improve outcomes in wound management.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Cary, Illinois and 4 other locations
- Northern Illinois Foot & Ankle Specialists — Cary, Illinois, United States (Recruiting)
- Northern Illinois Foot & Ankle Specialists — Crystal Lake, Illinois, United States (Recruiting)
- Northern Illinois Foot & Ankle Specialists — Elgin, Illinois, United States (Recruiting)
- Northern Illinois Foot & Ankle Specialists — Fox Lake, Illinois, United States (Recruiting)
- Northern Illinois Foot & Ankle Specialist — Lake In The Hills, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Patrick McEneaney, DPM — Northern Illinois Foot & Ankle Specialist
- Study coordinator: Lori Rotolo, BS
- Email: lorirotolo@illinoisfoot.com
- Phone: 2168493574
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.