Clinical trial NCT05243810: EPC Silver Wound Gel (EPC-123) Feasibility Study in the Management of Mildly Infected Diabetic Foot Ulcers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot Ulcer
Non-healing Diabetic Foot Ulcer
Diabetic Foot Infection
Lead sponsor: Exciton Technologies Inc.
Sponsor class: INDUSTRY
First posted: 2022-02-17
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A prospective, single-arm, repeated measures study feasibility study will be coordinated by the Lawson Health Research Institute on the use of EPC Silver Wound Gel (EPC-123) 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, wound ecology, and immunological biomarkers, in conjunction with the standard of care, to clarify parameters for a potential future study.
Primary purpose: TREATMENT

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 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).

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of intervention-related adverse events collected throughout the trial
timeFrame: Up to 28 days
Secondary outcomes:
measure: Qualitative improvement in quality of life assessment during the intervention period compared with screening period under standard of care.
timeFrame: Up to 28 days
measure: 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.
timeFrame: Up to 42 days
measure: Progression the Diabetic Foot Infection (DFI) Wound Score during the intervention period compared with screening period under standard of care.
timeFrame: Up to 42 days
measure: Progression the Bioburden Assessment Tool (BAT) during the intervention period compared with screening period under standard of care.
timeFrame: Up to 42 days
measure: Early clinical response
timeFrame: Within 48-72 hours of first intervention application
measure: Number of participants with systemic antibiotic or antifungal drug administration over the course of the intervention versus screening and baseline.
timeFrame: Up to 42 days
measure: 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.
timeFrame: Up to 42 days
measure: 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.
timeFrame: Up to 42 days
measure: Progression in wound microbiome over the course of the intervention versus screening and baseline.
timeFrame: Up to 42 days
measure: Percent change in wound area and volume during the intervention period compared to baseline.
timeFrame: Up to 28 days
measure: Rate of wound closure, specifically percent change in area, during the intervention period compared with screening period under standard of care.
timeFrame: Up to 42 days
measure: Rate of wound closure, specifically percent change in volume, during the intervention period compared with screening period under standard of care.
timeFrame: Up to 42 days
measure: Qualitative evaluation of patient satisfaction via questionnaire.
timeFrame: Up to 28 days
measure: Qualitative evaluation of clinician satisfaction via questionnaire.
timeFrame: Up to 28 days
measure: Progression of systemic biomarker C-Reactive protein (CRP).
timeFrame: Up to 28 days
measure: Progression of systemic biomarker Erythrocyte sedimentation rate (ESR).
timeFrame: Up to 28 days
measure: Progression of systemic biomarker CBC and Differential.
timeFrame: Up to 28 days
measure: Progression of systemic biomarker body temperature.
timeFrame: Up to 42 days
measure: Progression in peri-wound microbiome over the course of the intervention versus screening and baseline.
timeFrame: Up to 42 days
measure: Quantitative progression of local inflammatory biomarkers over the course of the intervention versus screening and baseline.
timeFrame: Up to 42 days
Other outcomes:
Locations:
city: London
country: Canada
facility: Lawson Health Research Institute
state: Ontario
Study officials:
References:
citation: Armstrong DG, Swerdlow MA, Armstrong AA, Conte MS, Padula WV, Bus SA. Five year mortality and direct costs of care for people with diabetic foot complications are comparable to cancer. J Foot Ankle Res. 2020 Mar 24;13(1):16. doi: 10.1186/s13047-020-00383-2.
citation: Boulton AJM, Armstrong DG, Hardman MJ, Malone M, Embil JM, Attinger CE, Lipsky BA, Aragon-Sanchez J, Li HK, Schultz G, Kirsner RS. Diagnosis and Management of Diabetic Foot Infections. Arlington (VA): American Diabetes Association; 2020 Jan. Available from http://www.ncbi.nlm.nih.gov/books/NBK554227/
citation: Lipsky BA, Berendt AR, Cornia PB, Pile JC, Peters EJ, Armstrong DG, Deery HG, Embil JM, Joseph WS, Karchmer AW, Pinzur MS, Senneville E; Infectious Diseases Society of America. 2012 Infectious Diseases Society of America clinical practice guideline for the diagnosis and treatment of diabetic foot infections. Clin Infect Dis. 2012 Jun;54(12):e132-73. doi: 10.1093/cid/cis346.
citation: Lipsky BA, Polis AB, Lantz KC, Norquist JM, Abramson MA. The value of a wound score for diabetic foot infections in predicting treatment outcome: a prospective analysis from the SIDESTEP trial. Wound Repair Regen. 2009 Sep-Oct;17(5):671-7. doi: 10.1111/j.1524-475X.2009.00521.x. Epub 2009 Aug 11.
citation: Lipsky BA, Senneville E, Abbas ZG, Aragon-Sanchez J, Diggle M, Embil JM, Kono S, Lavery LA, Malone M, van Asten SA, Urbancic-Rovan V, Peters EJG; International Working Group on the Diabetic Foot (IWGDF). Guidelines on the diagnosis and treatment of foot infection in persons with diabetes (IWGDF 2019 update). Diabetes Metab Res Rev. 2020 Mar;36 Suppl 1:e3280. doi: 10.1002/dmrr.3280.
citation: Blome C, Baade K, Debus ES, Price P, Augustin M. The "Wound-QoL": a short questionnaire measuring quality of life in patients with chronic wounds based on three established disease-specific instruments. Wound Repair Regen. 2014 Jul-Aug;22(4):504-14. doi: 10.1111/wrr.12193.
citation: Houghton PE, Kincaid CB, Campbell KE, Woodbury MG, Keast DH. Photographic assessment of the appearance of chronic pressure and leg ulcers. Ostomy Wound Manage. 2000 Apr;46(4):20-6, 28-30.