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Table 1 Schedule of activities

From: Double blind, randomized, placebo controlled clinical trial for the treatment of diabetic foot ulcers, using a nitric oxide releasing patch: PATHON

 

Follow-up visits

PROTOCOL ACTIVITIES

Screening Visit

Initial Visit

Visit 1

Visit 2

Visit 3

Visit 4

Visit 5

Final Visit

SCHEDULE OF VISITS

 

0

15 ± 5

30 ± 5

45 ± 5

60 ± 5

75 ± 5

90 ± 5

Clinical History

X

X

X

X

X

X

X

X

Physical Examination

X

X

X

X

X

X

X

X

Inclusion/Exclusion criteria

X

       

Informed Consent

X

       

Clinical assessment of vascular compromise

X

X

X

X

X

X

X

X

Clinical assessment of neuropathic compromise

 

X

     

X

Laboratory tests

 

X

     

X

Ankle/arm index

X

       

Randomization

 

X

      

Treatment administration

 

X

X

X

X

X

X

 

Clinical assessment of the lesion

X

X

X

X

X

X

X

X

Measurement of ulcers

X

X

X

X

X

X

X

X

Photographic registration

 

X

X

X

X

X

X

X

Education of patients

X

X

X

X

X

X

X

X

Documentation of adverse events

X

X

X

X

X

X

X

X

Recording of concomitant medications

X

X

X

X

X

X

X

X

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Trials

ISSN: 1745-6215