A Prospective, Randomized, Controlled, Multi-Center, Study Evaluating AutoloGel Therapy for Compl… (NCT02248077) | Clinical Trial Compass
WithdrawnPhase 4
A Prospective, Randomized, Controlled, Multi-Center, Study Evaluating AutoloGel Therapy for Complete Closure of Wagner Grade 1-4 Diabetic Foot Ulcers, Venous Leg Ulcers and Stage II-IV Pressure Ulcers
Stopped: Study was redesigned in collaboration with CMS before it started.
0Started 2014-10
Plain-language summary
This study is designed to demonstrate the outcome of complete ulcer closure of patients with Wagner Grade 1-4 DFUs, VLUs or Stage II-IV PUs using AutoloGel versus Usual and Customary Care (UCC).
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 beneficiary
✓. Males or females ≥ 18 years of age
✓. Type I or II diabetes requiring medical treatment as determined by the physician
✓. The single wound to be applied Study Treatment (Index Ulcer) is a Wagner 1-4 DFU (see Section 17.12 Appendix 12 for Wagner Classification) that is located on the dorsal, plantar, medial, or lateral aspect of the foot (including all toe surfaces and the heel)
✓. Patients have been treated with UCC at the center for 2 weeks prior to randomization with no greater than 20% reduction in wound area or volume and documented wound measurements are available
✓. For patients with multiple potential Index 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 patient should not be enrolled (screen failure)
✓. Demonstrated offloading regimen
✓. A wound age of ≥ 30 days at the Screening Visit
Exclusion criteria
✕. Patients 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 the treatment of the Index wound