search
Back to results

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

Primary Purpose

Diabetic Foot Ulcer

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Irrisept
Saline
Sponsored by
Northern Illinois Foot and Ankle Specialists
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Northern Illinois Foot & Ankle SpecialistsRecruiting
  • Northern Illinois Foot & Ankle SpecialistsRecruiting
  • Northern Illinois Foot & Ankle SpecialistsRecruiting
  • Northern Illinois Foot & Ankle SpecialistsRecruiting
  • Northern Illinois Foot & Ankle SpecialistRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group A: irrigation with Irrisept™

Group B: irrigation or irrigation with normal saline

Arm Description

Group A: standard of care wound treatment with 150 mL of IrriseptTM irrigation of the wound at each follow up visit.

Group B: standard of care wound treatment with 150 mL ration of normal saline irrigation of the wound at each follow up visit.

Outcomes

Primary Outcome Measures

The primary endpoint is the percentage of index ulcers healed at 12 weeks
Percentage of index ulcers healed from baseline up to 12 weeks

Secondary Outcome Measures

Time: to heal within 12 weeks
Days to heal from baseline up to 12 weeks
Percent Area Reduction (PAR) at 12 weeks
Percent Area Reduction (PAR) from baseline 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)
Wound complication rate
Infection, return to operating room for management or other adverse events during the treatment course.

Full Information

First Posted
August 28, 2023
Last Updated
October 19, 2023
Sponsor
Northern Illinois Foot and Ankle Specialists
Collaborators
Irrimax Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT06024590
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 3, 2023 (Actual)
Primary Completion Date
September 25, 2024 (Anticipated)
Study Completion Date
September 25, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northern Illinois Foot and Ankle Specialists
Collaborators
Irrimax Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A: irrigation with Irrisept™
Arm Type
Active Comparator
Arm Description
Group A: standard of care wound treatment with 150 mL of IrriseptTM irrigation of the wound at each follow up visit.
Arm Title
Group B: irrigation or irrigation with normal saline
Arm Type
Active Comparator
Arm Description
Group B: standard of care wound treatment with 150 mL ration of normal saline irrigation of the wound at each follow up visit.
Intervention Type
Device
Intervention Name(s)
Irrisept
Intervention Description
Standard of care wound treatment with 150 mL of IrriseptTM irrigation of the wound at each follow up visit.
Intervention Type
Device
Intervention Name(s)
Saline
Intervention Description
Standard of care wound treatment with 150 mL ration of Normal saline irrigation of the wound at each follow up visit
Primary Outcome Measure Information:
Title
The primary endpoint is the percentage of index ulcers healed at 12 weeks
Description
Percentage of index ulcers healed from baseline up to 12 weeks
Time Frame
Weekly up to 12 weeks
Secondary Outcome Measure Information:
Title
Time: to heal within 12 weeks
Description
Days to heal from baseline up to 12 weeks
Time Frame
Weekly up to 12 weeks
Title
Percent Area Reduction (PAR) at 12 weeks
Description
Percent Area Reduction (PAR) from baseline up to 12 weeks
Time Frame
Weekly up to 12 weeks
Title
Pain reduction between visits, measured by Visual Analogue Scale (VAS)
Description
Pain reduction from baseline up to 12 weeks. VAS (0-100 scale; 0 being no discomfort, 100 being intense discomfort)
Time Frame
Weekly up to 12 weeks
Title
Wound complication rate
Description
Infection, return to operating room for management or other adverse events during the treatment course.
Time Frame
Weekly up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lori Rotolo, BS
Phone
2168493574
Email
lorirotolo@illinoisfoot.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick McEneaney, DPM
Organizational Affiliation
Northern Illinois Foot & Ankle Specialist
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northern Illinois Foot & Ankle Specialists
City
Cary
State/Province
Illinois
ZIP/Postal Code
60013
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lori Rotolo, BS
Email
lorirotolo@Illinoisfoot.com
First Name & Middle Initial & Last Name & Degree
Rimvydas Statkus, DPM
First Name & Middle Initial & Last Name & Degree
Summer Bochat, DPM
First Name & Middle Initial & Last Name & Degree
Peter Lovato, DPM
First Name & Middle Initial & Last Name & Degree
Rebecca Stack, DPM
First Name & Middle Initial & Last Name & Degree
John Thometz, DPM
Facility Name
Northern Illinois Foot & Ankle Specialists
City
Crystal Lake
State/Province
Illinois
ZIP/Postal Code
60014
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lori Rotolo, BS
Phone
216-849-3574
Email
lorirotolo@illinoisfoot.com
First Name & Middle Initial & Last Name & Degree
Patrick McEneaney, DPM
First Name & Middle Initial & Last Name & Degree
Peter Lovato, DPM
First Name & Middle Initial & Last Name & Degree
Kimberly Nolan, DPM
First Name & Middle Initial & Last Name & Degree
Rebecca Stack, DPM
First Name & Middle Initial & Last Name & Degree
Summer Bochat, DPM
First Name & Middle Initial & Last Name & Degree
Rimvydas Statkus, DPM
Facility Name
Northern Illinois Foot & Ankle Specialists
City
Elgin
State/Province
Illinois
ZIP/Postal Code
60123
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lori Rotolo, BS
Email
lorirotolo@illinoisfoot.com
First Name & Middle Initial & Last Name & Degree
John Thometz, DPM
Facility Name
Northern Illinois Foot & Ankle Specialists
City
Fox Lake
State/Province
Illinois
ZIP/Postal Code
60020
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lori Rotolo, BS
Email
lorirotolo@illinoisfoot.com
First Name & Middle Initial & Last Name & Degree
Summer Bochat, DMP
First Name & Middle Initial & Last Name & Degree
Rimvydas Statkus, DPM
Facility Name
Northern Illinois Foot & Ankle Specialist
City
Lake In The Hills
State/Province
Illinois
ZIP/Postal Code
60156
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lori Rotolo, BS
Phone
216-849-3574
Email
lorirotolo@illinoisfoot.com
First Name & Middle Initial & Last Name & Degree
Peter Lovato, DPM
First Name & Middle Initial & Last Name & Degree
Summer Bochat, DPM
First Name & Middle Initial & Last Name & Degree
Rebecca Stack, DPM
First Name & Middle Initial & Last Name & Degree
John Thometz, DPM
First Name & Middle Initial & Last Name & Degree
Rimvydas Statkus, DPM

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs