Diabetic Foot UlcersNCT02707406
Non-healing Diabetic Foot Ulcers (DFU) Treated With SoC With or Without NEOX®CORD 1K
A study testing NEOX®CORD 1K in people with Diabetic Foot Ulcers, run by BioTissue Holdings, Inc at 22 sites in 2 countries.
Trial summary
The study is evaluating NEOX®CORD 1K, a cryopreserved human umbilical cord allograft. The purpose of the study is to evaluate the safety, incidence and rate of wound closure following application of the product compared to standard of care in the treatment of difficult to heal diabetic foot ulcers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcers
- What is being tested?
- NEOX®CORD 1K
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 22 sitesin 2 countries
- Study dates
- Feb 2016to 9 Oct 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has signed the informed consent form
- Male or female patient at least 18 years of age or older, as of the date of the screening visit
- Confirmed diagnosis of Type I or Type II Diabetes
- Has an index ulcer that is located below the malleoli on the plantar surface of at least 0.5 cm2 or up to 5.0 cm2 when measured by the investigator staff at the screening visit using the ARANZ Silhouette post debridement.
- The depth of the index foot ulcer is graded as Wagner Grade I or II, i.e., with no evidence of exposed muscle, tendon, bone, or joint capsule
- The index ulcer is "chronic, non-healing," defined as having a duration of > 4 weeks but not > 52 weeks at the screening visit
Show all 14Show fewer
- Arterial supply adequacy to the foot with the index ulcer confirmed by any one of the following:
- Great toe pressure ≥ 40 mm/Hg
- Systolic blood pressure Ankle Brachial Index (ABI) in the range ≥ 0.65 ≤ 1.20
- TcPO2 ≥ 30 mmHg from the foot •
- Normal triphasic or biphasic waveform pattern at the ankle
- Toe Brachial Index or TBI ≥ 0.50
- Willing to follow all instructions including off-loading given by the Investigator
- Willing to return for all mandatory visits as defined in the protocol
Who cannot join
- Renal impairment marked by serum creatinine \& serum total BUN > 2 times the upper limit of normal or is currently receiving renal dialysis
- Hemoglobin A1c (HbA1c) level is > 12% (108 mmol/mol)
- Has an abnormally low serum albumin, as evidenced by an albumin level ≥ 2.0 g/dl,
- A white blood cell count < 2.0 x109 /L, neutrophils < 1.0 x109 /L, platelets < 100 x109 /L
- Chronic oral steroid use of > 7.5 mg daily for greater than 7 consecutive days within the previous 30 days preceding screening
- Chronic oral or parenteral corticosteroids, or any cytotoxic agents for 7 consecutive days within the previous 30 days preceding screening,
Show all 24Show fewer
- Has tested positive for Human Immunodeficiency Virus (HIV) or has Acquired Immune Deficiency Syndrome (AIDS)
- Has malignancy or history of cancer in 5 years preceding the screening visit other than non-melanoma skin cancer
- Pregnant women
- Women of child-bearing potential who are unwilling to avoid pregnancy or use an effective form of birth control
- Is currently enrolled or participated in another device, drug, or biological trial within 30 days of screening
- Has had within the last 7 days, is currently undergoing, or is planning for wound treatments with enzymes, growth factors, living skin, dermal substitutes including other amniotic or umbilical cord tissue therapies, or other advanced biological therapies
- Current use of topical anti-microbial or silver-containing products
- Has an allergy to primary or secondary dressing materials used in this trial
- Has an allergy to amphotericin-B or Dulbecco's Modified Eagle Medium (DMEM)
- Index ulcer is over an active Charcot deformity
- The depth of the index ulcer is graded as Wagner Grade III or higher, i.e., with evidence of exposed muscle, tendon, bone, and/or joint capsule (see Appendix 2)
- Gangrene is present on any part of the affected foot
- Current suspicion of osteomyelitis, cellulitis, or other clinical signs or symptoms of index ulcer infection
- Any previous use of NEOX® CORD 1KTM in the index ulcer
- The following exclusion criteria is to be reviewed for all subjects prior to randomization:
- Has an index ulcer that has decreased in ulcer area > 30% post debridement at baseline post the Run-in period.
- Use of excluded concomitant medications, therapies, or procedures during the Run-in period.
- Clinical signs or symptoms of infection of the index ulcer.
Trial locations and contacts
22 sites in 2 countries.
22 sites in 2 countries
United States19 sites
Study site
Carlsbad, California
Study site
Castro Valley, California
Study site
Eugene, Oregon
Study site
Fair Oaks, California
Study site
Fort Worth, Texas
Study site
Las Vegas, Nevada
Study site
McAllen, Texas
Study site
Miami, Florida
Study site
Missoula, Montana
Study site
Murray, Utah
Study site
New Orleans, Louisiana
Study site
North Chicago, Illinois
Study site
Portland, Oregon
Study site
Roanoke, Virginia
Study site
San Antonio, Texas
Study site
San Francisco, California
Study site
Sylmar, California
Study site
Virginia Beach, Virginia
Study site
Washington D.C., District of Columbia
Canada3 sites
Study site
Boucherville, Quebec
Study site
Hamilton, Ontario
Study site
London, Ontario
About this study
Official title: A Multi-center, Randomized, Controlled Study of Non-healing Diabetic Foot Ulcers (DFU) Treated With Standard of Care With or Without Cryopreserved Umbilical Cord Allograft (NEOX®CORD 1K)
The study is evaluating NEOX®CORD 1K, a cryopreserved human umbilical cord allograft.
The purpose of the study is to evaluate the safety, incidence and rate of wound closure following application of the product compared to standard of care in the treatment of difficult to heal diabetic foot ulcers.
Read the detailed description
A total of 114 patients presenting with a non-healing diabetic foot ulcer (DFU) that is located below the malleoli (plantar only) of at least 4 weeks in duration and a size of at least 0.5 cm2 up to 5.0 cm2 for plantar wounds meeting all inclusion criteria but none of the exclusion criteria will be recruited from different trial sites. All patients will receive sharp debridement to remove non-viable tissue followed by standard of care including a sponsor approved standard dressing with a non-adherent wound contact layer, a foam pad or gauze for moderately draining wounds, a secondary bandage, and off-loading device specific to plantar wounds. Eligible patients return at two consecutive visits approximately two weeks apart to assess wound closure. Patients that exhibit a change of less than 30% reduction of the original surface area of their target wound two weeks after the screening visit following debridement will be randomized into the control group or the treatment group at this baseline visit, Week 1. The control group will continue to receive the standard of care and the treatment group will receive standard of care and NEOX® CORD 1KTM. At each weekly visit, all wounds will be adequately debrided of devitalized and necrotic tissue, and the wound dressing will be replaced. For the treatment group, application of NEOX® CORD
1KTM will be considered at each weekly treatment visit following the Investigator's assessment of wound progression. If the Investigator determines it is medically necessary, additional NEOX® CORD 1KTM will be applied, up to and including Week 12 for a maximum of no more than 10 applications. All wounds that close before Week 13 will be followed for an additional two consecutive weekly visits approximately to confirm closure before exiting the trial. Patients who experience closure at the Week 13 visit will be followed for an additional two consecutive visits up to Week 15 to confirm closure. Patients who do not experience wound closure prior to Week 13 will be considered a failure and complete the end of study/Withdrawal Visit 15 exiting the trial.
At each weekly visit, efficacy will be assessed by the extent of wound closure as determined by the wound surface area and volume measured by an electronic measurement device (Silhouette®, ARANZ Medical), after debridement if performed, using a standardized protocol. After confirmation of closure, or at Visit 15, all patients will complete the trial.
Safety will be assessed by clinical laboratory tests at screening and at End of Study/Withdrawal Visit 15, adverse event (AE) collection, and focused physical exams.
- Conditions
- Diabetic Foot Ulcers
- Being tested
- NEOX®CORD 1K, standard of care
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEOX®CORD 1KOther
use of human tissue product wound covering
standard of careOther
standard wound coverings
| Study group | Role | What they receive |
|---|---|---|
| NEOX®CORD 1K | Experimental | Intervention Other: hct/p human cell or tissue product: NEOX®CORD 1K Intervention other: human tissue application of of NEOX®CORD 1K on subject wound Receives: Other: NEOX®CORD 1K; Other: standard of care |
| Standard of Care | Active comparator | Intervention Other: standard of care alone Other intervention of Standard dressing with a non-adherent wound contact layer, a classic foam pad or gauze for moderately draining wounds, a secondary bandage, and institution of an investigator-approved off-loading device Receives: Other: standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events collected throughout the trial compared between the two groups
Measured: 16 weeks
Secondary outcomes (8)
Proportion of subjects in NEOX® CORD 1KTM plus standard care against standard care with complete wound closure
Measured: 12 weeks from baseline
Time in days to wound closure
Measured: 12 weeks from baseline
Proportion of subjects with complete wound closure at each of the 12 treatment
Measured: 12 weeks from baseline
Percent change in wound area (surface area cm2) at each visit compared to baseline (rate of wound closure)
Measured: up to 15 weeks from baseline
Percent change in wound volume (cm3) at each visit compared to baseline (rate of wound closure)
Measured: up to 15 Weeks from baseline
Total Number of applications of the trial product to achieve complete wound closure
Measured: up to 12 Weeks from Baseline
Difference in score of quality of life assessment determined SF-12v2 at study exit compared to baseline
Measured: up to 15 weeks from baseline
Difference in score of quality of life assessment determined by Cardiff Wound Impact Schedule (CWIS)
Measured: up to 15 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completion14 Apr 2017
- Study completion9 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcersStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioTissue Holdings, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02707406
- Sponsor's protocol ID
- NE-2011
- Status last verified
- Jun 2019
- First submitted
- 25 Feb 2016
- Last updated
- 28 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Controlled Study of Non-healing Diabetic Foot Ulcers (DFU) Treated With Standard of Care With or Without Cryopreserved Umbilical Cord Allograft (NEOX®CORD 1K)
- ClinicalTrials.gov ID
- NCT02707406
- Acronym / sponsor ID
- NE-2011
- Conditions
- Diabetic Foot Ulcers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- BioTissue Holdings, IncIndustry (pharma, biotech, devices)
- Study start
- Feb 2016 (actual)
- Primary completion
- 14 Apr 2017 (actual)
- Study completion
- 9 Oct 2018 (actual)
- First posted
- 14 Mar 2016 (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.
The study is evaluating NEOX®CORD 1K, a cryopreserved human umbilical cord allograft.
The purpose of the study is to evaluate the safety, incidence and rate of wound closure following application of the product compared to standard of care in the treatment of difficult to heal diabetic foot ulcers.
Detailed description
A total of 114 patients presenting with a non-healing diabetic foot ulcer (DFU) that is located below the malleoli (plantar only) of at least 4 weeks in duration and a size of at least 0.5 cm2 up to 5.0 cm2 for plantar wounds meeting all inclusion criteria but none of the exclusion criteria will be recruited from different trial sites. All patients will receive sharp debridement to remove non-viable tissue followed by standard of care including a sponsor approved standard dressing with a non-adherent wound contact layer, a foam pad or gauze for moderately draining wounds, a secondary bandage, and off-loading device specific to plantar wounds. Eligible patients return at two consecutive visits approximately two weeks apart to assess wound closure. Patients that exhibit a change of less than 30% reduction of the original surface area of their target wound two weeks after the screening visit following debridement will be randomized into the control group or the treatment group at this baseline visit, Week 1. The control group will continue to receive the standard of care and the treatment group will receive standard of care and NEOX® CORD 1KTM. At each weekly visit, all wounds will be adequately debrided of devitalized and necrotic tissue, and the wound dressing will be replaced. For the treatment group, application of NEOX® CORD
1KTM will be considered at each weekly treatment visit following the Investigator's assessment of wound progression. If the Investigator determines it is medically necessary, additional NEOX® CORD 1KTM will be applied, up to and including Week 12 for a maximum of no more than 10 applications. All wounds that close before Week 13 will be followed for an additional two consecutive weekly visits approximately to confirm closure before exiting the trial. Patients who experience closure at the Week 13 visit will be followed for an additional two consecutive visits up to Week 15 to confirm closure. Patients who do not experience wound closure prior to Week 13 will be considered a failure and complete the end of study/Withdrawal Visit 15 exiting the trial.
At each weekly visit, efficacy will be assessed by the extent of wound closure as determined by the wound surface area and volume measured by an electronic measurement device (Silhouette®, ARANZ Medical), after debridement if performed, using a standardized protocol. After confirmation of closure, or at Visit 15, all patients will complete the trial.
Safety will be assessed by clinical laboratory tests at screening and at End of Study/Withdrawal Visit 15, adverse event (AE) collection, and focused physical exams.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NEOX®CORD 1K | Experimental | Other: NEOX®CORD 1K, Other: standard of careIntervention Other: hct/p human cell or tissue product: NEOX®CORD 1K Intervention other: human tissue application of of NEOX®CORD 1K on subject wound |
| Standard of Care | Active comparator | Other: standard of careIntervention Other: standard of care alone Other intervention of Standard dressing with a non-adherent wound contact layer, a classic foam pad or gauze for moderately draining wounds, a secondary bandage, and institution of an investigator-approved off-loading device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patient has signed the informed consent form
- Male or female patient at least 18 years of age or older, as of the date of the screening visit
- Confirmed diagnosis of Type I or Type II Diabetes
- Has an index ulcer that is located below the malleoli on the plantar surface of at least 0.5 cm2 or up to 5.0 cm2 when measured by the investigator staff at the screening visit using the ARANZ Silhouette post debridement.
- The depth of the index foot ulcer is graded as Wagner Grade I or II, i.e., with no evidence of exposed muscle, tendon, bone, or joint capsule
Key exclusion criteria (24 listed)
- Renal impairment marked by serum creatinine \& serum total BUN > 2 times the upper limit of normal or is currently receiving renal dialysis
- Hemoglobin A1c (HbA1c) level is > 12% (108 mmol/mol)
- Has an abnormally low serum albumin, as evidenced by an albumin level ≥ 2.0 g/dl,
- A white blood cell count < 2.0 x109 /L, neutrophils < 1.0 x109 /L, platelets < 100 x109 /L
- Chronic oral steroid use of > 7.5 mg daily for greater than 7 consecutive days within the previous 30 days preceding screening
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 1Kuse of human tissue product wound covering | Other | NEOX®CORD 1K |
| standard of carestandard wound coverings | Other | NEOX®CORD 1K, Standard of Care |
Primary outcome
Incidence of adverse events collected throughout the trial compared between the two groups
Time frame: 16 weeks
8 secondary outcomes
Proportion of subjects in NEOX® CORD 1KTM plus standard care against standard care with complete wound closure
Time frame: 12 weeks from baseline
Time in days to wound closure
Time frame: 12 weeks from baseline
Proportion of subjects with complete wound closure at each of the 12 treatment
Time frame: 12 weeks from baseline
Percent change in wound area (surface area cm2) at each visit compared to baseline (rate of wound closure)
Time frame: up to 15 weeks from baseline
Percent change in wound volume (cm3) at each visit compared to baseline (rate of wound closure)
Time frame: up to 15 Weeks from baseline
Total Number of applications of the trial product to achieve complete wound closure
Time frame: up to 12 Weeks from Baseline
Difference in score of quality of life assessment determined SF-12v2 at study exit compared to baseline
Time frame: up to 15 weeks from baseline
Difference in score of quality of life assessment determined by Cardiff Wound Impact Schedule (CWIS)
Time frame: up to 15 weeks from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Diabetic Foot Ulcers
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.
The record lists no contact. Use the official record to reach the sponsor.
22 sites in 2 countries: 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 Diabetic Foot Ulcers, run by BioTissue Holdings, Inc at 22 sites in 2 countries.
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 14 inclusion and 24 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: finished, as of the sponsor's last update on 28 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Canada. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of adverse events collected throughout the trial compared between the two groups (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jun 2019.