Status:
COMPLETED
EPC Silver Wound Gel (EPC-123) Feasibility Study in the Management of Mildly Infected Diabetic Foot Ulcers
Lead Sponsor:
Exciton Technologies Inc.
Conditions:
Diabetic Foot Ulcer
Non-healing Diabetic Foot Ulcer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
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 progressio...
Eligibility Criteria
Inclusion
- Diagnosed with diabetes mellitus according to definitions outlined by the American Diabetes Association
- Presenting with an active or current foot ulcer that has been identified as stalled or persistent non-healing under current standard-of-care; showing no progression in 2 weeks as per IDSA guidelines.
- Presenting with 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 0.5 cm2 in area after appropriate debridement.
- Subject must agree to adhere to all protocol procedures and must be willing and able to provide written informed consent.
- Correction or optimization of underlying medical problems (e.g. diabetes or systemic infection).
Exclusion
- Participants exhibiting extensive gangrene, and/or immediately limb-threatening infection
- Indications of osteomyelitis identified by plain radiographs taken within 2 days prior to study entry.
- No palpable dorsalis pedis or posterior tibial pulse or a pedal systolic pressure (Doppler ultrasound) of ≤ 40 mm Hg
- Clinically significant peripheral arterial disease requiring vascular intervention
- Patients requiring renal dialysis, immunosuppressive mediation, or those with uncontrolled hypertension.
- Lymphangitis; spread beneath the fascia; muscle, joint, or bone involvement.
- IDSA-defined severe infection, including systemic toxicity or metabolic instability
- Current use of enzymatic debridement.
- Participants with known silver sensitivity
Key Trial Info
Start Date :
November 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 21 2023
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT05243810
Start Date
November 28 2022
End Date
September 21 2023
Last Update
September 22 2023
Active Locations (1)
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1
Lawson Health Research Institute
London, Ontario, Canada, N6C0A7