Vascular Ulcer (Arterial or Venous Including Diabetic Ulcers Not Located on the Foot)Early Phase 1NCT03296436
A Pilot Study to Assess the Efficacy of NEOX® CORD 1K® in the Treatment of Complex Diabetic Wounds
A Early Phase 1 study testing NEOX® CORD 1K® in people with Vascular Ulcer (Arterial or Venous Including Diabetic Ulcers Not Located on the Foot) and Diabetic Foot Ulcer, run by Johns Hopkins University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Vascular Ulcer (Arterial or Venous Including Diabetic Ulcers Not Located on the Foot), Diabetic Foot Ulcer, Diabetic Foot
- What is being tested?
- NEOX® CORD 1K®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2020to Oct 2021
- Phase
- Early Phase 1
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- HbA1c< 12% taken prior to randomization
- Patient presents with adequate circulation to the effected extremity, as demonstrated
- by one of the following within sixty (60) days:
- Ankle-Brachial Index (ABI) with results of >0.6 and <1.2
- Doppler arterial waveforms which are triphasic or biphasic at ankle of affected lower extremity
- Wound is diabetic in origin with and area of > 1 cm2 and < 16 cm2 at time of screening
Who cannot join
- Unwilling to follow the visit requirements and instructions outlined by the protocol
- Currently receiving radiation therapy or chemotherapy
- Non-vascular surgical site
- The subject's wound can be addressed by primary closure
- 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
- Pregnant or breast feeding
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- HbA1c: > 12% within previous ninety (90) days
- Serum creatinine level > 3.0 mg/dL Taking medications that are considered immune system modulators
- Uncontrolled autoimmune surgical sites
- Known or suspected local skin malignancy
About this study
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.
Read the detailed description
A prospective investigator initiated trial will be conducted in diabetic patients with lower extremity wounds managed with NEOX CORD 1K umbilical cord product supplied by Amniox (a subsidiary of TissueTech, Inc.). The patient population will be comprised of Type 1 or Type 2 diabetics presenting to our hospital for the treatment of lower extremity wounds occurring on the dorsal and plantar foot. The wounds will be treated in the Operating Room (OR) arena including surgical debridement, resection of bone necrosis, biopsy, etc. to treat the associated morbidity. These wounds are classified utilizing the University of Texas (UT) Classification System as Grades: 2 (wounds penetrating to tendon or capsule) and 3 (wounds penetrating to bone or joint) with Stages: A (no infection or ischemia), B (Infection present), C (ischemia present) and D (Infection and ischemia present). This morbidity will comprise of complex wounds that exhibit exposed muscle, tendon, bone and may include the presence of treated osteomyelitis. This patient population oftentimes include diabetics with lower extremity ischemia or end stage renal disease and their associated comorbidities. These wounds are challenging in their care being they trend towards a poor prognosis including high morbidity and mortality as well as high major limb amputation rates. Hence, this trial will provide associated data to the efficacy of the above referenced material towards evaluating its effectiveness in these wound types towards enhancing wound healing and subsequently reducing amputation rates.
- Conditions
- Vascular Ulcer (Arterial or Venous Including Diabetic Ulcers Not Located on the Foot), Diabetic Foot Ulcer, Diabetic Foot, Diabetic Foot Infection, Diabetic Foot Ulcer Mixed
- Being tested
- NEOX® CORD 1K®
- 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 1K®Biological
NEOX CORD 1K is a cryopreserved human umbilical cord product derived from donated human placental tissue following healthy, live, caesarian section, full-term births after determination of donor eligibility and placenta suitability. NEOX CORD 1K is manufactured by TissueTech Inc. utilizing a proprietary CRYOTEK® process, which devitalizes the living cells but retains the natural structural and biological characteristics relevant to this tissue. NEOX CORD 1K is aseptically processed in compliance with current Good Tissue Practices (cGTP). NEOX CORD 1K of various sizes is stored in a medium of Dulbecco's Modified Eagle Medium/Glycerol (1:1) containing Amphotericin B (an anti-fungal agent). NEOX CORD 1K will be applied to completely cover the wound area and is maintained stationary with sutures or even negative pressure wound therapy after adequate sharp debridement.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Group that will be receiving the investigational product Receives: Biological: NEOX® CORD 1K® |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete ulcer closure
Proportion of subjects with confirmed complete ulcer closure at sixteen (16) weeks, confirmed by being closed for 30 days.
Measured: 16 weeks
Secondary outcomes (5)
NEOX CORD 1K applications
Total number of NEOX CORD 1K applications the subject received over the treatment period
Measured: 16 weeks
ulcer surface area
Percent change in the ulcer surface area (cm2) at each visit from baseline
Measured: 16 weeks
number of days to complete wound closure
Time in number of days to complete wound closure over the 16-week treatment period
Measured: 16 weeks
Mean cost to closure
Mean cost to closure
Measured: 16 weeks
recurrent ulcer-related complications
- Proportion of subjects who experience recurrent ulcer-related complications (e.g., sepsis, osteomyelitis, limb amputation)
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2017
- Study startJan 2020 (estimated)
- Primary completionJan 2021 (estimated)
- Study completionOct 2021 (estimated)
Why it stopped: Sponsor decision - sponsor will be initiating a phase 3 mid-2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular Ulcer (Arterial or Venous Including Diabetic Ulcers Not Located on the Foot)Studies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rondald Sherman, DPM, MBA, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03296436
- Sponsor's protocol ID
- IRB00145403
- Status last verified
- Feb 2019
- First submitted
- 25 Sep 2017
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess the Efficacy of NEOX® CORD 1K® in the Treatment of Complex Diabetic Wounds
- ClinicalTrials.gov ID
- NCT03296436
- Acronym / sponsor ID
- IRB00145403
- Conditions
- Vascular Ulcer (Arterial or Venous Including Diabetic Ulcers Not Located on the Foot), Diabetic Foot Ulcer, Diabetic Foot, Diabetic Foot Infection, Diabetic Foot Ulcer Mixed
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor decision - sponsor will be initiating a phase 3 mid-2019
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Jan 2020 (estimated)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 28 Sep 2017 (actual)
- 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.
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.
Detailed description
A prospective investigator initiated trial will be conducted in diabetic patients with lower extremity wounds managed with NEOX CORD 1K umbilical cord product supplied by Amniox (a subsidiary of TissueTech, Inc.). The patient population will be comprised of Type 1 or Type 2 diabetics presenting to our hospital for the treatment of lower extremity wounds occurring on the dorsal and plantar foot. The wounds will be treated in the Operating Room (OR) arena including surgical debridement, resection of bone necrosis, biopsy, etc. to treat the associated morbidity. These wounds are classified utilizing the University of Texas (UT) Classification System as Grades: 2 (wounds penetrating to tendon or capsule) and 3 (wounds penetrating to bone or joint) with Stages: A (no infection or ischemia), B (Infection present), C (ischemia present) and D (Infection and ischemia present). This morbidity will comprise of complex wounds that exhibit exposed muscle, tendon, bone and may include the presence of treated osteomyelitis. This patient population oftentimes include diabetics with lower extremity ischemia or end stage renal disease and their associated comorbidities. These wounds are challenging in their care being they trend towards a poor prognosis including high morbidity and mortality as well as high major limb amputation rates. Hence, this trial will provide associated data to the efficacy of the above referenced material towards evaluating its effectiveness in these wound types towards enhancing wound healing and subsequently reducing amputation rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Biological: NEOX® CORD 1K®Group that will be receiving the investigational product |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (10 listed)
- Unwilling to follow the visit requirements and instructions outlined by the protocol
- Currently receiving radiation therapy or chemotherapy
- Non-vascular surgical site
- The subject's wound can be addressed by primary closure
- 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
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 1K®NEOX CORD 1K is a cryopreserved human umbilical cord product derived from donated human placental tissue following healthy, live, caesarian section, full-term births after determination of donor eligibility and placenta suitability. NEOX CORD 1K is manufactured by TissueTech Inc. utilizing a proprietary CRYOTEK® process, which devitalizes the living cells but retains the natural structural and biological characteristics relevant to this tissue. NEOX CORD 1K is aseptically processed in compliance with current Good Tissue Practices (cGTP). NEOX CORD 1K of various sizes is stored in a medium of Dulbecco's Modified Eagle Medium/Glycerol (1:1) containing Amphotericin B (an anti-fungal agent). NEOX CORD 1K will be applied to completely cover the wound area and is maintained stationary with sutures or even negative pressure wound therapy after adequate sharp debridement. | Biological | Treatment Group |
Primary outcome
complete ulcer closure
Time frame: 16 weeks
Proportion of subjects with confirmed complete ulcer closure at sixteen (16) weeks, confirmed by being closed for 30 days.
5 secondary outcomes
NEOX CORD 1K applications
Time frame: 16 weeks
ulcer surface area
Time frame: 16 weeks
number of days to complete wound closure
Time frame: 16 weeks
Mean cost to closure
Time frame: 16 weeks
recurrent ulcer-related complications
Time frame: 16 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
- Individual participant dataSharing planned: Undecided
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.
Rondald Sherman, DPM, MBA principal investigator
Johns Hopkins University
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing NEOX® CORD 1K® in people with Vascular Ulcer (Arterial or Venous Including Diabetic Ulcers Not Located on the Foot) and Diabetic Foot Ulcer, run by Johns Hopkins University.
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 12 inclusion and 10 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: withdrawn, as of the sponsor's last update on 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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 ulcer closure (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 27 Feb 2019.