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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetic Foot Ulcer

Intervention / Treatment
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* Device: Irrisept
* Device: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years old. 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. Wounds present anatomically on the foot as defined by beginning below the malleoli of the ankle, excluding wounds on the heel. 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. 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. 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). 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. Subject understands and is willing to participate in the clinical study and can comply with weekly visits. Subject understands they can exit the study at any time. Exclusion Criteria: Clinical signs of infection at the start of the study Exposed bone(s) Immunocompromised as determined by treating physician Presence of greater than one full-thickness DFU less than 2 cm apart

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |