Diabetic Foot UlcerNCT04614038
DETEC® pH Point of Care Wound Diagnostic Test
An observational study of Diabetic Foot Ulcer and Venous Leg Ulcer, run by Progenitec Inc. at 2 sites in United States.
Trial summary
The purpose of this study is to determine the relationship between wound alkalinity and the non-healing status of chronic ulcer wounds. It is hypothesized that wounds with an alkaline environment as indicated by DETEC pH will have a high chance of not healing over 12 weeks of 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® pH
- How many people
- 450 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jan 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 have shown no significant progress toward healing in 30 days and thus been diagnosed 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
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
- Scheduled for or likely to have significant surgical intervention to the studied wound (e.g. skin graft or flap, amputation) during the study period.
- With a life expectancy of fewer than 6 months
- 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
2 sites in 1 country.
United States2 sites, 2 recruiting
- Enrolling by invitation
Complex Healthcare Solutions
Arlington, Texas, 76018
- Recruiting
Northwell Health Comprehensive Wound Healing Center
Lake Success, New York, 11042
Alisha Oropsllo, MD, Aoropallo@Northwell.edu
About this study
Official title: Non-interventional, Prospective, Single-blinded, Observational, Multicenter, Cohort, Clinical Study to Evaluate DETEC® pH Device as a Prognostic Tool in the Identification of Non-healing Chronic Wounds
The purpose of this study is to determine the relationship between wound alkalinity and the non-healing status of chronic ulcer wounds. It is hypothesized that wounds with an alkaline environment as indicated by DETEC pH will have a high chance of not healing over 12 weeks of wound care.
Read the detailed description
Chronic wounds fail to progress through normal wound healing phases in a timely manner which makes them non-healing over time. The inability to identify a slowly healing or non-healing wound early on can be detrimental to the patient's well-being. Currently, determination of non-healing wounds is based on the clinician's visual observation of wound size changes for 4 weeks. Many early studies have documented that chronic, non-healing, or infected wounds often reside in an alkaline state (pH > 7.2) while healing wounds are habitually associated with a non-alkaline and even acidic environment.
To reliably and continuously monitor wound alkalinity objectively, a portable, disposable, non-invasive, and non-contact device - DETEC® pH - was developed to indirectly assess the alkalinity of wounds by analyzing the wound exudate adsorbed on to freshly discarded wound dressings during the participants' routine follow-up visit. A follow-up visit and 7-21 days after the initial wound diagnosis and care, subjects will be screened and enrolled in this investigation based on the inclusion and exclusion criteria. Their wound dressings will be tested using the device. The device outputs and wound conditions will be recorded. The subjects' wounds will be managed using standard care by the provider at each visit. The device output will not be used to inform the treatment decision in this study.
At 12 weeks after initial wound diagnosis, the subjects will be required to present themselves for a follow-up/end of study wound healing status assessment.
The device outputs will then be compared to the clinical healing status of the wounds (healed or not healed) at week 12. For the study, a healed wound is defined as one that has achieved complete wound closure that is defined as skin re-epithelialization without drainage or dressing requirements (100% of the wound is covered and the surface is intact), as assessed by the treating clinician.
- Being tested
- DETEC® pH
- Medical subject headings
- Diabetic Foot, Varicose Ulcer, Pressure Ulcer, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DETEC® pHDiagnostic test
DETEC® pH is a disposable diagnostic device that is used to indicate the alkalinity of the wound by testing wound exudate adsorbed onto wound dressing.
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-healing status based on change in wound area over 12 weeks
The primary endpoint is non-healing wounds (that do not have 100 percent wound closure) at the end of 12 weeks
Measured: 12 weeks from enrollment
Secondary outcomes (1)
Effect of various patient biometry and wound conditions on non-healing status based on change in wound area over 12 weeks
The secondary effectiveness endpoint is healing or non-healing wounds over 12 weeks based on subject's age, race, initial wound size, wound location, wound type, clinical sites and presence or absence of infection
Measured: 12 weeks from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start1 Jan 2022
- Primary completion31 Dec 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
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Progenitec Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wenjing Hu, Ph.D., Principal investigator, Progenitec Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04614038
- Sponsor's protocol ID
- DETEC 001
- Status last verified
- Nov 2023
- First submitted
- 22 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® pH Device as a Prognostic Tool in the Identification of Non-healing Chronic Wounds
- ClinicalTrials.gov ID
- NCT04614038
- Acronym / sponsor ID
- DETEC 001
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Progenitec Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 3 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.
The purpose of this study is to determine the relationship between wound alkalinity and the non-healing status of chronic ulcer wounds. It is hypothesized that wounds with an alkaline environment as indicated by DETEC pH will have a high chance of not healing over 12 weeks of wound care.
Detailed description
Chronic wounds fail to progress through normal wound healing phases in a timely manner which makes them non-healing over time. The inability to identify a slowly healing or non-healing wound early on can be detrimental to the patient's well-being. Currently, determination of non-healing wounds is based on the clinician's visual observation of wound size changes for 4 weeks. Many early studies have documented that chronic, non-healing, or infected wounds often reside in an alkaline state (pH > 7.2) while healing wounds are habitually associated with a non-alkaline and even acidic environment.
To reliably and continuously monitor wound alkalinity objectively, a portable, disposable, non-invasive, and non-contact device - DETEC® pH - was developed to indirectly assess the alkalinity of wounds by analyzing the wound exudate adsorbed on to freshly discarded wound dressings during the participants' routine follow-up visit. A follow-up visit and 7-21 days after the initial wound diagnosis and care, subjects will be screened and enrolled in this investigation based on the inclusion and exclusion criteria. Their wound dressings will be tested using the device. The device outputs and wound conditions will be recorded. The subjects' wounds will be managed using standard care by the provider at each visit. The device output will not be used to inform the treatment decision in this study.
At 12 weeks after initial wound diagnosis, the subjects will be required to present themselves for a follow-up/end of study wound healing status assessment.
The device outputs will then be compared to the clinical healing status of the wounds (healed or not healed) at week 12. For the study, a healed wound is defined as one that has achieved complete wound closure that is defined as skin re-epithelialization without drainage or dressing requirements (100% of the wound is covered and the surface is intact), as assessed by the treating clinician.
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 have shown no significant progress toward healing in 30 days and thus been diagnosed with chronic wounds.
Key inclusion criteria (4 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
Key exclusion criteria (8 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
- Scheduled for or likely to have significant surgical intervention to the studied wound (e.g. skin graft or flap, amputation) during the study period.
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® pHDETEC® pH is a disposable diagnostic device that is used to indicate the alkalinity of the wound by testing wound exudate adsorbed onto wound dressing. | Diagnostic test | – |
Primary outcome
Non-healing status based on change in wound area over 12 weeks
Time frame: 12 weeks from enrollment
The primary endpoint is non-healing wounds (that do not have 100 percent wound closure) at the end of 12 weeks
1 secondary outcome
Effect of various patient biometry and wound conditions on non-healing status based on change in wound area over 12 weeks
Time frame: 12 weeks 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, Ph.D. principal investigator
Progenitec Inc.
2 sites 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 2 sites 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 4 inclusion and 8 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 2 sites 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, Ph.D. (682-365-8775, wenjing.hu@progenitec.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-healing status based on change in wound area over 12 weeks (time frame: 12 weeks 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.