Irrisept Irrigation for Diabetic Foot Ulcers

Recruiting at 4 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

30 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Irrisept Irrigation for Diabetic Foot Ulcers?

The research does not provide direct evidence for the effectiveness of Irrisept Irrigation for Diabetic Foot Ulcers, but it mentions that negative pressure wound therapy combined with a lavage system can be effective for treating severe diabetic foot ulcers with infections. ^{1 2 3 4 5}

How does the Irrisept treatment for diabetic foot ulcers differ from other treatments?

Irrisept irrigation is unique because it involves a lavage system (a method of washing out a wound) that can be combined with negative pressure wound therapy, which helps remove infectious material and promote healing. This approach is different from standard antiseptic solutions or antibiotic treatments, as it physically cleanses the wound while also applying suction to enhance healing. ^{1 2 6 7 8}

What is the purpose of this trial?

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.

Research Team

Patrick McEneaney, DPM

Principal Investigator

Northern Illinois Foot & Ankle Specialist

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. China pubmed.ncbi.nlm.nih.gov

[Comparative Analysis of Clinical Efficacy of Negative Pressure Wound Therapy Plus Lavage System in the Treatment of Wagner Grade 3-5 Diabetic Foot Ulcers Combined with Infection]. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

A randomized controlled trial to examine the efficacy and safety of a new super-oxidized solution for the management of wide postsurgical lesions of the diabetic foot. [2017]

3. United States pubmed.ncbi.nlm.nih.gov

Treatment of osteomyelitis in the feet of diabetic patients by photodynamic antimicrobial chemotherapy. [2010]

4. England pubmed.ncbi.nlm.nih.gov

Effectiveness of interventions to enhance healing of chronic ulcers of the foot in diabetes: a systematic review. [2021]

5. England pubmed.ncbi.nlm.nih.gov

A systematic review of interventions to enhance the healing of chronic ulcers of the foot in diabetes. [2022]

6. China pubmed.ncbi.nlm.nih.gov

[A comparative study on effect of bacterial load in diabetic foot ulcers dealing with iodophor and rivanol respectively]. [2013]

7. United States pubmed.ncbi.nlm.nih.gov

Neutralizing Staphylococcus aureus Virulence with AZD6389, a Three mAb Combination, Accelerates Closure of a Diabetic Polymicrobial Wound. [2022]

8. Brazil pubmed.ncbi.nlm.nih.gov

Interventions for wound healing among diabetic patients infected with Staphylococcus aureus: a systematic review. [2019]