AutoloGel Therapy to Usual and Customary Care in Pressure Ulcers

Stopped early · Not applicable

Conditions studied: Pressure Ulcer

In brief

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.

Key facts

Study ID

NCT01819142

Run by

Cytomedix

People needed

2

Starts

2013-04-01

Expected to finish

2016-01-01

Last updated by the study team

2016-10-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• There must be at least 4 cm between the Index Ulcer and other ulcers; if all ulcers are closer than 4 cm, the subject should not be enrolled (screen failure)
• Debrided ulcer size between 3 cm2 and 200 cm2
• Demonstrated adequate offloading regimen
• Duration ≥ 1 month at first visit
• Subject must be willing to comply with the Protocol, which will be assessed by enrolling clinician.

You may not qualify if…

• 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)
• Any malignancy other than non-melanoma skin cancer
• Subjects who are cognitively impaired and do not have a healthcare proxy
• Serum albumin of less than 2.5 g/dL
• Plasma Platelet count of less than 100 x 109/L
• Hemoglobin of less than 10.5 g/dL
• Subject has inadequate venous access for repeated blood draw required for AutoloGel Administration.
• Life expectancy of < 6 months.

Where it is running

• Singing River — Pascagaula, Mississippi, United States

Full record on ClinicalTrials.gov

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