Diabetic Foot UlcerNCT06024590
Outcomes of Irrisept Irrigation as an Adjunctive Treatment in the Management of Diabetic Foot Ulcers
A study testing Irrisept and Saline in people with Diabetic Foot Ulcer, run by Northern Illinois Foot and Ankle Specialists at 5 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Irrisept and Saline
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 5 sitesUnited States
- Study dates
- 3 Oct 2023to 22 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Northern Illinois Foot & Ankle Specialists
Cary, Illinois, 60013
Northern Illinois Foot & Ankle Specialists
Crystal Lake, Illinois, 60014
Northern Illinois Foot & Ankle Specialists
Elgin, Illinois, 60123
Northern Illinois Foot & Ankle Specialists
Fox Lake, Illinois, 60020
Northern Illinois Foot & Ankle Specialist
Lake in the Hills, Illinois, 60156
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Irrisept, Saline
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IrriseptDevice
Standard of care wound treatment with 150 mL of IrriseptTM irrigation of the wound at each follow up visit.
SalineDevice
Standard of care wound treatment with 150 mL ration of Normal saline irrigation of the wound at each follow up visit
| Study group | Role | What they receive |
|---|---|---|
| Group A: irrigation with Irrisept™ | Active comparator | Group A: standard of care wound treatment with 150 mL of IrriseptTM irrigation of the wound at each follow up visit. Receives: Device: Irrisept |
| Group B: irrigation or irrigation with normal saline | Active comparator | Group B: standard of care wound treatment with 150 mL ration of normal saline irrigation of the wound at each follow up visit. Receives: Device: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the percentage of index ulcers healed at 12 weeks
Percentage of index ulcers healed from baseline up to 12 weeks
Measured: Weekly up to 12 weeks
Secondary outcomes (4)
Time: to heal within 12 weeks
Days to heal from baseline up to 12 weeks
Measured: Weekly up to 12 weeks
Percent Area Reduction (PAR) at 12 weeks
Percent Area Reduction (PAR) from baseline up to 12 weeks
Measured: 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)
Measured: Weekly up to 12 weeks
Wound complication rate
Infection, return to operating room for management or other adverse events during the treatment course.
Measured: Weekly up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start3 Oct 2023
- Primary completion22 May 2025
- Study completion22 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern Illinois Foot and Ankle Specialists
- Sponsor type
- University, hospital or other
- Collaborators
- Irrimax Corporation
- Responsible party
- Sponsor
- Investigators
- Patrick McEneaney, DPM, Principal investigator, Northern Illinois Foot & Ankle Specialist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06024590
- Sponsor's protocol ID
- NIFAS-2023-001
- Status last verified
- Jul 2025
- First submitted
- 28 Aug 2023
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Chlorhexidine Gluconate Irrigation as an Adjunctive Treatment in the Management of Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT06024590
- Acronym / sponsor ID
- NIFAS-2023-001
- Conditions
- Diabetic Foot Ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Northern Illinois Foot and Ankle SpecialistsUniversity, hospital or other
- Collaborators
- Irrimax Corporation
- Study start
- 3 Oct 2023 (actual)
- Primary completion
- 22 May 2025 (actual)
- Study completion
- 22 May 2025 (actual)
- First posted
- 6 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: irrigation with Irrisept™ | Active comparator | Device: IrriseptGroup A: standard of care wound treatment with 150 mL of IrriseptTM irrigation of the wound at each follow up visit. |
| Group B: irrigation or irrigation with normal saline | Active comparator | Device: SalineGroup B: standard of care wound treatment with 150 mL ration of normal saline irrigation of the wound at each follow up visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IrriseptStandard of care wound treatment with 150 mL of IrriseptTM irrigation of the wound at each follow up visit. | Device | Group A: irrigation with Irrisept™ |
| SalineStandard of care wound treatment with 150 mL ration of Normal saline irrigation of the wound at each follow up visit | Device | Group B: irrigation or irrigation with normal saline |
Primary outcome
The primary endpoint is the percentage of index ulcers healed at 12 weeks
Time frame: Weekly up to 12 weeks
Percentage of index ulcers healed from baseline up to 12 weeks
4 secondary outcomes
Time: to heal within 12 weeks
Time frame: Weekly up to 12 weeks
Percent Area Reduction (PAR) at 12 weeks
Time frame: Weekly up to 12 weeks
Pain reduction between visits, measured by Visual Analogue Scale (VAS)
Time frame: Weekly up to 12 weeks
Wound complication rate
Time frame: Weekly up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Diabetic Foot Ulcer
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Diabetes, Peripheral Neuropathy
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
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Better Care Closer to Home: Enhancing Primary and Community Care
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick McEneaney, DPM principal investigator
Northern Illinois Foot & Ankle Specialist
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Irrisept and Saline in people with Diabetic Foot Ulcer, run by Northern Illinois Foot and Ankle Specialists at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint is the percentage of index ulcers healed at 12 weeks (time frame: Weekly up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.