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

NCT02707406 | Completed

• 1 other identifier: NE-2011
• Study Type: interventional
• Target: 124
• Locations: 2 countries
• Sites: 22

Brief Summary

The study is evaluating NEOX®CORD 1K, a cryopreserved human umbilical cord allograft. The purpose of the study is to evaluate the safety, incidence and rate of wound closure following application of the product compared to standard of care in the treatment of difficult to heal diabetic foot ulcers.

Conditions

Diabetic Foot Ulcers

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events collected throughout the trial compared between the two groups

  16 weeks

Secondary Outcomes (8)

• Proportion of subjects in NEOX® CORD 1KTM plus standard care against standard care with complete wound closure

  12 weeks from baseline

• Time in days to wound closure

  12 weeks from baseline

• Proportion of subjects with complete wound closure at each of the 12 treatment

  12 weeks from baseline

• Percent change in wound area (surface area cm2) at each visit compared to baseline (rate of wound closure)

  up to 15 weeks from baseline

• Percent change in wound volume (cm3) at each visit compared to baseline (rate of wound closure)

  up to 15 Weeks from baseline

Study Arms (2)

NEOX®CORD 1K

EXPERIMENTAL

Intervention Other: hct/p human cell or tissue product: NEOX®CORD 1K Intervention other: human tissue application of of NEOX®CORD 1K on subject wound

Other: NEOX®CORD 1K; Other: standard of care

Standard of Care

ACTIVE COMPARATOR

Intervention Other: standard of care alone Other intervention of Standard dressing with a non-adherent wound contact layer, a classic foam pad or gauze for moderately draining wounds, a secondary bandage, and institution of an investigator-approved off-loading device

Other: standard of care

Interventions

NEOX®CORD 1K OTHER

use of human tissue product wound covering

NEOX®CORD 1K

standard of care OTHER

standard wound coverings

NEOX®CORD 1K; Standard of Care

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• BioTissue Holdings, Inc: lead

Study Sites (22)

Unknown Facility

Carlsbad, California, United States

Location

Unknown Facility

Castro Valley, California, United States

Location

Unknown Facility

Fair Oaks, California, United States

Location

Unknown Facility

San Francisco, California, United States

Location

Unknown Facility

Sylmar, California, United States

Location

Unknown Facility

Washington D.C., District of Columbia, United States

Location

Unknown Facility

Miami, Florida, United States

Location

Unknown Facility

North Chicago, Illinois, United States

Location

Unknown Facility

New Orleans, Louisiana, United States

Location

Unknown Facility

Missoula, Montana, United States

Location

Unknown Facility

Las Vegas, Nevada, United States

Location

Unknown Facility

Eugene, Oregon, United States

Location

Unknown Facility

Portland, Oregon, United States

Location

Unknown Facility

Fort Worth, Texas, United States

Location

Unknown Facility

McAllen, Texas, United States

Location

Unknown Facility

San Antonio, Texas, United States

Location

Unknown Facility

Murray, Utah, United States

Location

Unknown Facility

Roanoke, Virginia, United States

Location

Unknown Facility

Virginia Beach, Virginia, United States

Location

Unknown Facility

Hamilton, Ontario, Canada

Location

Unknown Facility

London, Ontario, Canada

Location

Unknown Facility

Boucherville, Quebec, Canada

Location

MeSH Terms

Conditions

Diabetic Foot

Interventions

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; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

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

Study Record Dates

• First Submitted: February 25, 2016
• First Posted: March 14, 2016
• Study Start: February 1, 2016
• Primary Completion: April 14, 2017
• Study Completion: October 9, 2018
• Last Updated: June 28, 2019

Record last verified: 2019-06

Locations

US (19); CA (3)