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

Diabetic Foot Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06024590
• Other study ID #: NIFAS-2023-001
• Status: Recruiting
• Phase: Phase 4
• Start date: October 3, 2023
• Est. completion date: September 25, 2024

Study information

• Verified date: October 2023
• Source: Northern Illinois Foot and Ankle Specialists
• Contact: Lori Rotolo, BS
• Phone: 2168493574
• Email: lorirotolo[@]illinoisfoot.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 25, 2024
• Est. primary completion date: September 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

Intervention

Device:
• Irrisept
Standard of care wound treatment with 150 mL of IrriseptTM irrigation of the wound at each follow up visit.
• Saline
Standard of care wound treatment with 150 mL ration of Normal saline irrigation of the wound at each follow up visit

Locations

Country	Name	City	State
United States	Northern Illinois Foot & Ankle Specialists	Cary	Illinois
United States	Northern Illinois Foot & Ankle Specialists	Crystal Lake	Illinois
United States	Northern Illinois Foot & Ankle Specialists	Elgin	Illinois
United States	Northern Illinois Foot & Ankle Specialists	Fox Lake	Illinois
United States	Northern Illinois Foot & Ankle Specialist	Lake In The Hills	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northern Illinois Foot and Ankle Specialists	Irrimax Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time: to heal within 12 weeks	Days to heal from baseline up to 12 weeks	Weekly up to 12 weeks
Secondary	Percent Area Reduction (PAR) at 12 weeks	Percent Area Reduction (PAR) from baseline up to 12 weeks	Weekly up to 12 weeks
Secondary	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
Secondary	Wound complication rate	Infection, return to operating room for management or other adverse events during the treatment course.	Weekly up to 12 weeks