An interventional study of Artacent Human Amniotic Membrane and Standard of Care in Venous Ulcer and Foot Ulcer, Diabetic, sponsored by Tides Medical. Status unknown at 7 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-13.
Sponsored by Tides Medical · Not applicable, Interventional, and Treatment
This study will compare the proportion of patients who have wound closure within 12 weeks as well as the time to wound closure in patients receiving Artacent™ versus standard of care for treatment of non-healing lower extremity wounds. The recurrence of healed wounds will be assessed at 6 months via a telephone survey
This study is to document the efficacy of Artacent™ Human Amniotic Membrane (Artacent) in the treatment of diabetic and vascular lower extremity ulcers. The study will add to the currently available literature by also assessing the impact of treatment on quality of life and on heal economic outcomes. Finally the study will follow patients for longer than previous studies and will obtain data on healing and recurrence at 6 months.
The objectives of this study are 1) to compare Artacent to standard of care (SOC) in the treatment of non-healing lower extremity ulcers and 2) to evaluate the impact of treatment on patient quality of life. Health economic outcomes will also be collected. The proportion of patients receiving Artacent who have wound closure with 12 weeks will be compared to those patients receiving SOC only will be compared. A comparison of time to wound closure will also be compared between the two populations.
Patients who are randomized to the SOC group (control) and require further treatment at 12 weeks due to incomplete wound healing, may receive treatment with Artacent if the investigator determines that to be a potentially beneficial option.
378 studies on the registry are indexed under Varicose Ulcer; 80 are open to participants now.
This study's planned enrollment of 134 is above the median of 64 across 325 interventional studies indexed under Varicose Ulcer.
Browse Varicose Ulcer studies →Tides Medical is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients randomized to the Artacent group will receive standard of care (off-loading with a removable cast walker and non-adherent dressings in addition to debridement and use of moisture retentive dressing) and the application of the Artacent amniotic allograft once every two weeks for up to 5 applications or until the ulcer has healed.
Other: Artacent Human Amniotic Membrane
Patients randomized to standard of care will receive off-loading with a removable cast walker and non-adherent dressings (e.g. Adaptic) in addition to debridement and use of moisture retentive dressings. An outer dressing will also be applied.
Procedure: Standard of Care
Double layer dehydrated amnion product
Also known as: Amniotic tissue allograft, Amniotic placental membranes
Off loading with a cast walker, non-adherent dressings, debridement and moisture retentive dressings
Also known as: Debridement, Off-loading, non-adherent dressings
Wound closure
100% re-epithelialization of the wound without drainage or need for use of a dressing
Time frame: 12 weeks
Time to wound closure
# of days to 50% or greater closure
Time frame: 12 weeks
Ulcer recurrence
Telephone survey to capture number of ulcer recurrences and treatment
Time frame: 6 months
Quality of Life
EQ-5D survey
Time frame: 12 weeks
Impact of Treatment on Return to Work
Employment status e.g. full-time, part-time, retired, unemployed, etc.
Time frame: 12 weeks
Time to full weight bearing status
Ability of the subject to bear full weight and the time to full weight bearing
Time frame: 12 weeks
Adverse Events and Secondary Treatments
Time frame: 12 weeks
Number of grafts and graft size(s)
Number and size of grafts used at each application will be collected.
Time frame: 12 weeks
Health economic outcomes
Collection of de-identified Explanation of Benefits (EOB) and/or submitted claims and/or documentation of procedures via CPT coding.
Time frame: 12 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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