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Table 1 Study Schedule

From: Protocol for a pilot randomised controlled clinical trial to compare the effectiveness of a graduated three layer straight tubular bandaging system when compared to a standard short stretch compression bandaging system in the management of people with venous ulceration: 3VSS2008

 

Screening

Period

Treatment Period

Weeks

Follow-Up Period

Months

 

Screening

visit

Day

1

1

2

3

4

5

6

7

8

9

10

11

12

Month1

Month2

Month3

Informed Consent

X

                

Inclusion Criteria

X

                

Exclusion Criteria

X

                

Randomisation

X

                

Medical history

X

                

Physical Examination

X

            

X

X

X

X

Vital Signs

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

Intercurrent Illness

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

Intercurrent Medication

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

Tolerability Assessment

 

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

Target ulcer assessment

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

SF 36 and CWIS

 

X

           

X

  

X

Adverse events

 

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

Compression hosiery fitting/ application

X

            

X2

   

Check for Ulcer Recurrence

              

X

X

X

Care of ulcer information sheet

X

            

X2

X4

X4

X4

Referred back to specialty wound clinic

             

X3

X4

X4

X4

  1. X2: If healed.
  2. X3: If not healed.
  3. X4: If ulcer has recurred.
  4. *: If target ulcer has completely healed, (defined as 100% epithelialisation with no presence of exudate or scab).