Diabetic Foot UlcerNCT05243810
EPC Silver Wound Gel (EPC-123) Feasibility Study in the Management of Mildly Infected Diabetic Foot Ulcers
A study testing EPC Silver Wound Gel in people with Diabetic Foot Ulcer and Non-healing Diabetic Foot Ulcer, run by Exciton Technologies Inc. at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer, Non-healing Diabetic Foot Ulcer, Diabetic Foot Infection
- What is being tested?
- EPC Silver Wound Gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteCanada
- Study dates
- 28 Nov 2022to 21 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 9Show fewer
- IDSA-defined severe infection, including systemic toxicity or metabolic instability
- Current use of enzymatic debridement.
- Participants with known silver sensitivity
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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).
- Being tested
- EPC Silver Wound Gel
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPC Silver Wound GelDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: EPC Silver Wound Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Quality of life will be assessed using the qualitative "Wound QoL" tool during the intervention period compared with qualitative assessment at baseline.
Measured: 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.
Progressions of PEDIS (grade 1 = no symptoms or signs of infection; to grade 4, local infection with the signs of systemic inflammatory response syndrome) or IDSA Infection Severity (Uninfected; to Severe) during the intervention period compared with screening period under standard of care.
Measured: Up to 42 days
Progression the Diabetic Foot Infection (DFI) Wound Score during the intervention period compared with screening period under standard of care.
Signs and symptoms of infection will be assessed using the 10-item DFI Wound Score system inclusive of semi-quantitative measurement of purulent discharge, non-purulent discharge, erythema, induration, tenderness, pain, warmth, size, depth, undermining. The DFI Wound Score ranges from a score of 3 (less severe wound) to 49 (more severe wound). Rate of change in DFI score during the intervention period will be compared with screening period under standard of care.
Measured: Up to 42 days
Progression the Bioburden Assessment Tool (BAT) during the intervention period compared with screening period under standard of care.
The degree of bioburden will be assessed using BAT; measuring for the presence or absence of signs and symptoms of infection and bioburden and subsequent clinical interpretation. Progressions of the level of bioburden risk, from Category I (colonized: at risk) to Category VI (systemic infection), during the intervention period will be compared with screening period under standard of care.
Measured: Up to 42 days
Early clinical response
Quantitation of lesion erythema area and wound area at 48-72 hours following the first intervention application.
Measured: Within 48-72 hours of first intervention application
Number of participants with systemic antibiotic or antifungal drug administration over the course of the intervention versus screening and baseline.
Report on the number of participants receiving administration of systemic antibiotic or antifungal drugs during the intervention period compared with screening period under standard of care.
Measured: Up to 42 days
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 absolute number of critical or qualified pathogens (inclusive of those pathogens identified by the Centre for Disease Control and Prevention, World Health Organization, and the FDA as per 79 FR 32464) as per gene pyrosequencing over the course of intervention versus screening and baseline.
Measured: Up to 42 days
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 the relative composition of critical or qualified pathogens (inclusive of those pathogens identified by the Centre for Disease Control and Prevention, World Health Organization, and the FDA as per 79 FR 32464) versus commensal organisms in the wound microbiome of as per gene pyrosequencing over the course of intervention versus screening and baseline.
Measured: Up to 42 days
Progression in wound microbiome over the course of the intervention versus screening and baseline.
Progression of the wound microbiome on a whole ecology basis as per gene pyrosequencing; evaluating for community membership, structure, and diversity over the course of intervention versus screening and baseline.
Measured: Up to 42 days
Percent change in wound area and volume during the intervention period compared to baseline.
Percent change in wound volume (cm3) at each visit compared to baseline.
Measured: Up to 28 days
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, change in wound area (cm2), over the course of the intervention period compared to the screening period.
Measured: Up to 42 days
Rate of wound closure, specifically percent change in volume, during the intervention period compared with screening period under standard of care.
Rate of wound closure, change in wound volume (cm3), over the course of the intervention period compared to the screening period.
Measured: Up to 42 days
Qualitative evaluation of patient satisfaction via questionnaire.
Patient satisfaction over the course of the intervention period will evaluated. Patient satisfaction of the performance of the intervention will be evaluated within a rating scale of "poor" through to "excellent".
Measured: Up to 28 days
Qualitative evaluation of clinician satisfaction via questionnaire.
Clinician satisfaction over the course of the intervention period will evaluated. Clinician satisfaction of the performance of the intervention will be evaluated within a rating scale of "poor" through to "excellent".
Measured: Up to 28 days
Progression of systemic biomarker C-Reactive protein (CRP).
Quantitation of clinical change in CRP (mg/L) from baseline to end of intervention period.
Measured: Up to 28 days
Progression of systemic biomarker Erythrocyte sedimentation rate (ESR).
Quantitation of clinical change in ESR (mm/hr) from baseline to end of intervention period.
Measured: Up to 28 days
Progression of systemic biomarker CBC and Differential.
Quantitation of clinical change in CBC and Differential (cells per cubic millimeter) from baseline to end of intervention period.
Measured: Up to 28 days
Progression of systemic biomarker body temperature.
Quantitation of clinical change in body temperature (degree Celsius) over the course of the intervention versus screening and baseline.
Measured: Up to 42 days
Progression in peri-wound microbiome over the course of the intervention versus screening and baseline.
Progression of the peri-wound microbiome on a whole ecology basis as per gene pyrosequencing; evaluating for community membership, structure, and diversity over the course of intervention versus screening and baseline.
Measured: Up to 42 days
Quantitative progression of local inflammatory biomarkers over the course of the intervention versus screening and baseline.
Quantitation of host inflammatory cytokines and chemokines (pg/ml) inclusive of: IL-1, IL-6, IL-8, IL-10 TNF-α, MMP-8, MMP-9, MMP-2, TIMP1, and TIMP2; within the wound over the course of the intervention versus screening and baseline.
Measured: Up to 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start28 Nov 2022
- Primary completion21 Sep 2023
- Study completion21 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Exciton Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05243810
- Sponsor's protocol ID
- PR-0279
- Status last verified
- Jan 2023
- First submitted
- 11 Jan 2022
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32209136Boulton 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/
PubMed 32105420Lipsky 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.
PubMed 22619242Lipsky 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.
PubMed 19671126Lipsky 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.
PubMed 32176444Blome 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.
PubMed 24899053Houghton 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.
PubMed 10788924
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05243810
- Acronym / sponsor ID
- PR-0279
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Exciton Technologies Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Nov 2022 (actual)
- Primary completion
- 21 Sep 2023 (actual)
- Study completion
- 21 Sep 2023 (actual)
- First posted
- 17 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: EPC Silver Wound GelA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EPC Silver Wound GelRe-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. | Device | Intervention |
Primary outcome
Incidence of intervention-related adverse events collected throughout the trial
Time frame: Up to 28 days
Clinical and/or biological adverse events will be reported over the intervention period. Severity of any adverse events will be graded.
20 secondary outcomes
Qualitative improvement in quality of life assessment during the intervention period compared with screening period under standard of care.
Time frame: 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.
Time frame: Up to 42 days
Progression the Diabetic Foot Infection (DFI) Wound Score during the intervention period compared with screening period under standard of care.
Time frame: Up to 42 days
Progression the Bioburden Assessment Tool (BAT) during the intervention period compared with screening period under standard of care.
Time frame: Up to 42 days
Early clinical response
Time frame: Within 48-72 hours of first intervention application
Number of participants with systemic antibiotic or antifungal drug administration over the course of the intervention versus screening and baseline.
Time frame: Up to 42 days
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.
Time frame: Up to 42 days
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.
Time frame: Up to 42 days
Progression in wound microbiome over the course of the intervention versus screening and baseline.
Time frame: Up to 42 days
Percent change in wound area and volume during the intervention period compared to baseline.
Time frame: Up to 28 days
Rate of wound closure, specifically percent change in area, during the intervention period compared with screening period under standard of care.
Time frame: Up to 42 days
Rate of wound closure, specifically percent change in volume, during the intervention period compared with screening period under standard of care.
Time frame: Up to 42 days
Qualitative evaluation of patient satisfaction via questionnaire.
Time frame: Up to 28 days
Qualitative evaluation of clinician satisfaction via questionnaire.
Time frame: Up to 28 days
Progression of systemic biomarker C-Reactive protein (CRP).
Time frame: Up to 28 days
Progression of systemic biomarker Erythrocyte sedimentation rate (ESR).
Time frame: Up to 28 days
Progression of systemic biomarker CBC and Differential.
Time frame: Up to 28 days
Progression of systemic biomarker body temperature.
Time frame: Up to 42 days
Progression in peri-wound microbiome over the course of the intervention versus screening and baseline.
Time frame: Up to 42 days
Quantitative progression of local inflammatory biomarkers over the course of the intervention versus screening and baseline.
Time frame: Up to 42 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Background: PubMed 32209136Armstrong 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.
- Background: PubMed 32105420Boulton 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/
- Background: PubMed 22619242Lipsky 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.
- Background: PubMed 19671126Lipsky 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.
- Background: PubMed 32176444Lipsky 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.
- Background: PubMed 24899053Blome 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.
- Background: PubMed 10788924Houghton 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EPC Silver Wound Gel in people with Diabetic Foot Ulcer and Non-healing Diabetic Foot Ulcer, run by Exciton Technologies Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of intervention-related adverse events collected throughout the trial (time frame: Up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05243810, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2023.