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

NCT05243810 | Completed

• 1 other identifier: PR-0279
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Incidence of intervention-related adverse events collected throughout the trial

  Clinical and/or biological adverse events will be reported over the intervention period. Severity of any adverse events will be graded.

  Up to 28 days

Secondary Outcomes (20)

• Qualitative improvement in quality of life assessment during the intervention period compared with screening period under standard of care.

  Up to 28 days

• 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.

  Up to 42 days

• Progression the Diabetic Foot Infection (DFI) Wound Score during the intervention period compared with screening period under standard of care.

  Up to 42 days

• Progression the Bioburden Assessment Tool (BAT) during the intervention period compared with screening period under standard of care.

  Up to 42 days

• Early clinical response

  Within 48-72 hours of first intervention application

Study Arms (1)

Intervention

EXPERIMENTAL

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.

Device: EPC Silver Wound Gel

Interventions

EPC Silver Wound Gel DEVICE

Re-application of EPC-123 will occur within 48 hours of the initial application. Secondary dressings will be selected at the discretion of the clinician or home care provider, based upon best practice guidelines for moisture management and will consist of a selection between the following secondary dressings: Mesorb® (Molnyke), Gauze, Cling (self-adherent gauze), or MediporeTM (3M). Application of EPC-123 will be executed at the Lawson Health Research Institute every second visit, where interim applications will be facilitated by home care. To support home care applications, a study kit will be provided to home care professionals inclusive of the EPC Silver Wound Gel, secondary dressings required, and instructions for removal/re-application.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Exciton Technologies Inc.: lead

Study Sites (1)

Lawson Health Research Institute

London, Ontario, N6C0A7, Canada

Location

Related Publications (7)

• 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.

  PMID: 32209136 BACKGROUND

• 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/

  PMID: 32105420 BACKGROUND

• 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.

  PMID: 22619242 BACKGROUND

• 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.

  PMID: 19671126 BACKGROUND

• 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.

  PMID: 32176444 BACKGROUND

• 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.

  PMID: 24899053 BACKGROUND

• 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.

  PMID: 10788924 BACKGROUND

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Patients will be assigned an internal ID number
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: February 17, 2022
• Study Start: November 28, 2022
• Primary Completion: September 21, 2023
• Study Completion: September 21, 2023
• Last Updated: September 22, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)