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

NCT02166294 | Terminated

• 1 other identifier: NE-2001
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Foot Ulcer, Diabetic

Keywords

Foot; Ulcer; Diabetes; Amputation; Limb salvage

Outcome Measures

Primary Outcomes (2)

• Complete wound closure

  Complete closure of the index wound, defined as 100% re-epithelialization as determined by the Investigator

  12 weeks

• Number of participants with adverse events

  Number of participants with adverse events will be compared between the two groups.

  12 weeks

Secondary Outcomes (3)

• Number of applications

  12 weeks

• Blinded Reader Assessment

  12 weeks and 24 weeks

• Time to Initial Wound Closure

  Up to 12 weeks or 24 weeks (Crossover)

Study Arms (3)

NEOX® CORD 1K

EXPERIMENTAL

Cryopreserved, umbilical cord allograft (NEOX® CORD 1K) with off-loading instructions.

Other: NEOX® CORD 1K

Pressure bandage

ACTIVE COMPARATOR

Standard of Care Pressure bandage with off-loading instructions

Procedure: Standard of Care (Pressure Bandage)

Standard of Care Cross over to NEOX

EXPERIMENTAL

Subjects in the Standard of Care (pressure bandage) group that have not healed greater than 50% at the Week 12 visit, or have a wound that is worsening, will be offered participation in the cross-over arm of the trial. The cross-over arm of the study will be treated with NEOX CORD 1K and followed for 12 weeks.

Other: NEOX® CORD 1K; Procedure: Standard of Care (Pressure Bandage)

Interventions

NEOX® CORD 1K OTHER

Amniotic Membrane Tissue is fetal membrane tissue that comprises the innermost layer of the human placenta, and the outermost lining of the umbilical cord. In addition to amniotic membrane, the umbilical cord also contains Wharton's jelly, a rich source of proteoglycans and growth factors. These tissues share the same cell origin as the fetus and serve to protect the fetus during development. This product does not contain live cells.

Also known as: cryopreserved, umbilical cord allograft, cryopreserved human amniotic membrane and umbilical cord, c-hAMUC, AM/UC

NEOX® CORD 1K; Standard of Care Cross over to NEOX

Standard of Care (Pressure Bandage) PROCEDURE

Standard of Care wound, pressure dressing applied as needed at each visit.

Pressure bandage; Standard of Care Cross over to NEOX

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Amniox Medical, Inc.: lead

Study Sites (3)

University of Arizona

Tucson, Arizona, 85724, United States

Location

Center for Clinical Research, Inc.

Castro Valley, California, 94115, United States

Location

Ankle and Foot Centers of Georgia

Newnan, Georgia, 30265, United States

Location

MeSH Terms

Conditions

Diabetic Foot; Ulcer; Diabetes Mellitus

Interventions

Cryopreservation; Standard of Care

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Endocrine System Diseases; Diabetic Neuropathies; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Tissue Preservation; Histocytological Preparation Techniques; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Preservation, Biological; Therapeutics; Investigative Techniques; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Charles I. Romano

  Amniox Medical, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2014
• First Posted: June 18, 2014
• Study Start: June 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: June 27, 2017

Record last verified: 2017-06

Locations

US (3)