COMPLETED

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

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-10-03

Study Completion:2025-05-22

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06024590

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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

Inclusion Criteria

Exclusion 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.

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

Contacts and Locations

Principal Investigator

Patrick McEneaney, DPM

PRINCIPAL_INVESTIGATOR

Northern Illinois Foot & Ankle Specialist

Study Locations (Sites)

Northern Illinois Foot & Ankle Specialists

Cary, Illinois, 60013

United States

Northern Illinois Foot & Ankle Specialists

Crystal Lake, Illinois, 60014

United States

Northern Illinois Foot & Ankle Specialists

Elgin, Illinois, 60123

United States

Northern Illinois Foot & Ankle Specialists

Fox Lake, Illinois, 60020

United States

Northern Illinois Foot & Ankle Specialist

Lake In The Hills, Illinois, 60156

United States

Collaborators and Investigators

Sponsor: Northern Illinois Foot and Ankle Specialists

Patrick McEneaney, DPM, PRINCIPAL_INVESTIGATOR, Northern Illinois Foot & Ankle Specialist

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-03

Study Completion Date2025-05-22

Study Record Updates

Study Start Date2023-10-03

Study Completion Date2025-05-22

Terms related to this study

Additional Relevant MeSH Terms

Diabetic Foot Ulcer