Foot Ulcer, DiabeticCONDUCT INCT02166294

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

A study testing NEOX® CORD 1K in people with Foot Ulcer, Diabetic, run by Amniox Medical, Inc. at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

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… Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Foot Ulcer, Diabetic
What is being tested?: NEOX® CORD 1K
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 3 sitesUnited States
Study dates: Jun 2014to Jun 2015
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Between 18 years and 80 years of age inclusive
Confirmed diagnosis of Type I or Type II Diabetes
Males and Females diagnosed with a diabetic foot ulcer that is 1-25cm²
At least one foot ulcer that is UT Grade IA
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
The Index Ulcer is located below the malleoli on the plantar or dorsal surface of the foot

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The Index Ulcer extends into the dermis or subcutaneous tissue with no evidence of exposed muscle, tendon, bone, or joint capsule
Wound is free of necrotic debris and clinical signs of infection
Patient has adequate circulation to the foot
In patients with non-compressible ankle vessels there is adequate flow to the foot.

Who cannot join

The Index Ulcer is of non-diabetic pathophysiology and/or over an active Charcot deformity
The Index Ulcer is UT Grade IB or higher (worsening)
Gangrene is present on any part of the affected foot
The longest dimension of the Index Ulcer exceeds 5 cm at the Baseline Visit
Patient is currently receiving renal dialysis
Patient has a glycated hemoglobin A1c (HbA1c) level of > 12%

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Patient has significant renal impairment
Chronic oral steroid use > 7.5 mg daily
Requiring intravenous (IV) antibiotics to treat the index wound infection
Patient has an ulcer within 15cm of the Index Ulcer identified for study consideration
Patient is receiving oral or parenteral corticosteroids, immunosuppressive or cytotoxic agents
Patient is Human Immunodeficiency Virus (HIV) positive or has Acquired Immune Deficiency Syndrome (AIDS)
Current evidence of osteomyelitis, cellulitis, or other evidence of infection including fever or purulent drainage from the wound site
Patient has active malignancy other than non-melanoma skin cancer
Patient's Index Ulcer has decreased by ≥ 30% during 2-week screening period
Patient has untreated alcohol or substance abuse at the time of screening
Pregnant women
Patient is currently enrolled or participated in another investigational device, drug, or biologic trial within 60 days of screening
Patient has allergy to primary or secondary dressing materials used in this trial
Patient has an allergy to amphotericin-B or Dulbecco's Modified Eagle Medium (DMEM)
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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

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

Other trials in United States

About this study

Official title: 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

Read the 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.

Conditions: Foot Ulcer, Diabetic
Being tested: NEOX® CORD 1K, Standard of Care (Pressure Bandage)
Keywords: Foot, Ulcer, Diabetes, Amputation, Limb salvage
Medical subject headings: Diabetic Foot, Ulcer, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NEOX® CORD 1KOther
Also called cryopreserved, umbilical cord allograft, cryopreserved human amniotic membrane and umbilical cord, c-hAMUC, AM/UC
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.
Standard of Care (Pressure Bandage)Procedure or surgery
Standard of Care wound, pressure dressing applied as needed at each visit.

Study groups in NCT02166294
Study group	Role	What they receive
NEOX® CORD 1K	Experimental	Cryopreserved, umbilical cord allograft (NEOX® CORD 1K) with off-loading instructions. Receives: Other: NEOX® CORD 1K
Pressure bandage	Active comparator	Standard of Care Pressure bandage with off-loading instructions Receives: Procedure: Standard of Care (Pressure Bandage)
Standard of Care Cross over to NEOX	Experimental	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. Receives: Other: NEOX® CORD 1K; Procedure: Standard of Care (Pressure Bandage)

What is being measured

The primary outcome is the main question the study is designed to answer.

Complete wound closure
Complete closure of the index wound, defined as 100% re-epithelialization as determined by the Investigator
Measured: 12 weeks
Number of participants with adverse events
Number of participants with adverse events will be compared between the two groups.
Measured: 12 weeks

Secondary outcomes (3)

Number of applications
Number of applications of study product (up to 12 weeks from Baseline)
Measured: 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).
Measured: 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)
Measured: Up to 12 weeks or 24 weeks (Crossover)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2014Jun 2015

First posted18 Jun 2014 (estimated)
Study startJun 2014
Primary completionJun 2015
Study completionJun 2015

Why it stopped: Sponsor decision

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Foot Ulcer, DiabeticStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02166294
Sponsor's protocol ID: NE-2001
Acronym: CONDUCT I
Status last verified: Jun 2017
First submitted: 16 Jun 2014
Last updated: 27 Jun 2017
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
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Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
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Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
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Better Care Closer to Home: Enhancing Primary and Community Care
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All Foot Ulcer, Diabetic trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT02166294
Acronym / sponsor ID: CONDUCT I / NE-2001
Conditions: Foot Ulcer, Diabetic
Keywords: Foot, Ulcer, Diabetes, Amputation, Limb salvage
Study type: Interventional
Recruitment status: TerminatedReason stopped: Sponsor decision
Enrolment: 18 participants (actual)
Lead sponsor: Amniox Medical, Inc.Industry (pharma, biotech, devices)
Study start: Jun 2014
Primary completion: Jun 2015 (actual)
Study completion: Jun 2015 (actual)
First posted: 18 Jun 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
NEOX® CORD 1K	Experimental	Other: NEOX® CORD 1KCryopreserved, umbilical cord allograft (NEOX® CORD 1K) with off-loading instructions.
Pressure bandage	Active comparator	Procedure: Standard of Care (Pressure Bandage)Standard of Care Pressure bandage with off-loading instructions
Standard of Care Cross over to NEOX	Experimental	Other: NEOX® CORD 1K, 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.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Between 18 years and 80 years of age inclusive
Confirmed diagnosis of Type I or Type II Diabetes
Males and Females diagnosed with a diabetic foot ulcer that is 1-25cm²
At least one foot ulcer that is UT Grade IA
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

Key exclusion criteria (21 listed)

The Index Ulcer is of non-diabetic pathophysiology and/or over an active Charcot deformity
The Index Ulcer is UT Grade IB or higher (worsening)
Gangrene is present on any part of the affected foot
The longest dimension of the Index Ulcer exceeds 5 cm at the Baseline Visit
Patient is currently receiving renal dialysis

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NEOX® CORD 1KAlso: cryopreserved, umbilical cord allograft, cryopreserved human amniotic membrane and umbilical cord, c-hAMUC, AM/UCAmniotic 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	NEOX® CORD 1K, Standard of Care Cross over to NEOX
Standard of Care (Pressure Bandage)Standard of Care wound, pressure dressing applied as needed at each visit.	Procedure or surgery	Pressure bandage, Standard of Care Cross over to NEOX

Primary outcome

Complete wound closure
Time frame: 12 weeks
Complete closure of the index wound, defined as 100% re-epithelialization as determined by the Investigator
Number of participants with adverse events
Time frame: 12 weeks
Number of participants with adverse events will be compared between the two groups.

3 secondary outcomes

Number of applications
Time frame: 12 weeks
Blinded Reader Assessment
Time frame: 12 weeks and 24 weeks
Time to Initial Wound Closure
Time frame: Up to 12 weeks or 24 weeks (Crossover)

Results and safety

The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2017.

Related trials for Foot Ulcer, Diabetic

Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Charles I. Romano study director

Amniox Medical, Inc.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing NEOX® CORD 1K in people with Foot Ulcer, Diabetic, run by Amniox Medical, Inc. at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete wound closure (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02166294.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2017.