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 |