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 range

18 Years – 100 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

complete ulcer closure

Timeframe: 16 weeks

Trial details

NCT IDNCT03296436

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-01

View on ClinicalTrials.gov More Vascular Ulcer (Arterial or Venous Including Diabetic Ulcers Not Located on the Foot) trials