NCT06024590

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Northern Illinois Foot and Ankle Specialists · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
DEVICE	Irrisept	Standard of care wound treatment with 150 mL of IrriseptTM irrigation of the wound at each follow up visit.
DEVICE	Saline	Standard of care wound treatment with 150 mL ration of Normal saline irrigation of the wound at each follow up visit

Timeline

• Start date: 2023-10-03
• Primary completion: 2025-05-22
• Completion: 2025-05-22
• First posted: 2023-09-06
• Last updated: 2025-07-28

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study