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.