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

This is an interventional treatment trial for Diabetic Foot Ulcers Read More

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.