Clinical Trials Logo

Clinical 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT06024590
Study type Interventional
Source Northern Illinois Foot and Ankle Specialists
Contact Lori Rotolo, BS
Phone 2168493574
Email lorirotolo@illinoisfoot.com
Status Recruiting
Phase Phase 4
Start date October 3, 2023
Completion date September 25, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT04497805 - Clinical Study of ALLO-ASC-SHEET in Subjects With Diabetic Wagner Grade II Foot Ulcers Phase 2
Withdrawn NCT03675269 - Adjunctive Hyperbaric Oxygen Therapy (HBOT) for Lower Extermity Diabetic Ulcer: N/A
Completed NCT04624516 - Effect of Self-foot Exercise on the Incidence of Plantar Foot Diabetic Ulcer Recurrence N/A
Not yet recruiting NCT06439667 - VIRTUALLY SUPERVISED TELE-EXERCISE PLATFORM FOR ACCELERATING PLANTAR WOUND HEALING
Recruiting NCT05608187 - Evaluating Safety and Biological Effect on Wound Healing of ILP100-Topical in Subjects With Diabetic Foot Ulcers Phase 2
Not yet recruiting NCT06278935 - Lifestyle Tailored Offloading for Diabetic Foot Ulcers N/A
Not yet recruiting NCT06437028 - Evaluating the Efficacy of Perinatal Membrane Allografts for the Treatment of Diabetic Foot Ulcers. N/A
Withdrawn NCT05024656 - AmnioExcel® Plus vs SOC in the Management of Diabetic Foot Ulcers N/A
Terminated NCT02202668 - Transcutaneous Raman Spectroscope (TRS) Analyses of Diabetic Foot Ulcers N/A
Terminated NCT01966380 - Proof of Concept (Design Validation) in Patient With Hard to Heal Wounds Such as Pressure Ulcer, Diabetic Foot Ulcer and Leg Ulcer, Leia Phase 2
Completed NCT01951768 - Efficacy and Safety of Garamycin® Sponge in Diabetic Patients With a Moderate or Severe Foot Ulcer Infection Phase 4
Completed NCT01657474 - Comparative Study of Two Application Regimens of Amniotic Membrane Wound Graft In the Management of Diabetic Foot Ulcers N/A
Active, not recruiting NCT00389636 - TheraGauze™ Alone and Regranex®Gel 0.01% Plus TheraGauze™ in the Treatment of Wagner Stage I Diabetic Foot Ulcers N/A
Completed NCT01181440 - Dermagraft(R) for the Treatment of Patients With Diabetic Foot Ulcers Phase 3
Enrolling by invitation NCT05888259 - Plantar Pressure Distribution in Diabetic Foot Ulcer N/A
Completed NCT04054804 - Digital Foot Check by Using the D-Foot, a New Software
Not yet recruiting NCT05877378 - Efficacy of PICO Single-use System in Chronic Ulcers N/A
Recruiting NCT06037369 - The Short Message-based Customized Standardized N/A
Completed NCT03312595 - Clinical Outcomes After Treatment With RestrataTM Wound Matrix in Diabetic Foot Ulcers (DFU) N/A
Recruiting NCT04564443 - A Unique Micro Water Jet Technology Device Versus Standard Debridement in the Treatment of Diabetic Foot N/A