NCT06024590

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 6, 2023

Completed
27 days until next milestone

Study Start

First participant enrolled

October 3, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 22, 2025

Completed
Last Updated

July 28, 2025

Status Verified

July 1, 2025

Enrollment Period

1.6 years

First QC Date

August 28, 2023

Last Update Submit

July 24, 2025

Conditions

Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Time: to heal within 12 weeks

    Weekly up to 12 weeks

  • Percent Area Reduction (PAR) at 12 weeks

    Weekly up to 12 weeks

  • Pain reduction between visits, measured by Visual Analogue Scale (VAS)

    Weekly up to 12 weeks

  • Wound complication rate

    Weekly up to 12 weeks

Study Arms (2)

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.

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.

Device: Saline

Interventions

IrriseptDEVICE

Standard of care wound treatment with 150 mL of IrriseptTM irrigation of the wound at each follow up visit.

Group A: irrigation with Irrisept™
SalineDEVICE

Standard of care wound treatment with 150 mL ration of Normal saline irrigation of the wound at each follow up visit

Group B: irrigation or irrigation with normal saline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Northern Illinois Foot & Ankle Specialists

Cary, Illinois, 60013, United States

Location

Northern Illinois Foot & Ankle Specialists

Crystal Lake, Illinois, 60014, United States

Location

Northern Illinois Foot & Ankle Specialists

Elgin, Illinois, 60123, United States

Location

Northern Illinois Foot & Ankle Specialists

Fox Lake, Illinois, 60020, United States

Location

Northern Illinois Foot & Ankle Specialist

Lake in the Hills, Illinois, 60156, United States

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Study Officials

  • Patrick McEneaney, DPM

    Northern Illinois Foot & Ankle Specialist

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2023

First Posted

September 6, 2023

Study Start

October 3, 2023

Primary Completion

May 22, 2025

Study Completion

May 22, 2025

Last Updated

July 28, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

US(5)