Effectiveness of AutoloGel Therapy in Diabetic Foot Ulcers

Stopped early · Not applicable

Conditions studied: Diabetic Foot Ulcers

In brief

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 AutoloGel and case-matched against a concurrent cohort of patients receiving undefined Usual and Customary Care (UCC) as provided in up to 30 U.S. Wound Registry Research Network (USWRRN) centers.

Key facts

Study ID

NCT01816633

Run by

Cytomedix

People needed

3

Starts

2013-10-01

Expected to finish

2015-01-01

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
• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Arcadia, California, United States
• HyperBarxs at Northside Forsyth — Cumming, Georgia, United States

Full record on ClinicalTrials.gov

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