NEOX® CORD 1K vs Standard of Care in Non-healing Diabetic Foot Ulcers (CONDUCT I)

June 26, 2017 updated by: Amniox Medical, Inc.

A Multi-center, Randomized, Parallel, Crossover Design Study of Non-healing Diabetic Foot Ulcers, Treated With Cryopreserved, Umbilical Cord Allograft (NEOX® CORD 1K) Versus Standard of Care That Are Followed for 12 Weeks

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
        • University of Arizona
    • California
      • Castro Valley, California, United States, 94115
        • Center for Clinical Research, Inc.
    • Georgia
      • Newnan, Georgia, United States, 30265
        • Ankle and Foot Centers of Georgia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Between 18 years and 80 years of age inclusive
  2. Confirmed diagnosis of Type I or Type II Diabetes
  3. Males and Females diagnosed with a diabetic foot ulcer that is 1-25cm²
  4. At least one foot ulcer that is UT Grade IA
  5. Evidence of proper circulation which includes: An Index Ulcer defined as chronic (presence of wound for > 4 weeks) but not present for more than 52 weeks at the Screening Visit
  6. The Index Ulcer is located below the malleoli on the plantar or dorsal surface of the foot
  7. The Index Ulcer extends into the dermis or subcutaneous tissue with no evidence of exposed muscle, tendon, bone, or joint capsule
  8. Wound is free of necrotic debris and clinical signs of infection
  9. Patient has adequate circulation to the foot
  10. In patients with non-compressible ankle vessels there is adequate flow to the foot.

Exclusion Criteria:

  1. The Index Ulcer is of non-diabetic pathophysiology and/or over an active Charcot deformity
  2. The Index Ulcer is UT Grade IB or higher (worsening)
  3. Gangrene is present on any part of the affected foot
  4. The longest dimension of the Index Ulcer exceeds 5 cm at the Baseline Visit
  5. Patient is currently receiving renal dialysis
  6. Patient has a glycated hemoglobin A1c (HbA1c) level of > 12%
  7. Patient has significant renal impairment
  8. Chronic oral steroid use > 7.5 mg daily
  9. Requiring intravenous (IV) antibiotics to treat the index wound infection
  10. Patient has an ulcer within 15cm of the Index Ulcer identified for study consideration
  11. Patient is receiving oral or parenteral corticosteroids, immunosuppressive or cytotoxic agents
  12. Patient is Human Immunodeficiency Virus (HIV) positive or has Acquired Immune Deficiency Syndrome (AIDS)
  13. Current evidence of osteomyelitis, cellulitis, or other evidence of infection including fever or purulent drainage from the wound site
  14. Patient has active malignancy other than non-melanoma skin cancer
  15. Patient's Index Ulcer has decreased by ≥ 30% during 2-week screening period
  16. Patient has untreated alcohol or substance abuse at the time of screening
  17. Pregnant women
  18. Patient is currently enrolled or participated in another investigational device, drug, or biologic trial within 60 days of screening
  19. Patient has allergy to primary or secondary dressing materials used in this trial
  20. Patient has an allergy to amphotericin-B or Dulbecco's Modified Eagle Medium (DMEM)
  21. Patient has had within the last 30 days, or is currently undergoing, or is planning for wound treatments with enzymes, growth factors, living skin, dermal substitutes or other advanced biological therapies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: NEOX® CORD 1K
Cryopreserved, umbilical cord allograft (NEOX® CORD 1K) with off-loading instructions.
Other: NEOX® CORD 1K
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.
Other Names:
  • cryopreserved, umbilical cord allograft
  • cryopreserved human amniotic membrane and umbilical cord
  • c-hAMUC
  • AM/UC
Active Comparator: Pressure bandage
Standard of Care Pressure bandage with off-loading instructions
Procedure: Standard of Care (Pressure Bandage)
Standard of Care wound, pressure dressing applied as needed at each visit.
Experimental: Standard of Care Cross over to NEOX
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
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.
Other Names:
  • cryopreserved, umbilical cord allograft
  • cryopreserved human amniotic membrane and umbilical cord
  • c-hAMUC
  • AM/UC
Procedure: Standard of Care (Pressure Bandage)
Standard of Care wound, pressure dressing applied as needed at each visit.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Complete wound closure
Time Frame: 12 weeks
Complete closure of the index wound, defined as 100% re-epithelialization as determined by the Investigator
12 weeks
Number of participants with adverse events
Time Frame: 12 weeks
Number of participants with adverse events will be compared between the two groups.
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of applications
Time Frame: 12 weeks
Number of applications of study product (up to 12 weeks from Baseline)
12 weeks
Blinded Reader Assessment
Time Frame: 12 weeks and 24 weeks
Percent of wounds achieving complete closure per the assessment of a Blinded Reader (by blinded photograph of wound and measurement acetate).
12 weeks and 24 weeks
Time to Initial Wound Closure
Time Frame: Up to 12 weeks or 24 weeks (Crossover)
Time to initial wound closure (Up to12 weeks from Baseline or 24 weeks for crossover group)
Up to 12 weeks or 24 weeks (Crossover)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Amniox Medical, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Charles I. Romano, Amniox Medical, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 16, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 18, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 27, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NE-2001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Foot Ulcer, Diabetic

Clinical Trials on NEOX® CORD 1K

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings