Irrisept Irrigation for Diabetic Foot Ulcers

No longer recruiting at 5 trial locations

Overseen By Lori Rotolo, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northern Illinois Foot and Ankle Specialists

Disqualifiers: Infection, Exposed bone, Immunocompromised, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to clean diabetic foot ulcers using Irrisept, which contains a special solution with Chlorhexidine Gluconate (CHG) that may reduce bacteria more effectively than regular saline. Participants will have their wounds cleaned with either Irrisept or normal saline to compare results. The trial targets individuals with diabetic foot ulcers present for more than four weeks but less than a year, provided the wound is on the foot and not the heel. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance wound care for diabetic foot ulcers.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this irrigation method is safe for diabetic foot ulcers?

Research has shown that Irrisept, containing 0.05% Chlorhexidine Gluconate (CHG), is very safe to use. It has undergone testing both in the lab and on living beings. Well-organized studies provide evidence supporting its safety. With over 12 years of use, its trustworthiness is well-established.

For those considering a trial involving Irrisept, its history of being well-tolerated offers reassurance. The treatment aims to reduce bacteria in wounds more effectively than regular saltwater solutions, and safety studies support its use for this purpose. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for diabetic foot ulcers involve standard wound care practices, including cleaning with normal saline. However, Irrisept is unique because it uses a specialized irrigation solution that contains chlorhexidine gluconate, which is known for its antimicrobial properties. This could potentially offer a more effective way to reduce bacterial load in wounds, promoting faster healing and reducing the risk of infection. Researchers are excited about Irrisept because it might enhance wound cleaning by actively targeting bacteria, offering a promising alternative to the usual saline irrigation.

What evidence suggests that Irrisept irrigation is effective for diabetic foot ulcers?

Research has shown that Irrisept irrigation, containing 0.05% Chlorhexidine Gluconate (CHG), effectively reduces bacteria in wounds. Studies have found that CHG possesses strong germ-fighting abilities, killing or inhibiting bacterial growth. Although direct evidence for diabetic foot ulcers is not yet available, similar irrigation methods have been successfully applied in other wound care types. CHG is known to lower infection rates, which is crucial for healing wounds like diabetic foot ulcers. In this trial, participants in Group A will receive Irrisept irrigation, while those in Group B will receive normal saline irrigation. This setup suggests that Irrisept might be more effective than traditional saline irrigation. ^{1 2 3 6 7}

Who Is on the Research Team?

Patrick McEneaney, DPM

Principal Investigator

Northern Illinois Foot & Ankle Specialist

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have wounds on my foot, not including the heel, starting below the ankle bone.

My affected foot has good blood flow, confirmed by tests or physical checks.

My current ulcer has been present for more than 4 weeks but less than a year.

Exclusion Criteria

Your immune system is not working well, as decided by your doctor.

Your bone is visible or exposed.

I do not have signs of infection at the start of the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard of care treatment with wound bed irrigation using either Irrisept™ or saline for 12 weeks

12 weeks

Weekly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Irrisept

Trial Overview 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.

How Is the Trial Designed?

Group I: Group A: irrigation with Irrisept™ Active Control 1 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 saline Active Control 1 Intervention

Group B: standard of care wound treatment with 150 mL ration of normal saline irrigation of the wound at each follow up visit.

Who Is Running the Clinical Trial?

Northern Illinois Foot and Ankle Specialists

Lead Sponsor

Trials

1

Recruited

30+

Irrimax Corporation

Industry Sponsor

Trials

11

Recruited

2,100+

Citations

1. withpower.com withpower.com/trial/phase-4-diabetic-foot-8-2023-79297

Irrisept Irrigation for Diabetic Foot Ulcers · Info for Participants The research does not provide direct evidence for the effectiveness of Irrisept Irrigation for Diabetic Foot Ulcers, but it mentions that negative pressure ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06024590/outcomes-of-irrisept-irrigation-as-an-adjunctive-treatment-in-the-management-of-diabetic-foot-ulcers?state=IL&city=Cary

Outcomes of Irrisept Irrigation as an Adjunctive Treatment ... The purpose of this clinical evaluation is to collect patient outcome data on Irrisept™ irrigation. This is a jet irrigation of 0.05% ...

3. irrisept.com irrisept.com/

Irrisept: Home Irrisept antimicrobial wound lavage is a self-contained jet lavage with low concentration CHG as a preservative in the bottled solution.

4. trial.medpath.com trial.medpath.com/clinical-trial/fa088e72e093cdcd/nct06024590-outcomes-chlorhexidine-gluconate-irrigation-diabetic-foot-ulcers

Outcomes of Irrisept Irrigation as an Adjunctive Treatment in ... The purpose of this clinical evaluation is to collect patient outcome data on Irrisept™ irrigation. This is a jet irrigation of 0.05% Chlorhexidine ...

5. jshoulderelbow.org jshoulderelbow.org/article/S1058-2746(24)00841-3/fulltext

Effect of antiseptic irrigation with 0.05% chlorhexidine ... This study was designed to investigate whether intraoperative Irrisept irrigation would result in a lower positive culture rate of C. acnes vs. standard ...

6. irrisept.com irrisept.com/research/

Research Irrisept features an extensive safety profile with in-vitro and in-vivo studies and RCT data, with >12 years of proven history and testing.

7. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT06024590?keyword=%22Diabetic%20Foot%20Ulcer%22

Outcomes of Irrisept Irrigation as an Adjunctive Treatment ... The purpose of this clinical evaluation is to collect patient outcome data on Irrisept™ irrigation. This is a jet irrigation of 0.05% Chlorhexidine ...