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

Diabetic Foot Ulcer Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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). ;

Related Conditions & MeSH terms

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

• NCT number: NCT05243810
• Study type: Interventional
• Source: Exciton Technologies Inc.
• Status: Completed
• Phase: N/A
• Start date: November 28, 2022
• Completion date: September 21, 2023