Recruiting

DETEC®

Sponsor:

Progenitec Inc.

Code:

NCT04614038

Conditions

Diabetic Foot Ulcer

Venous Leg Ulcer

Pressure Ulcer

Wound, Non-Healed

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

DETEC® pH

Study Details

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.

Conditions

Diabetic Foot Ulcer

Venous Leg Ulcer

Pressure Ulcer

Wound, Non-Healed

Study ID

NCT04614038

Start date

Jan 1, 2022

Status verified date

Nov, 2023

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

450 participants

Anticipated

Interventions and Outcome Measures

Interventions

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.

Primary outcome measure

  • Non-healing status based on change in wound area over 12 weeks [ Time Frame: 12 weeks from enrollment ]

Central Contacts and Locations

Central contacts

Wenjing Hu, Ph.D.

682-365-8775wenjing.hu@progenitec.com

Locations

Northwell Health Comprehensive Wound Healing Center

Recruiting

Lake Success, New York, United States, 11042

Contacts

Alisha Oropsllo, MD

Aoropallo@Northwell.edu

More Information

Sponsor

Progenitec Inc.

Last update posted

Nov 18, 2023

Last verified

Nov, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Progenitec Inc. on 2023-11-18.