Diabetic Foot UlcerNCT04614870
DETEC® Esterase for Screening Wound Infection at Point of Care
An observational study of Diabetic Foot Ulcer and Venous Leg Ulcer, run by Progenitec Inc. at 1 site in United States.
Trial summary
This non-interventional, single-blinded, prospective, observational study assesses the planar distribution of leukocyte esterase in wounds by placing wound exudates soaked wound dressings in the DETEC® Esterase device during routine wound care. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Diabetic Foot Ulcer, Venous Leg Ulcer, Pressure Ulcer
- What is being tested?
- DETEC® Esterase
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2022to 31 Dec 2024
- Phase
- Observational
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with chronic wounds
Who may be able to join
- Adult (21 years), male or female, inpatient/outpatient, presenting with a wound
- Chronic wound open for at least 30 days, including (Diabetic foot ulcers (DFU), Wagner grade 1 to 3), (Pressure ulcers, stage 2 to 4), (Venous leg ulcers (VLU), confirmed by venous duplex/Doppler),
- For wounds on a lower extremity (i.e. DFU, VLU) an ankle-brachial index (ABI) of greater than 0.6 for the affected leg to ensure ischemia will not impact healing
- For diabetic foot ulcers - confirmed type 1 or type 2 diabetes mellitus with a hemoglobin A1C less than 10 percentage
- Wound shows clinical signs of infection - pain, erythema, edema, heat, surrounding erythema, swelling, or purulent exudate
Who cannot join
- History of autoimmune disease/ acquired immunodeficiency syndrome/Hepatitis
- Require treatment for primary or metastatic malignancy
- Any contra-indication to routine wound care and/or monitoring
- Women who are pregnant, lactating, or of childbearing potential and currently not taking adequate birth control
- Participation (less than 30 days prior to baseline) in an interventional trial which could have a potential effect on the study outcome, as determined by the Investigator
- Patients with a dry dressing
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Complex Healthcare Solutions
Arlington, Texas, 76018
Jon Senkowsky, MD, JonSenkowsky@complexhs.com
Jon Senkowsky, MD
About this study
Official title: Non-interventional, Prospective, Single-blinded, Observational, Multicenter, Cohort, Clinical Study to Evaluate DETEC® Esterase for the Detection of Infections in Chronic Wounds
This non-interventional, single-blinded, prospective, observational study assesses the planar distribution of leukocyte esterase in wounds by placing wound exudates soaked wound dressings in the DETEC® Esterase device during routine wound care. The output of the device is correlated with clinical determination of infection to assess the device efficacy in identifying presumptive infections.
Read the detailed description
There is no commercial available device to diagnosze infection in chronic wounds. Since qualitative measures of leukocyte esterase (LE) have been used clinically as a biomarker to screen for various infectious diseases including urinary tract infections, peritonitis and joint infections, it is likely that LE can also be used a a biomarker to screen infection in chronic wounds. To test this hypothesis, an investigational device - DETEC® Esterase - has been developed to detect elevated LE in wound exudates absorbed wound dressings. With increasing LE levels, this coloration becomes more intense (from colorless/pink to dark purple) indicating infection.
The overall goals of the study are as follows:
- To assess the efficacy of DETEC® Esterase in detecting ulcer wound infection by comparing device output with the wound care specialist's final determination of infection
- To evaluate the effect of the subject's age, race, wound size, location, type, and clinical site on the device's ability to identify non-healing wounds.
- To study the sensitivity, specificity, and accuracy of DETEC® Esterase in assessing infection by testing discarded wound dressings with varying levels of esterase activities.
Patients presenting themselves to the clinic with ulcer wounds will be assessed by the clinicians. Those with at least one clinical sign and symptom of a wound infection will be enrolled and recorded in the study. The participant's first visit can be concurrent with enrollment. During this visit, the participants' wound dressings will be tested using DETEC® Esterase device by a project nurse/tester not involved with subjects' wound management and the output recorded. Wounds will be managed by the clinicians who are blinded from the device output. Consequently, the clinician may adjudicate the presence or absence of infection based on all available information to make a clinical diagnosis of infection. The device determination of presumptive infection will then be compared with the results of the doctor's adjudication.
- Conditions
- Diabetic Foot Ulcer, Venous Leg Ulcer, Pressure Ulcer
- Being tested
- DETEC® Esterase
- Medical subject headings
- Diabetic Foot, Varicose Ulcer, Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DETEC® EsteraseDiagnostic test
DETEC® Esterase is a disposable diagnostic device that is used to indicate the presence or absence of infection based on the presence or absence of the evaluated level of leukocyte esterase by testing the freshly recovered wound dressing which are soaked with wound exudate.
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive predictive value of the device in the determination of infection in wounds with clinical signs of infection
The primary endpoint is agreement in infected wound determination between device output and providers' adjudication in wounds with suspected infection.
Measured: 15 days from enrollment
Secondary outcomes (2)
Positive predictive value of the device in the determination of infection in wounds with various patient and wound conditions
The secondary endpoint is identifying infection in wounds with various biometry and disease conditions (age, gender, race, wound size, wound locations, wound types, infection status, and clinical sites).
Measured: 15 days from enrollment
Likelihood of infection
Another secondary endpoint is the likelihood of infection with positive and negative test results
Measured: 15 days from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start1 May 2022
- Primary completion31 May 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Progenitec Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wenjing Hu, PhD, Principal investigator, Progenitec Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04614870
- Sponsor's protocol ID
- DETEC 002
- Status last verified
- Nov 2023
- First submitted
- 28 Oct 2020
- Last updated
- 18 Nov 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional, Prospective, Single-blinded, Observational, Multicenter, Cohort, Clinical Study to Evaluate DETEC® Esterase for the Detection of Infections in Chronic Wounds
- ClinicalTrials.gov ID
- NCT04614870
- Acronym / sponsor ID
- DETEC 002
- Conditions
- Diabetic Foot Ulcer, Venous Leg Ulcer, Pressure Ulcer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Progenitec Inc.Industry (pharma, biotech, devices)
- Study start
- 1 May 2022 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 4 Nov 2020 (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.
This non-interventional, single-blinded, prospective, observational study assesses the planar distribution of leukocyte esterase in wounds by placing wound exudates soaked wound dressings in the DETEC® Esterase device during routine wound care. The output of the device is correlated with clinical determination of infection to assess the device efficacy in identifying presumptive infections.
Detailed description
There is no commercial available device to diagnosze infection in chronic wounds. Since qualitative measures of leukocyte esterase (LE) have been used clinically as a biomarker to screen for various infectious diseases including urinary tract infections, peritonitis and joint infections, it is likely that LE can also be used a a biomarker to screen infection in chronic wounds. To test this hypothesis, an investigational device - DETEC® Esterase - has been developed to detect elevated LE in wound exudates absorbed wound dressings. With increasing LE levels, this coloration becomes more intense (from colorless/pink to dark purple) indicating infection.
The overall goals of the study are as follows:
- To assess the efficacy of DETEC® Esterase in detecting ulcer wound infection by comparing device output with the wound care specialist's final determination of infection
- To evaluate the effect of the subject's age, race, wound size, location, type, and clinical site on the device's ability to identify non-healing wounds.
- To study the sensitivity, specificity, and accuracy of DETEC® Esterase in assessing infection by testing discarded wound dressings with varying levels of esterase activities.
Patients presenting themselves to the clinic with ulcer wounds will be assessed by the clinicians. Those with at least one clinical sign and symptom of a wound infection will be enrolled and recorded in the study. The participant's first visit can be concurrent with enrollment. During this visit, the participants' wound dressings will be tested using DETEC® Esterase device by a project nurse/tester not involved with subjects' wound management and the output recorded. Wounds will be managed by the clinicians who are blinded from the device output. Consequently, the clinician may adjudicate the presence or absence of infection based on all available information to make a clinical diagnosis of infection. The device determination of presumptive infection will then be compared with the results of the doctor's adjudication.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with chronic wounds
Key inclusion criteria (5 listed)
- Adult (21 years), male or female, inpatient/outpatient, presenting with a wound
- Chronic wound open for at least 30 days, including (Diabetic foot ulcers (DFU), Wagner grade 1 to 3), (Pressure ulcers, stage 2 to 4), (Venous leg ulcers (VLU), confirmed by venous duplex/Doppler),
- For wounds on a lower extremity (i.e. DFU, VLU) an ankle-brachial index (ABI) of greater than 0.6 for the affected leg to ensure ischemia will not impact healing
- For diabetic foot ulcers - confirmed type 1 or type 2 diabetes mellitus with a hemoglobin A1C less than 10 percentage
- Wound shows clinical signs of infection - pain, erythema, edema, heat, surrounding erythema, swelling, or purulent exudate
Key exclusion criteria (6 listed)
- History of autoimmune disease/ acquired immunodeficiency syndrome/Hepatitis
- Require treatment for primary or metastatic malignancy
- Any contra-indication to routine wound care and/or monitoring
- Women who are pregnant, lactating, or of childbearing potential and currently not taking adequate birth control
- Participation (less than 30 days prior to baseline) in an interventional trial which could have a potential effect on the study outcome, as determined by the Investigator
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 |
|---|---|---|
| DETEC® EsteraseDETEC® Esterase is a disposable diagnostic device that is used to indicate the presence or absence of infection based on the presence or absence of the evaluated level of leukocyte esterase by testing the freshly recovered wound dressing which are soaked with wound exudate. | Diagnostic test | – |
Primary outcome
Positive predictive value of the device in the determination of infection in wounds with clinical signs of infection
Time frame: 15 days from enrollment
The primary endpoint is agreement in infected wound determination between device output and providers' adjudication in wounds with suspected infection.
2 secondary outcomes
Positive predictive value of the device in the determination of infection in wounds with various patient and wound conditions
Time frame: 15 days from enrollment
Likelihood of infection
Time frame: 15 days from enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
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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.
Wenjing Hu, PhD principal investigator
Progenitec Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Foot Ulcer and Venous Leg Ulcer, run by Progenitec Inc. at 1 site in United States.
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 6 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: status not confirmed, as of the sponsor's last update on 18 Nov 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wenjing Hu, PhD (6823658775, wenjing.hu@progenitec.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive predictive value of the device in the determination of infection in wounds with clinical signs of infection (time frame: 15 days from enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Nov 2023.