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Irrisept Irrigation for Diabetic Foot Ulcers
Phase 4
Recruiting
Led By Patrick McEneaney, DPM
Research Sponsored by Northern Illinois Foot and Ankle Specialists
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Wounds present anatomically on the foot as defined by beginning below the malleoli of the ankle, excluding wounds on the heel
At least 18 years old
Must not have
Clinical signs of infection at the start of the study
Presence of greater than one full-thickness DFU less than 2 cm apart
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weekly up to 12 weeks
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial suggests a new irrigation method using CHG may help reduce bacteria in wounds more than traditional saline irrigation.
Who is the study for?
This trial is for adults over 18 with diabetic foot ulcers extending through the skin into subcutaneous tissue, but not on heels or with exposed bones. Ulcers must be present for 4 weeks to less than a year and located more than 2 cm apart if multiple. Participants need good blood flow in the affected foot and women of childbearing age should use contraception.
What is being tested?
The study compares Irrisept irrigation, which includes Chlorhexidine Gluconate (CHG), against traditional saline irrigation to see if it better reduces bacterial load in diabetic foot ulcers.
What are the potential side effects?
Potential side effects may include local skin reactions like irritation or allergic responses due to CHG exposure during Irrisept treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have wounds on my foot, not including the heel, starting below the ankle bone.
Select...
I am 18 years old or older.
Select...
My foot ulcer extends through the skin to the tendon.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have signs of infection at the start of the study.
Select...
I have more than one deep foot ulcer close together.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weekly up to 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weekly up to 12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The primary endpoint is the percentage of index ulcers healed at 12 weeks
Secondary study objectives
Pain reduction between visits, measured by Visual Analogue Scale (VAS)
Percent Area Reduction (PAR) at 12 weeks
Time: to heal within 12 weeks
+1 moreAwards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Active Control
Group I: Group A: irrigation with Irrisept™Active Control1 Intervention
Group A: standard of care wound treatment with 150 mL of IrriseptTM irrigation of the wound at each follow up visit.
Group II: Group B: irrigation or irrigation with normal salineActive Control1 Intervention
Group B: standard of care wound treatment with 150 mL ration of normal saline irrigation of the wound at each follow up visit.
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Who is running the clinical trial?
Northern Illinois Foot and Ankle SpecialistsLead Sponsor
Irrimax CorporationIndustry Sponsor
9 Previous Clinical Trials
2,047 Total Patients Enrolled
Patrick McEneaney, DPMPrincipal InvestigatorNorthern Illinois Foot & Ankle Specialist
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