An interventional study of AutoloGel in Diabetic Foot Ulcers, sponsored by Cytomedix. Terminated at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-10-21.
Sponsored by Cytomedix · Not applicable, Interventional, and Treatment
The aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, case-matched cohort trial in which diabetic foot ulcers (DFU) will be treated using AutoloGel and case-matched against a concurrent cohort of patients receiving undefined Usual and Customary Care (UCC) as provided in up to 30 U.S. Wound Registry Research Network (USWRRN) centers.
AutoloGel is a platelet-rich plasma gel used in the treatment of non-healing chronic wounds. Prospective observational studies of the effectiveness of AutoloGel have demonstrated promising results in regard to the healing of DFUs, including severe Wagner grade 3 and 4 ulcers. The aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, case-matched cohort trial in which diabetic foot ulcers will be treated using AutoloGel to determine the time to heal at 12 weeks. Comparison will be made with a case-matched concurrent cohort of patients receiving undefined Usual and Customary Care (UCC).
1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's enrollment of 3 is below the median of 60 across 826 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →Cytomedix is the lead sponsor of 6 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Subjects will be treated on average twice a week for the first 2 weeks, and then, once a week thereafter while under active treatment, but actual frequency of treatment will be determined by the treating physician. All subjects will receive AutoloGel treatment.
Device: AutoloGel
AutoloGel is a platelet-rich plasma (PRP) gel used in the treatment of non-healing chronic wounds. It will be administered twice weekly for 2 weeks then weekly
Time to heal
The primary objective of the trial is to determine the time to heal diabetic foot ulcers treated with Autologel and Standard of Care at 12 weeks DFUs. Comparison will be made with a concurrent cohort of case matched subjects
Time frame: 12 weeks
Ulcer recurrence
Frequency of ulcer recurrence defined as any new ulcer appearing after the index ulcer healed
Time frame: 1 year
Incidence of amputations
Frequency of lower extremity amputations; major/minor amputations will be tabulated but not tested.
Time frame: 1 year
Proportion of completely healed ulcers
Proportion of patients with completely healed diabetic foot ulcers
Time frame: 12 weeks
W-QOL (Quality of life with Chronic Wounds) score
Change in mean W-QOL (Quality of life with Chronic Wounds) score between baseline and 12 weeks
Time frame: 12 weeks
Number of patients with adverse events as a measure of tolerability
Frequency and severity of adverse events
Time frame: 12 weeks
This study is terminated, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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Cytomedix