Clinical trial NCT06024590: Outcomes of Irrisept Irrigation as an Adjunctive Treatment in the Management of Diabetic Foot Ulcers
Official title: Outcomes of Chlorhexidine Gluconate Irrigation as an Adjunctive Treatment in the Management of Diabetic Foot Ulcers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetic Foot Ulcer
Lead sponsor: Northern Illinois Foot and Ankle Specialists
Sponsor class: OTHER
Collaborators: name: Irrimax Corporation
First posted: 2023-09-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The primary endpoint is the percentage of index ulcers healed at 12 weeks
timeFrame: Weekly up to 12 weeks
Secondary outcomes:
measure: Time: to heal within 12 weeks
timeFrame: Weekly up to 12 weeks
measure: Percent Area Reduction (PAR) at 12 weeks
timeFrame: Weekly up to 12 weeks
measure: Pain reduction between visits, measured by Visual Analogue Scale (VAS)
timeFrame: Weekly up to 12 weeks
measure: Wound complication rate
timeFrame: Weekly up to 12 weeks
Other outcomes:
Locations:
city: Cary
country: United States
facility: Northern Illinois Foot & Ankle Specialists
state: Illinois
city: Crystal Lake
country: United States
facility: Northern Illinois Foot & Ankle Specialists
state: Illinois
city: Elgin
country: United States
facility: Northern Illinois Foot & Ankle Specialists
state: Illinois
city: Fox Lake
country: United States
facility: Northern Illinois Foot & Ankle Specialists
state: Illinois
city: Lake In The Hills
country: United States
facility: Northern Illinois Foot & Ankle Specialist
state: Illinois
Study officials:
affiliation: Northern Illinois Foot & Ankle Specialist
name: Patrick McEneaney, DPM
role: PRINCIPAL_INVESTIGATOR
References: