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Table 3 Visit and treatment schedule

From: Safety and clinical efficacy of the secretome of stressed peripheral blood mononuclear cells in patients with diabetic foot ulcer—study protocol of the randomized, placebo-controlled, double-blind, multicenter, international phase II clinical trial MARSYAS II

Periods Enrollment/screening Allocation Active treatment Follow-up/close-out
Visits Visit 1 Visit 2 Visit 3 to visit 13 14 (EOT) 15 16 17
Days from randomization visit Days -14 to -28 (prior to active treatment) Day 0 Day 1 to day 28 Day 30 (± 5 days) Day 44 (± 2 days) Day 56 (± 2 days) Day 84 (± 5 days)
Enrollment
Informed consent X       
Inclusion/exclusion criteria X X      
Demography X       
Medical history X       
Concomitant medication X X X X X X X
Interventions
Randomization   X      
IMP application (verum)   X X     
IMP application (placebo)   X X     
Assessments
Physical examination and vital signs X X   X    X
Hematologya X       X
Serum chemistryb X       X
Urine analysisc X       X
Urine pregnancy test X X   X    
Wound assessment X X X X X X X
Assessment of wound closure X X X X X X X
Wound size measurement (eKare inSight®) X X X X X X X
Standard of care for wound management X X X X X X X
VAS—score for pain X X X X X X X
Neurological assessment foot   X   X    X
Chronic wound quality of life questionnaire   X   X    X
Recording adverse events   X X X X X X
  1. aErythrocytes/leucocytes/hemoglobin, hematocrit, thrombocytes, MCV, MCH, and MCHC
  2. bSodium, potassium, total protein, albumin, BUN, creatinine, glucose, Hba1c, AST, ALT, GGT, total bilirubin, and CRP
  3. cUrine dip stick: pH, nitrite, glucose, leucocyte, ketone, bilirubin, protein, and blood