Status:
TERMINATED
AutoloGel Therapy to Usual and Customary Care in Pressure Ulcers
Lead Sponsor:
Cytomedix
Conditions:
Pressure Ulcer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 Au...
Detailed Description
Pressure ulcers (PUs) are a common problem in all patient care settings, especially long-term acute care facilities and nursing homes. AutoloGel is a platelet-rich plasma gel used in the treatment of ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 10\. Life expectancy of \< 6 months.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01819142
Start Date
April 1 2013
End Date
January 1 2016
Last Update
October 21 2016
Active Locations (1)
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1
Singing River
Pascagaula, Mississippi, United States