NuShield® is a dehydrated, sterile placental allograft (donor tissue transplant). This study is looking at the effectiveness of using both NuShield® together with current standard of care (SOC), compared to SOC alone on patients with chronic diabetic foot ulcers.
This is a multi-center, randomized, open label study which began on February 8th 2019 and is estimated to conclude on June 30th 2020. 125 participants with a diabetic foot ulcer ranging in size from 0.5cm2 and 25 cm2 will be studied.
Participants will be randomly allocated 1:1 to receive either NuShield® and SOC, or SOC alone following the 14 day screening period. Following this, subjects will be seen weekly for up to 24 weeks. Subjects that are placed into the SOC group, but whose diabetic foot ulcer has not healed by week 12 may be crossed over to receive NuShield® and followed for an additional 12-14 weeks.
- Subject must be at least 18 years old and a maximum of 85 years old.
- 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.
- Subject must have a Glycosylated hemoglobin (HbA1c) ≤ 10% within 4 weeks prior to the initial screening visit.
- 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.
- 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 mmHg.
- 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 first treatment visit.
- The index ulcer has been offloaded for at least 14 days prior to randomization.
- Subject must have a serum albumin level more than 3g/ DL total lymphocyte count of more than 1500/mm3
- Subject understands and is willing to participate in the clinical study and can comply with weekly visits and the follow-up regimen.
- Subject has read, understood, and signed the IRB/IEC approved Informed Consent Form before screening procedures are undertaken.
- Index ulcer(s) deemed by the investigator to be caused by a medical condition other than diabetes.
- 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).
- 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 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.
- Subjects 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).
- Subjects 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 unwilling or unable to comply with the study requirement for offloading the index ulcer
- Index ulcer has reduced in area by >20% within 2 weeks prior to randomization.
- Subjects on dialysis, with serum creatinine level ≥3.0 mg/dL and/ or a history of kidney transplant
This clinical trial is taking place in Carlsbad, California, United States. For more information about participating, please contact Irene Vayser on 760-350-5080 or firstname.lastname@example.org.
Sponsors / Collaborators
The sponsor of this study is Organogenesis. The study director is Patrick Bilbo of Organogenesis Inc.
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