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DETEC® pH Point of Care Wound Diagnostic Test

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ClinicalTrials.gov Identifier: NCT04614038
Recruitment Status : Recruiting
First Posted : November 3, 2020
Last Update Posted : July 14, 2021
Sponsor:
Information provided by (Responsible Party):
Progenitec Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Diabetic Foot Ulcer Venous Leg Ulcer Pressure Ulcer Wound, Non-Healed Diagnostic Test: DETEC® pH

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
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Study Type : Observational
Estimated Enrollment : 450 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Estimated Study Start Date : July 2021
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Diagnostic Test: DETEC® pH
    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.

Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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 ]
    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


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants have shown no significant progress toward healing in 30 days and thus been diagnosed with chronic wounds.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04614038


Contacts
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Contact: Wenjing Hu, Ph.D. 682-365-8775 wenjing.hu@progenitec.com

Locations
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United States, Texas
Texas Health Arlington Memorial Wound Care and Limb Preservation Clinic Recruiting
Arlington, Texas, United States, 76012
Contact: Jon Senkowsky, MD       JonSenkowsky@texashealth.org   
Principal Investigator: Jon Senkowsky, MD         
Sponsors and Collaborators
Progenitec Inc.
Investigators
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Principal Investigator: Wenjing Hu, Ph.D. Progenitec Inc.
More Information
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Responsible Party: Progenitec Inc.
ClinicalTrials.gov Identifier: NCT04614038    
Other Study ID Numbers: DETEC 001
First Posted: November 3, 2020    Key Record Dates
Last Update Posted: July 14, 2021
Last Verified: July 2021
Additional relevant MeSH terms:
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Diabetic Foot
Varicose Ulcer
Foot Ulcer
Leg Ulcer
Pressure Ulcer
Ulcer
Wounds and Injuries
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
 Cardiovascular Diseases
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases
Varicose Veins