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Table 2 Inclusion, exclusion and withdrawal criteria

From: Podoconiosis treatment in northern Ethiopia (GoLBet): study protocol for a randomised controlled trial

Inclusion criteria
1. Be at least 18-years old
2. Have provided informed consent
3. Have a diagnosis of at least Stage 2 podoconiosis (that is, podoconiosis lymphoedema) confirmed by the trial team
4. Have a negative ICT card test
5. Intends to remain within the area during the study period
Exclusion criteria
1. Already undertaking self-treatment comparable to the intervention
2. Nodular disease preventing use of shoes (will be referred for nodulectomy)
3. Complex wounds (will be referred for specialist care in Debre Markos Hospital)
4. Patient has a history of allergic reaction to treatment materials
5. Mental health or learning disorder affecting ability to adhere with treatment
6. Physical disability beyond podoconiosis precluding attendance at group sessions
7. Disease considered by the Trial Co-ordinator to affect ability to self-treat.
Withdrawal criteria
1. Wishes to withdraw consent to participate in trial
2. Move outside study Woreda
3. Experiences of SAEs considered by trial coordinator to compromise ability to participate
4. Experiences of SUSAR