Intervention for Diabetic Foot Infection

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Diabetic Foot Infection+2 MoreEPC Silver Wound Gel - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Diabetic Foot Ulcers
  • Diabetic Foot Infection
  • Non Healing Diabetic Foot Ulcer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 20 Secondary · Reporting Duration: Within 48-72 hours of first intervention application

Up to 28 days
Incidence of intervention-related adverse events collected throughout the trial
Percent change in wound area and volume during the intervention period compared to baseline.
Progression of systemic biomarker C-Reactive protein (CRP).
Progression of systemic biomarker CBC and Differential.
Progression of systemic biomarker Erythrocyte sedimentation rate (ESR).
Qualitative evaluation of clinician satisfaction via questionnaire.
Qualitative evaluation of patient satisfaction via questionnaire.
Qualitative improvement in quality of life assessment during the intervention period compared with screening period under standard of care.
Up to 42 days
Number of participants with systemic antibiotic or antifungal drug administration over the course of the intervention versus screening and baseline.
Progression in peri-wound microbiome over the course of the intervention versus screening and baseline.
Progression in the absolute number of critical or qualified pathogen species present within the wound microbiome over the course of the intervention versus screening and baseline.
Progression in the relative quantity of critical or qualified pathogens versus commensal organisms present within the wound microbiome over the course of the intervention versus screening and baseline.
Progression in wound microbiome over the course of the intervention versus screening and baseline.
Progression of systemic biomarker body temperature.
Progression of the Infectious Diseases Society of America and International Working Group on the Diabetic Foot Classifications of Diabetic Foot Infection during the intervention period compared with screening period under standard of care.
Progression the Bioburden Assessment Tool (BAT) during the intervention period compared with screening period under standard of care.
Progression the Diabetic Foot Infection (DFI) Wound Score during the intervention period compared with screening period under standard of care.
Quantitative progression of local inflammatory biomarkers over the course of the intervention versus screening and baseline.
Rate of wound closure, specifically percent change in area, during the intervention period compared with screening period under standard of care.
Rate of wound closure, specifically percent change in volume, during the intervention period compared with screening period under standard of care.
Hour 72
Early clinical response

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Intervention
1 of 1

Experimental Treatment

5 Total Participants · 1 Treatment Group

Primary Treatment: Intervention · No Placebo Group · N/A

Intervention
Device
Experimental Group · 1 Intervention: EPC Silver Wound Gel · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: within 48-72 hours of first intervention application

Who is running the clinical trial?

Exciton Technologies Inc.Lead Sponsor
3 Previous Clinical Trials
42 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have diabetes mellitus according to definitions outlined by the American Diabetes Association.
You have a localized mild or local infection of the ulcer as listed in the IWGDF/IDSA Clinical Practice Guideline for the Diagnosis and Treatment of Diabetic Foot Infections (Table 1); exceeding 0.
You have a foot ulcer that is active or persistent, but has not healed in 2 weeks.
Correction or optimization of underlying medical problems (e.g
You must be willing and able to provide written informed consent.
References