Randomized Clinical Study Assessing NuShield Versus Standard of Care in Diabetic Foot Ulcers (DFUs)
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|ClinicalTrials.gov Identifier: NCT03855514|
Recruitment Status : Recruiting
First Posted : February 26, 2019
Last Update Posted : May 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Foot Ulcer||Other: NuShield||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||125 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Active Comparator: NuShield
NuShield® is a sterile, dehydrated placental allograft
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.
- 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
- 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.
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
|Contact: Santina Wendling||(781) 401-1147||Wendling@organo.com|
|Contact: Jennifer DiNardo||(781) firstname.lastname@example.org|
|United States, California|
|ILD Research Center||Recruiting|
|Carlsbad, California, United States, 92009|
|Contact: Irene Vayser 760-350-5080 irene vayser <email@example.com>|
|Principal Investigator: Dean Vayser, DPM|
|Study Director:||Patrick Bilbo||Organogenesis Inc.|