An interventional study of AutoloGel in Venous Leg Ulcer, 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, cohort-controlled trial in which venous leg ulcers (VLU)n will be treated using AutoloGel and case-matched against a concurrent cohort of patients receiving undefined Usual and Customary Care (UCC)
Recurrence of ulcers in the leg is common; two-thirds of patients are likely to experience recurring ulcers after the first ulcer. While treatment of the underlying venous disease, depending on the mode of treatment, can lower the recurrence rate in many patients, it does not affect recurrence. AutoloGel is a platelet-rich plasma (PRP) gel used in the treatment of non-healing chronic wounds. The aim of this trial is to demonstrate the effectiveness, measured as complete wound healing, in a prospective, open-label trial in which venous leg ulcers will be treated using AutoloGel and standard of care and case-matched against a concurrent cohort of patients receiving undefined Usual and Customary Care
378 studies on the registry are indexed under Varicose Ulcer; 80 are open to participants now.
This study's enrollment of 2 is below the median of 64 across 325 interventional studies indexed under Varicose Ulcer.
Browse Varicose Ulcer studies →Cytomedix is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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 gel used in the treatment of non-healing wounds
Also known as: AutoloGel System
Time to wound closure
Primary endpoint is time to wound healing after 12 weeks com pared with case matched controls receiving standard of care. Complete wound closure is defined as skin re-epithelialization without drainage or dressing requirements confirmed at two consecutive study visits 2 weeks apart (FDA Guidance for Industry Chronic Cutaneous Ulcer and Burn Wounds - Developing Products for Treatment, 2006).
Time frame: 12 weeks
Proportion of wounds healed
Comparison of proportion of wounds healed over 12 weeks
Time frame: 12 weeks
Frequency of ulcer recurrence
Frequency of ulcer recurrence over a 1 year period post treatment; recurrence is defined as any new ulcer appearing on the leg after the index ulcer has healed.
Time frame: 1 year
Change in Quality of Life with Chronic Wounds (W-QOL) Score
Change in mean Quality of Life with Chronic Wounds (W-QOL) score between baseline and at 12 weeks
Time frame: 12 weeks
Number of patients with adverse events as a measure of tolerability
Frequency and severity of treatment emergent 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.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Cytomedix