A Pilot Study to Assess the Efficacy of NEOX® CORD 1K® in the Treatment of Complex Diabetic Wounds (NCT03296436) | Clinical Trial Compass
WithdrawnEarly Phase 1
A Pilot Study to Assess the Efficacy of NEOX® CORD 1K® in the Treatment of Complex Diabetic Wounds
Stopped: Sponsor decision - sponsor will be initiating a phase 3 mid-2019
0Started 2020-01
Plain-language summary
Patients presenting to Johns Hopkins with a diabetic ulcer classified by the UT Grade 2 or 3 who meet all of the inclusion and none exclusion criteria and give their informed consent, will receive an application of NEOX CORD 1K in addition to standard of care procedures. Those patients will be seen in follow-up at weekly visits until the wound closes and epithelize, achieving complete closure. Subjects that do not achieve complete ulcer closure prior to or at the end of the 16 treatment weeks will exit the study.
Who can participate
Age range18 Years – 100 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Male/female age 18 or older
✓. Type 1 or Type 2 diabetes mellitus
✓. Signed informed consent
✓. Wound present for minimum for four (4) weeks
✓. Wound location foot to include the dorsal or plantar surface
✓. Serum creatinine \< 3.0 mg/dL
✓. HbA1c\< 12% taken prior to randomization
✓. Patient presents with adequate circulation to the effected extremity, as demonstrated
Exclusion criteria
✕3. Unwilling to follow the visit requirements and instructions outlined by the protocol
✕4. Currently receiving radiation therapy or chemotherapy
✕5. Non-vascular surgical site
✕6. The subject's wound can be addressed by primary closure
✕7. Received growth factors, living skin, dermal substitutes, silver-containing products, amniotic membrane or umbilical cord products or other advanced biological therapies for wounds within 30 days of screening