AutoloGel Therapy to Usual and Customary Care in Pressure Ulcers (NCT01819142) | Clinical Trial Compass
TerminatedNot Applicable
AutoloGel Therapy to Usual and Customary Care in Pressure Ulcers
Stopped: Protocol study design was re-worked in collaboration with CMS
United States2 participantsStarted 2013-04
Plain-language summary
The aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, case-matched cohort-controlled trial in which pressure ulcers will be treated using AutoloGel and standard care and case-matched against a concurrent cohort of patients receiving undefined Usual and Customary Care.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Medicare/Medicaid eligible
✓. ≥18 years of age
✓. Ulcer of pressure/shear etiology (Stage II, III, and IV, see Appendix 9 for stage definitions)
✓. The largest non-healing wound, if multiple wounds are present, or the single wound to be treated (Index Ulcer) that is located on the heel, ischium, sacrum, and trochanter
✓. For subjects with potentially multiple eligible PUs, the largest ulcer will be selected.
✓. Debrided ulcer size between 3 cm2 and 200 cm2
✓. Demonstrated adequate offloading regimen
✓. Duration ≥ 1 month at first visit
Exclusion criteria
✕. Subjects known to be sensitive to AutoloGel components (calcium chloride, thrombin, ascorbic acid) and/or materials of bovine origin
✕. Stage I pressure ulcers
✕. Ulcers that are unstageable or of deep tissue morphology that have yet to become an open wound
✕. Presence of another wound that is concurrently treated and might interfere with treatment of index wound by AutoloGel
✕. Ulcer not of PU pathophysiology (e.g., pure diabetic, vasculitic, radiation, rheumatoid, collagen vascular disease, venous, or arterial etiology)