NCT05243810

EPC Silver Wound Gel (EPC-123) Feasibility Study in the Management of Mildly Infected Diabetic Foot Ulcers

EPC Silver Wound Gel (EPC-123) Feasibility Clinical Study: Prospective, Single-arm, Repeated Measures Study of EPC Silver Wound Gel in the Management of Locally Infected Diabetic Foot Ulcers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Exciton Technologies Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this single-arm feasibility study is to investigate the safety and impact of the topical EPC Silver Wound Gel (EPC-123) in the management of diabetic foot ulcer wounds not progressing under the current standard of care.

Detailed description

The objective of the proposed work is 1) to monitor clinical safety of EPC Silver Wound Gel on diabetic foot ulcers, 2) to evaluate the clinical impact of EPC Silver Wound Gel in foot ulcer progression in conjunction with the standard of care 3) to quantify the changes within the wound bacterial environment as it impacts wound healing and 4) to evaluate subjective patient and clinician outcomes: satisfaction, quality of life, perceived benefit, and compliance. Consenting subjects who qualify for enrollment will proceed with two, weekly, visits related to screening. If screen passed, ie. under the current standard of care no progression of the diabetic foot ulcer is observed in accordance with validated diabetic foot ulcer classification metrics, then the subject will proceed with two weeks of study period where twice weekly clinic and twice weekly intermediate home-based care. This may be followed by an additional two weeks of study period, if warranted in accordance with best practice, with once weekly clinic and intermediate home care visits. In total there will be up to 9 clinic visits (minimum 7 clinic visits up to 9 clinic visits) in 6 weeks (screening and trial visits; minimum 4 weeks up to a maximum of 6 weeks).

Conditions

• Diabetic Foot Ulcer
• Non-healing Diabetic Foot Ulcer
• Diabetic Foot Infection

Interventions

Type	Name	Description
DEVICE	EPC Silver Wound Gel	Re-application of EPC-123 will occur within 48 hours of the initial application. Secondary dressings will be selected at the discretion of the clinician or home care provider, based upon best practice guidelines for moisture management and will consist of a selection between the following secondary dressings: Mesorb® (Molnyke), Gauze, Cling (self-adherent gauze), or MediporeTM (3M). Application of EPC-123 will be executed at the Lawson Health Research Institute every second visit, where interim applications will be facilitated by home care. To support home care applications, a study kit will be provided to home care professionals inclusive of the EPC Silver Wound Gel, secondary dressings required, and instructions for removal/re-application.

Timeline

• Start date: 2022-11-28
• Primary completion: 2023-09-21
• Completion: 2023-09-21
• First posted: 2022-02-17
• Last updated: 2023-09-22

Locations

1 site across 1 country: Canada