An interventional study of NEOX® CORD 1K and Standard of Care (Pressure Bandage) in Foot Ulcer, Diabetic, sponsored by Amniox Medical, Inc.. Terminated at 3 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-06-27.
Sponsored by Amniox Medical, Inc. · Not applicable, Interventional, and Treatment
In this randomized, multi-center, cross-over study, the efficacy and safety of NEOX® CORD 1K will be evaluated in patients suffering from non-healing diabetic foot ulcers. NEOX® CORD 1K is a cryopreserved human Amniotic Membrane and Umbilical Cord (AM/UC) matrix intended for use as a wound covering for dermal ulcers and defects. It is designated as a Human Cell \& Tissue Product (HCT/P) by the U.S. FDA.
Patients identified for the study will have a non-healing diabetic ulcer, between 1-25cm² in size. The patient's wound(s) will be monitored for 2 weeks to document the wound pathology. Patients with less than 30% wound area reduction during the 2 week screening period and who meet all of the inclusion and none of the exclusion criteria, will be enrolled in the study. All patients will be assigned to a study or control group and undergo sharp debridement. NEOX® CORD 1K matrix will be applied to the treatment group on the day of debridement, covered with a wound veil, and standard dressing. Both groups will be monitored weekly, and the % decrease in wound size will be recorded at Baseline and Weeks 1, 2, 3, 4, 6, 8 and 12. If the wound is not progressing, additional application of NEOX® CORD 1K may be applied. The time to complete closure will be recorded for both groups. The study duration will be 12 weeks. Subjects in the control group that continue to suffer a non-healing wound at the week 12 visit will be offered an opportunity to cross-over to NEOX treatment and followed for an additional 12 weeks.
1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's enrollment of 18 is below the median of 60 across 826 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →Amniox Medical, Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Cryopreserved, umbilical cord allograft (NEOX® CORD 1K) with off-loading instructions.
Other: NEOX® CORD 1K
Standard of Care Pressure bandage with off-loading instructions
Procedure: Standard of Care (Pressure Bandage)
Subjects in the Standard of Care (pressure bandage) group that have not healed greater than 50% at the Week 12 visit, or have a wound that is worsening, will be offered participation in the cross-over arm of the trial. The cross-over arm of the study will be treated with NEOX CORD 1K and followed for 12 weeks.
Other: NEOX® CORD 1K · Procedure: Standard of Care (Pressure Bandage)
Amniotic Membrane Tissue is fetal membrane tissue that comprises the innermost layer of the human placenta, and the outermost lining of the umbilical cord. In addition to amniotic membrane, the umbilical cord also contains Wharton's jelly, a rich source of proteoglycans and growth factors. These tissues share the same cell origin as the fetus and serve to protect the fetus during development. This product does not contain live cells.
Also known as: cryopreserved, umbilical cord allograft, cryopreserved human amniotic membrane and umbilical cord, c-hAMUC, AM/UC
Standard of Care wound, pressure dressing applied as needed at each visit.
Complete wound closure
Complete closure of the index wound, defined as 100% re-epithelialization as determined by the Investigator
Time frame: 12 weeks
Number of participants with adverse events
Number of participants with adverse events will be compared between the two groups.
Time frame: 12 weeks
Number of applications
Number of applications of study product (up to 12 weeks from Baseline)
Time frame: 12 weeks
Blinded Reader Assessment
Percent of wounds achieving complete closure per the assessment of a Blinded Reader (by blinded photograph of wound and measurement acetate).
Time frame: 12 weeks and 24 weeks
Time to Initial Wound Closure
Time to initial wound closure (Up to12 weeks from Baseline or 24 weeks for crossover group)
Time frame: Up to 12 weeks or 24 weeks (Crossover)
This study is terminated, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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Amniox Medical, Inc.