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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