Sponsor study identifier
observational
22
1 country
6
Study Start
July 15, 2020
Actual (reported)Primary Completion
February 21, 2022
Actual (reported)Study Completion
February 21, 2022
Actual (reported)This prospective study will compare incidence rates of complete hard-to-heal diabetic foot ulcer healing in Medicare beneficiaries following application of the 3C Patch® plus usual care, tested against a historical control group of similar patients that received usual care during a randomized controlled trial.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 21, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 21, 2019
Actual (reported)June 25, 2019
Actual (reported)July 15, 2020
Actual (reported)February 21, 2022
Actual (reported)February 21, 2022
Actual (reported)Complete healing
Rate (%) of complete healing of hard-to-heal diabetic foot ulcers in Medicare beneficiaries following application of the 3C Patch®.
within 20 weeks of the first application of the 3C Patch.
Number of 3C Patch® treatments administered
20 weeks
Major amputation - target limb
24 weeks
Major amputation - contralateral limb
24 weeks
Minor amputation - target limb
24 weeks
Minor amputation - contralateral limb
24 weeks
Medicare beneficiaries with diabetes and hard-to-heal non-healing ulcers of the foot will receive usual care (i.e., care consistent with the IWGDF guidance on use of interventions to enhance the healing of chronic ulcers of the foot in diabetes) supplemented by the application of the 3C Patch (A platelet-rich plasma gel patch comprised of distinct fibrin, platelet, and leukocyte substantially parallel layers, prepared without the use of any added reagents through a two-step centrifugation process)
A platelet-rich plasma gel patch comprised of distinct fibrin, platelet, and leukocyte substantially parallel layers, prepared without the use of any added reagents through a two-step centrifugation process
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Medicare beneficiaries diagnosed with diabetic foot ulcer
Mayo Clinic
Phoenix, Arizona, 84054, United States
Natchitoches Regional Medical Center
Natchitoches, Louisiana, 27514, United States
Opelousas General Hospital Wound Center
Opelousas, Louisiana, 70570, United States
Southeast Wound Care and Hyperbaric Medical Center
Cape Girardeau, Missouri, 63703, United States
Regional One Physician Specialists
Poplar Bluff, Missouri, 63901, United States
UNC Chapel Hill
Chapel Hill, North Carolina, 27514, United States
Game F, Jeffcoate W, Tarnow L, Jacobsen JL, Whitham DJ, Harrison EF, Ellender SJ, Fitzsimmons D, Londahl M; LeucoPatch II trial team. LeucoPatch system for the management of hard-to-heal diabetic foot ulcers in the UK, Denmark, and Sweden: an observer-masked, randomised controlled trial. Lancet Diabetes Endocrinol. 2018 Nov;6(11):870-878. doi: 10.1016/S2213-8587(18)30240-7. Epub 2018 Sep 19.
Londahl M, Tarnow L, Karlsmark T, Lundquist R, Nielsen AM, Michelsen M, Nilsson A, Zakrzewski M, Jorgensen B. Use of an autologous leucocyte and platelet-rich fibrin patch on hard-to-heal DFUs: a pilot study. J Wound Care. 2015 Apr;24(4):172-4, 176-8. doi: 10.12968/jowc.2015.24.4.172.
22 participants (actual enrollment reported by the registry).
First Submitted
June 21, 2019
First Posted
June 25, 2019
Study Start
July 15, 2020
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
February 21, 2022
Actual (reported)Study Completion
February 21, 2022
Actual (reported)Last Updated
March 9, 2022
Record last verified: 2022-02
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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