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Table 1 Study procedure schedule

From: Cellular versus acellular matrix devices in treatment of diabetic foot ulcers: study protocol for a comparative efficacy randomized controlled trial

Procedure Visit 1 (week −2) Visit 2 (week −1) Visit 3 (week 0), randomization Visits 4 to 10 (weeks 1 to 7), treatment (variable) Visits 11 to 14 (weeks 8 to 11), treatment Visit 15 (week 12), study endpoint Visits 16 to 19 (weeks 13 to 28), follow-up
Informed consent X       
Inclusion/exclusion criteria X X X     
Physical examination X      X  
Vital signs X X X X X X X
Ankle-brachial index X       
Fungal infection culture and malignancy evaluation X       
Blood sample drawn for laboratories X      X  
SF-36v2™ questionnaire X      X  
Ulcer assessment X X X X X X X
Debridement X X X X X X X
Ulcer photography and area measurement X X X X X X X
Randomization    X     
Dermagraft® Tx + SOC    X X    
Oasis® Tx + SOC    X X    
SOC and off-loading X X X X X X X
Concomitant medications and adverse events X X X X X X X
  1. Dermagraft® (Advanced BioHealing, Inc. La Jolla, California, United States), Oasis® (Healthpoint, Ltd, Fort Worth, Texas, United States). SF-36v2™, Short Form-36, version 2; SOC, standard of care; Tx, treatment.