Non-healing Diabetic Foot Ulcers (DFU) Treated With SoC With or Without NEOX®CORD 1K

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.

Inclusion Criteria:

- 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

- 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

Exclusion Criteria:

- 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,

- 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.