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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weekly up to 12 weeks
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 below
Select...
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weekly up to 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and weekly up to 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The primary endpoint is the percentage of index ulcers healed at 12 weeks
Secondary outcome measures
Pain reduction between visits, measured by Visual Analogue Scale (VAS)
Percent Area Reduction (PAR) at 12 weeks
Time: to heal within 12 weeks
+1 more

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.

Find a Location

Who is running the clinical trial?

Irrimax CorporationIndustry Sponsor
9 Previous Clinical Trials
2,047 Total Patients Enrolled
Northern Illinois Foot and Ankle SpecialistsLead Sponsor
Patrick McEneaney, DPMPrincipal InvestigatorNorthern Illinois Foot & Ankle Specialist

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there availability for enrolment in this trial?

"Affirmative. Clinicaltrials.gov demonstrates that this clinical trial, which was published on September 25th 2023 is currently accepting participants. 30 patients are needed to join the study at 5 distinct medical facilities."

Answered by AI

What is the enrollment size of this clinical trial?

"Affirmative. According to clinicaltrials.gov, the search for participants is still underway since this medical trial was first posted on September 25th 2023 and most recently edited on September 15th 2023. A total of 30 individuals are needed from 5 different sites."

Answered by AI

How many places are currently managing this research endeavor?

"Currently, 5 medical centres are recruiting for this trial. These locations can be found in and around Crystal Lake, Elgin, Fox Lake and a few other cities. Thus it is prudent to choose the closest clinic to minimise travel needs if you decide to participate."

Answered by AI

Has the administration granted approval to irrigate with Irrisept™ for Group A?

"Considering the Phase 4 status of Group A: irrigation with Irrisept™, it is considered highly safe and thus was rated a 3."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Outcomes of Irrisept Irrigation as an Adjunctive Treatment in the Management of Diabetic Foot Ulcers
2023. "Outcomes of Irrisept Irrigation as an Adjunctive Treatment in the Management of Diabetic Foot Ulcers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06024590.
~11 spots leftby Sep 2024
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