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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03855514
Recruitment Status : Recruiting
First Posted : February 26, 2019
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
Organogenesis

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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Other: NuShield Not Applicable

Detailed Description:

One hundred and twenty five (125) subjects with a chronic DFU ranging in size from 0.5cm2 and 25 cm2 will be randomized 1:1 to either NuShield® and SOC or SOC alone following the 14 day screening period. Following screening and randomization, subjects shall be seen weekly for up to 24 weeks. For subjects that heal prior to week 24, a healing confirmation visit shall occur two weeks later to confirm maintenance of complete wound closure.

Subjects that are randomized into the SOC group whose DFU has not healed by week 12 may be crossed over to receive NuShield® and followed for an additional 12-14 weeks.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, Randomized, Controlled Clinical Study Of NuShield® and Standard of Care (SOC) Compared to SOC Alone For The Management Of Diabetic Foot Ulcers
Actual Study Start Date : February 8, 2019
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: NuShield
NuShield® is a sterile, dehydrated placental allograft
Other: NuShield
NuShield® is a dehydrated placental allograft.

No Intervention: Standard of Care
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.



Primary Outcome Measures :
  1. Length of time that a wound achieves complete wound closure (CWC) [ Time Frame: 12 weeks ]
    Duration (number of days) to achieve CWC from baseline to week 12 assessed between both groups

  2. Incidence of wounds achieving CWC [ Time Frame: 12 weeks ]
    Frequency of wounds achieving CWC at week 12 from baseline assessed between both groups


Secondary Outcome Measures :
  1. Greater than 40% wound closure at week 4 from baseline [ Time Frame: 4 weeks ]
    Proportion of subjects achieving ≥ 40% wound closure at Week 4 from baseline

  2. Change in wound area [ Time Frame: 12 weeks ]
    Mean percent change from baseline in wound area at Week 12

  3. Incidence of prescribed pain and/or neuropathic medications [ Time Frame: 12 weeks ]
    Cumulative amount of pain and neuropathic medications taken between baseline and Week 12 assessed between both groups.

  4. Reduction in subject reported pain at week 12 from baseline assessed between both groups via the Numeric Pain Rating Scale (NPRS) [ Time Frame: 12 weeks ]
    Mean percent change at week 12 in subject reported pain, assessed via the NPRS pain scale where 0 = no pain and 10 = worst pain imaginable, on a scale of 0 to 10.

  5. Utilization of healthcare resources assessment [ Time Frame: 12 weeks ]
    Utilization of healthcare resources through Week 12

  6. Improvement in subject reported quality of life at week 12 from baseline assessed via the Wound-QoL (Questionnaire on quality of life with chronic wounds). [ Time Frame: 12 weeks ]
    Mean percent change at week 12 from baseline in subject reported quality of life scores between both groups. The 17 item Wound-QoL tool measures the disease-specific, health-related quality of life of patients with chronic wounds. A global score is computed by averaging all 17 items where subjects answer each question on a scale of 0 to 4, where 0=not at all and 4=very much.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject must be at least 18 years old and a maximum of 85 years old.
  2. Subjects with diabetic foot ulcers which extend into the papillary (shallow) dermis, or into the reticular (deep) dermis, or into subcutaneous fat, but not extending into muscle, tendon, capsule, or bone.
  3. Subject must have a Glycosylated hemoglobin (HbA1c) ≤ 10% within 4 weeks prior to the initial screening visit.
  4. Index ulcer (i.e. current episode of ulceration) has been present for greater than 4 weeks prior to the initial screening visit and less than 1 year.
  5. Subject has adequate circulation to the foot as documented by either:

    1. Skin perfusion pressure (SPP) measurement of ≥ 45 mmHg.
    2. Toe-brachial index (TBI) ≥ 0.6/ Toe pressure greater than 40 mmHg.
    3. Ankle-brachial index (ABI) between 0.60 and ≤ 1.3
  6. Index ulcer is a minimum of 0.5 cm2 and a maximum of 25cm2 at first treatment visit.
  7. The index ulcer has been offloaded for at least 14 days prior to randomization.
  8. Subject must have a serum albumin level more than 3g/ DL total lymphocyte count of more than 1500/mm3
  9. Subject understands and is willing to participate in the clinical study and can comply with weekly visits and the follow-up regimen.
  10. Subject has read, understood, and signed the IRB/IEC approved Informed Consent Form before screening procedures are undertaken.

Exclusion Criteria:

  1. Index ulcer(s) deemed by the investigator to be caused by a medical condition other than diabetes.
  2. Treatment with wound dressings that include growth factors, bioengineered tissues, or skin substitutes within 30 days of the Screening visit and throughout the study (with the exception of skin substitutes containing antimicrobials which are excluded from the Screening visit and throughout the study).
  3. History of bone cancer or metastatic disease of the affected limb or chemotherapy within the 12 months prior to randomization.
  4. Subjects with a history of more than two weeks treatment with immunosuppressant's (including systemic corticosteroids > 10mg daily), 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.
  5. Subjects on any investigational drug(s) or therapeutic device(s) within 30 days preceding the first Screening Visit.
  6. History of radiation at the ulcer site.
  7. Index ulcer has been previously treated or will need to be treated with any prohibited therapies within 30 days prior to randomization.
  8. 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.
  9. Active infection at the index ulcer at the time of Randomization.
  10. 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).
  11. Subjects with suspected infection who have received less than 2 weeks of systemic antibiotics or have not had surgical resection of clinically diagnosed osteomyelitis
  12. Subjects with suspected osteomyelitis who have not had an X-ray, CT scan or MRI within 14 days prior to Randomization.
  13. Subject unwilling or unable to comply with the study requirement for offloading the index ulcer
  14. Index ulcer has reduced in area by >20% within 2 weeks prior to randomization.
  15. Subjects on dialysis, with serum creatinine level ≥3.0 mg/dL and/ or a history of kidney transplant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03855514


Contacts
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Contact: Santina Wendling (781) 401-1147 Wendling@organo.com
Contact: Jennifer DiNardo (781) 615-1651 jdinardo@organo.com

Locations
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United States, California
ILD Research Center Recruiting
Carlsbad, California, United States, 92009
Contact: Irene Vayser    760-350-5080    irene vayser <irene@ildresearch.com>   
Principal Investigator: Dean Vayser, DPM         
Sponsors and Collaborators
Organogenesis
Investigators
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Study Director: Patrick Bilbo Organogenesis Inc.
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Responsible Party: Organogenesis
ClinicalTrials.gov Identifier: NCT03855514    
Other Study ID Numbers: 18-DFU-005-NUS
First Posted: February 26, 2019    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Organogenesis:
DFU
Chronic Diabetic Foot Ulcer
Non-healing DFU
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases