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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 30, 2019

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.

Interventions

  • Other: NuShield
    • NuShield® is a dehydrated placental allograft.

Arms, Groups and Cohorts

  • Active Comparator: NuShield
    • NuShield® is a sterile, 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • Incidence of wounds achieving CWC
    • Time Frame: 12 weeks
    • Frequency of wounds achieving CWC at week 12 from baseline assessed between both groups

Secondary Measures

  • 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
  • Change in wound area
    • Time Frame: 12 weeks
    • Mean percent change from baseline in wound area at Week 12
  • 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.
  • 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.
  • Utilization of healthcare resources assessment
    • Time Frame: 12 weeks
    • Utilization of healthcare resources through Week 12
  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Organogenesis
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Patrick Bilbo, Study Director, Organogenesis Inc.
  • Overall Contact(s)
    • Santina Wendling, (781) 401-1147, Wendling@organo.com

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