The study is evaluating NEOX®CORD 1K, a cryopreserved human umbilical cord allograft. The purpose of the study is to evaluate the safety, incidence and rate of wound closure following application of the product compared to standard of care in the treatment of difficult to heal diabetic foot ulcers.
A total of 114 patients presenting with a non-healing diabetic foot ulcer (DFU) that is located below the malleoli (plantar only) of at least 4 weeks in duration and a size of at least 0.5 cm2 up to 5.0 cm2 for plantar wounds meeting all inclusion criteria but none of the exclusion criteria will be recruited from different trial sites. All patients will receive sharp debridement to remove non-viable tissue followed by standard of care including a sponsor approved standard dressing with a non-adherent wound contact layer, a foam pad or gauze for moderately draining wounds, a secondary bandage, and off-loading device specific to plantar wounds. Eligible patients return at two consecutive visits approximately two weeks apart to assess wound closure. Patients that exhibit a change of less than 30% reduction of the original surface area of their target wound two weeks after the screening visit following debridement will be randomized into the control group or the treatment group at this baseline visit, Week 1. The control group will continue to receive the standard of care and the treatment group will receive standard of care and NEOX® CORD 1KTM. At each weekly visit, all wounds will be adequately debrided of devitalized and necrotic tissue, and the wound dressing will be replaced. For the treatment group, application of NEOX® CORD 1KTM will be considered at each weekly treatment visit following the Investigator's assessment of wound progression. If the Investigator determines it is medically necessary, additional NEOX® CORD 1KTM will be applied, up to and including Week 12 for a maximum of no more than 10 applications. All wounds that close before Week 13 will be followed for an additional two consecutive weekly visits approximately to confirm closure before exiting the trial. Patients who experience closure at the Week 13 visit will be followed for an additional two consecutive visits up to Week 15 to confirm closure. Patients who do not experience wound closure prior to Week 13 will be considered a failure and complete the end of study/Withdrawal Visit 15 exiting the trial. At each weekly visit, efficacy will be assessed by the extent of wound closure as determined by the wound surface area and volume measured by an electronic measurement device (Silhouette®, ARANZ Medical), after debridement if performed, using a standardized protocol. After confirmation of closure, or at Visit 15, all patients will complete the trial. Safety will be assessed by clinical laboratory tests at screening and at End of Study/Withdrawal Visit 15, adverse event (AE) collection, and focused physical exams.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
124
use of human tissue product wound covering
standard wound coverings
Unnamed facility
Carlsbad, California, United States
Unnamed facility
Castro Valley, California, United States
Incidence of adverse events collected throughout the trial compared between the two groups
Time frame: 16 weeks
Proportion of subjects in NEOX® CORD 1KTM plus standard care against standard care with complete wound closure
Time frame: 12 weeks from baseline
Time in days to wound closure
Time frame: 12 weeks from baseline
Proportion of subjects with complete wound closure at each of the 12 treatment
Time frame: 12 weeks from baseline
Percent change in wound area (surface area cm2) at each visit compared to baseline (rate of wound closure)
Time frame: up to 15 weeks from baseline
Percent change in wound volume (cm3) at each visit compared to baseline (rate of wound closure)
Time frame: up to 15 Weeks from baseline
Total Number of applications of the trial product to achieve complete wound closure
Time frame: up to 12 Weeks from Baseline
Difference in score of quality of life assessment determined SF-12v2 at study exit compared to baseline
Time frame: up to 15 weeks from baseline
Difference in score of quality of life assessment determined by Cardiff Wound Impact Schedule (CWIS)
Time frame: up to 15 weeks from baseline
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Fair Oaks, California, United States
Unnamed facility
San Francisco, California, United States
Unnamed facility
Sylmar, California, United States
Unnamed facility
Washington D.C., District of Columbia, United States
Unnamed facility
Miami, Florida, United States
Unnamed facility
North Chicago, Illinois, United States
Unnamed facility
New Orleans, Louisiana, United States
Unnamed facility
Missoula, Montana, United States
...and 12 more locations