Outcomes of Irrisept Irrigation as an Adjunctive Treatment in the Management of Diabetic Foot Ulcers

Outcomes of Chlorhexidine Gluconate Irrigation as an Adjunctive Treatment in the Management of Diabetic Foot Ulcers

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Foot Ulcer
• Intervention / Treatment: Device: Irrisept; Device: Saline

Detailed Description

The purpose of this clinical evaluation is to collect patient outcome data on Irrisept™ irrigation. This is a jet irrigation of 0.05% Chlorhexidine Gluconate (CHG) in sterile water delivered under pressure by manual compression of the bottle by the user. This treatment allows for management of bioburden in a wound through broad spectrum antimicrobial activity by the CHG as well as removal of debris from the wound bed.

In this trial, participants with partial and full thickness diabetic foot ulcers (DFUs) - 'full skin thickness and extending through the subcutaneous or fat layers or to deeper structures such as tendon and fascia will receive standard of care treatment with indicated off-loading device (SOC) for their condition in addition to wound bed irrigation with Irrisept™ or saline Irrigation.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Cary, Illinois, United States, 60013
      • Northern Illinois Foot & Ankle Specialists
    • Crystal Lake, Illinois, United States, 60014
      • Northern Illinois Foot & Ankle Specialists
    • Elgin, Illinois, United States, 60123
      • Northern Illinois Foot & Ankle Specialists
    • Fox Lake, Illinois, United States, 60020
      • Northern Illinois Foot & Ankle Specialists
    • Lake In The Hills, Illinois, United States, 60156
      • Northern Illinois Foot & Ankle Specialist

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A: irrigation with Irrisept™; Group A: standard of care wound treatment with 150 mL of IrriseptTM irrigation of the wound at each follow up visit.	Device: Irrisept; Standard of care wound treatment with 150 mL of IrriseptTM irrigation of the wound at each follow up visit.
Active Comparator: Group B: irrigation or irrigation with normal saline; Group B: standard of care wound treatment with 150 mL ration of normal saline irrigation of the wound at each follow up visit.	Device: Saline; Standard of care wound treatment with 150 mL ration of Normal saline irrigation of the wound at each follow up visit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary endpoint is the percentage of index ulcers healed at 12 weeks	Percentage of index ulcers healed from baseline up to 12 weeks	Weekly up to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time: to heal within 12 weeks	Days to heal from baseline up to 12 weeks	Weekly up to 12 weeks
Percent Area Reduction (PAR) at 12 weeks	Percent Area Reduction (PAR) from baseline up to 12 weeks	Weekly up to 12 weeks
Pain reduction between visits, measured by Visual Analogue Scale (VAS)	Pain reduction from baseline up to 12 weeks. VAS (0-100 scale; 0 being no discomfort, 100 being intense discomfort)	Weekly up to 12 weeks
Wound complication rate	Infection, return to operating room for management or other adverse events during the treatment course.	Weekly up to 12 weeks

Collaborators and Investigators

• Sponsor: Northern Illinois Foot and Ankle Specialists
• Collaborators: Irrimax Corporation
• Investigators: Principal Investigator: Patrick McEneaney, DPM, Northern Illinois Foot & Ankle Specialist

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2023
• Primary Completion (Actual): May 22, 2025
• Study Completion (Actual): May 22, 2025

Study Registration Dates

• First Submitted: August 28, 2023
• First Submitted That Met QC Criteria: September 1, 2023
• First Posted (Actual): September 6, 2023

Study Record Updates

• Last Update Posted (Actual): July 28, 2025
• Last Update Submitted That Met QC Criteria: July 24, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Diabetes Mellitus; Diabetic Angiopathies; Diabetes Complications; Skin Diseases; Skin Ulcer; Leg Ulcer; Diabetic Neuropathies; Foot Diseases; Ulcer; Diabetic Foot; Foot Ulcer
• Other Study ID Numbers: NIFAS-2023-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No