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. 2021 Feb 18;11(2):e043420. doi: 10.1136/bmjopen-2020-043420

Table 1.

SPIRIT schedule of of enrolment, interventions and assessments

Visit 1
research nurse
Visit 2
research nurse
Email or phone contacts Visit 3
research nurse
Visit 4
research nurse
Timing Week −1 Week 0 Weeks 1–24 Week 12 Week 24
Case record form A B, M, Q   C, M, X C, H, M, Q, X
General data
 Eligibility criteria X X      
 Age and sex X        
 Ethnicity X        
 Informed consent X        
 Clinical history X        
 Record or obtain ABI X        
Clinical information
 Concomitant medications   X   X X
 Compression system   X   X  
 Ulcer measurement
(max W×L)
X X   X  
 Photograph ulcer   X   X X
 Ulcer healing       X X
Other data collection
 Ulcer-related pain to 12 weeks   X X X  
 Exercise adherence to 24 weeks     X   X
 Quality of life measures   X     X
 Ulcer-related infection       X X
 2-Minute Walk Test   X   X X
 Adverse events     X X X
 Health resource use         X
 End of trial participant survey         X
Treatment allocation
 Wound solution   X      
 Exercise programme   X      

ABI, Ankle Brachial Index; SPIRIT, Standard Protocol Items: Recommendations for Interventional Trials.