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

Stopped early · Not applicable

Conditions studied: Foot Ulcer, Diabetic

In brief

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 and defects. It is designated as a Human Cell \& Tissue Product (HCT/P) by the U.S. FDA.

Key facts

Study ID

NCT02166294

Run by

Amniox Medical, Inc.

People needed

18

Starts

2014-06-01

Expected to finish

2015-06-01

Last updated by the study team

2017-06-27

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• 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.

You may not qualify if…

• 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%
• 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

Where it is running

• University of Arizona — Tucson, Arizona, United States
• Center for Clinical Research, Inc. — Castro Valley, California, United States
• Ankle and Foot Centers of Georgia — Newnan, Georgia, United States

Full record on ClinicalTrials.gov

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