Randomized Clinical Study Assessing NuShield Versus Standard of Care in Diabetic Foot Ulcers

NCT03855514 | Unknown

• 1 other identifier: 18-DFU-005-NUS
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 9

Brief Summary

This prospective, multi-center, randomized, controlled clinical study compares NuShield® plus SOC to SOC alone in subjects with chronic DFUs. NuShield® will be used along with standard of care on diabetic foot ulcers of greater than 6 weeks which have not adequately responded to conventional ulcer therapy.

Conditions

Diabetic Foot Ulcer

Keywords

DFU; Chronic Diabetic Foot Ulcer; Non-healing DFU

Outcome Measures

Primary Outcomes (1)

• Length of time that a wound achieves complete wound closure (CWC)

  Duration (number of days) to achieve CWC from baseline to week 12 assessed between both groups

  12 weeks

Secondary Outcomes (7)

• Greater than 40% wound closure at week 4 from baseline

  4 weeks

• Change in wound area

  12 weeks

• Incidence of prescribed pain and/or neuropathic medications

  12 weeks

• Reduction in subject reported pain at week 12 from baseline assessed between both groups via the Numeric Pain Rating Scale (NPRS)

  12 weeks

• Utilization of healthcare resources assessment

  12 weeks

Study Arms (2)

NuShield

ACTIVE COMPARATOR

NuShield® is a sterile, dehydrated placental allograft

Other: NuShield

Standard of Care

NO INTERVENTION

Standard of Care (SOC) includes, but is not limited to, surgical debridement, aggressive infection management, offloading, and maintenance of appropriate cleansing at the time of each dressing change.

Interventions

NuShield OTHER

NuShield® is a dehydrated placental allograft.

NuShield

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years old and maximum of 85 years old.
• Subjects with a diabetic foot ulcer that is either superficial, e.g. not involving tendon, capsule, or bone; or wounds that penetrate into tendon, capsule, bone and/or joint.
• Subjects, with the presence of Diabetes, must have a Glycosylated hemoglobin (HbA1c) ≤ 12% within 4 weeks prior to randomization
• Index ulcer (i.e. current episode of ulceration) has been present for greater than 4 weeks prior to the initial screening visit with no upper limit in duration of non-healing.
• Subject has adequate circulation to the foot as documented by either: Skin perfusion pressure (SPP) measurement of ≥ 45 mmHg, Toe-brachial index (TBI) ≥ 0.6/ Toe pressure greater than 40, Ankle-brachial index (ABI) between 0.60 and ≤ 1.3
• Index ulcer is a minimum of 0.5 cm2 and a maximum of 25cm2 at randomization, prior to first study treatment.
• The index ulcer has been offloaded for 14 days prior to randomization.
• Index ulcer has not reduced in area \> 20% from Day -14 to Day 0, prior to randomization.
• Subject understands and is willing to participate in the clinical study and can comply with weekly visits and the follow-up regimen.
• Subject, or their Legally Authorized Representative (LAR), has read, understood, and signed the IRB/IEC approved Informed Consent Form before screening procedures are undertaken.

You may not qualify if:

• Index ulcer(s) deemed by the investigator to be caused by a medical condition other than diabetes.
• Treatment with HBO wound dressings that include growth factors, bioengineered tissues, or skin substitutes within 30 days of randomization.
• History of bone cancer or metastatic disease of the affected limb or chemotherapy within the 12 months prior to randomization.
• Subjects with a history of more than two weeks treatment with immunosuppressants (including prednisone 10 mg daily or an equivalent does of other oral steroids cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within one month prior to first Screening Visit, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study.
• Subject is on any investigational drug(s) or therapeutic device(s) within 30 days preceding the first Screening Visit.
• History of radiation at the ulcer site.
• Index ulcer has been previously treated or will need to be treated with any prohibited therapies within 30 days prior to randomization.
• Presence of any condition(s) which seriously compromises the subject's ability to complete this study or has a known history of poor adherence with medical treatment.
• Active infection at the index ulcer at the time of Randomization.
• Acute osteomyelitis or bone infection of the affected foot, where subject has received less than 4 weeks of systemic antibiotics at the time of Screening and less than 6 weeks prior to Randomization (systemic antibiotic regimen must be completed at the time of Randomization).
• Subject's with suspected infection who have received less than 2 weeks of systemic antibiotics, or have not had surgical resection of clinically diagnosed osteomyelitis
• Subjects with suspected osteomyelitis who have not had an X-ray, CT scan or MRI within 14 days prior to Randomization.
• Subject is unwilling or unable to comply with the study requirement for offloading the index wound
• Subject is pregnant or breast feeding.

Sponsors & Collaborators

• Organogenesis: lead

Study Sites (9)

ILD Research Center

Carlsbad, California, 92002, United States

RECRUITING

Limb Preservation Platform

Fresno, California, 94063, United States

RECRUITING

University of Southern California

Los Angeles, California, 91208, United States

RECRUITING

Stanford University

Redwood City, California, 94063, United States

RECRUITING

Family Foot & Ankle Specialists

Bridgeport, Connecticut, 06606, United States

RECRUITING

Doctors Research Network

Miami, Florida, 33143, United States

RECRUITING

Extremity Healthcare

Roswell, Georgia, 30076, United States

RECRUITING

NYU Winthrop Hospital

New York, New York, 11501, United States

RECRUITING

Futuro Clinical Trials

McAllen, Texas, 78501, United States

RECRUITING

MeSH Terms

Conditions

Diabetic Foot

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

Study Officials

• Christine McLennan

  Organogenesis Inc.

  STUDY DIRECTOR

Central Study Contacts

Galen Hale

CONTACT

(205) 541-9682; GHale@organo.com

Andrea Black

CONTACT

(781) 830-2364; ABlack@organo.com

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 22, 2019
• First Posted: February 26, 2019
• Study Start: February 8, 2019
• Primary Completion: November 1, 2021
• Study Completion: December 30, 2021
• Last Updated: May 26, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)