Status:
TERMINATED
Effectiveness of AutoloGel Therapy in Diabetic Foot Ulcers
Lead Sponsor:
Cytomedix
Conditions:
Diabetic Foot Ulcers
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 trial in which diabetic foot ulcers (DFU) will be treated using Au...
Detailed Description
AutoloGel is a platelet-rich plasma gel used in the treatment of non-healing chronic wounds. Prospective observational studies of the effectiveness of AutoloGel have demonstrated promising results in ...
Eligibility Criteria
Inclusion
- Medicare/Medicaid eligible
- ≥18 years of age
- Type I or II diabetes requiring medical treatment as determined by the physician
- The largest non-healing wound, if multiple wounds are present, or the single wound to be treated (Index Ulcer) is a Wagner 1-5 DFU (see Appendix 9 for Wagner Classification) that is located on the dorsal, plantar, medial, or lateral aspect of the foot or heel (including all toe surfaces)
- For subjects with potentially multiple eligible DFUs, 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 0.5 cm2 and 50 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
- Presence of another wound that is concurrently treated and might interfere with treatment of the index wound by AutoloGel (malignancy in nearby wound)
- Ulcer not of DFU pathophysiology (e.g., venous, vasculitic, radiation, rheumatoid, collagen vascular disease, pressure, 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.
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT01816633
Start Date
October 1 2013
End Date
January 1 2015
Last Update
October 21 2016
Active Locations (2)
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1
Arcadia, California, United States, 91007
2
HyperBarxs at Northside Forsyth
Cumming, Georgia, United States