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Table 1 Schedule of study procedures

From: The evaluation of off-loading using a new removable oRTHOsis in DIABetic foot (ORTHODIAB) randomized controlled trial: study design and rationale

 

Inclusion and randomization

Casting and measurements

Delivery of the offloading device

Follow-up

Visits

V1

V2

V3

V4

V5

V6

V7

Weeks*

0

1

2

6

10

14

26

Verification of the inclusion or non-inclusion criteria

x

      

Patient Education and signature of the consent

x

      

Collection of demographic and clinical dataa

x

      

Collection of the diabetes historyb

x

      

Collection of the past medical historyc

x

      

Collection of adverse events

 

x

x

x

x

x

x

Collection of the current treatments

x

 

x

x

x

x

x

Clinical examinationd

x

      

Biological measurementse

x

      

Podiatric examination

x

      

Evaluation of the principal ulcer

x

 

x

x

x

x

x

Local wound care

x

x

x

x

x

x

x

Evaluation of concomitant ulcer(s)

x

 

x

x

x

x

x

Randomization

x

      

Taking photographs of the ulcer(s)

x

 

x

x

x

x

x

Sending the photographs to UMANIS

x

 

x

x

x

x

x

Collection of podological complications

  

x

x

x

x

x

Appearance of new ulcer(s)

  

x

x

x

x

x

Delivery the off-loading device

  

x

    

Verification of the off-loading quality

   

x

x

x

x

Wearing frequency of the device

   

x

x

x

x

Obtaining an appointment

x

x

x

x

x

x

 
  1. *Weeks ± 3 days; aage, sex, profession and history of tobacco smoking; bType, duration and complications of diabetes; cHistory of podiatric, medical and surgical disease; dWeight, height, heart rate, systolic and diastolic blood pressure, and podological examination; eHbA1c, plasmatic creatinine, estimated Glomerular Filtration Rate computed by the Chronic Kidney Disease Epidemiology Collaboration equation, and urinary albumin-creatinine ratio