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

Exciton Technologies

Status: Completed

Conditions: Diabetic Foot Infection; Diabetic Foot Ulcer; Non-healing Diabetic Foot Ulcer

Treatments: Device: EPC Silver Wound Gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT05243810

PR-0279

Details and patient eligibility

About

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.

Full 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).

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Intervention

Experimental group

Description:

A prospective, single-arm, repeated measures feasibility study will be coordinated on the use of EPC Silver Wound Gel in patients with diabetic foot ulcers and localized infections within an outpatient clinical setting, to determine the safety of EPC Silver Wound Gel on diabetic foot ulcerations and impact on wound infection classification, wound ecology, and immunological biomarkers, in conjunction with the standard of care, to clarify parameters for a potential future study.

Treatment:

Device: EPC Silver Wound Gel