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

Table 1 Endpoints

	Endpoint details
Primary endpoint	Cumulative incidence of ADLA (total number of incident episodes over the 12-month follow-up period).
Secondary endpoints	Adherence to treatment
	Foot washing, use of ointment, use of bandages, elevation, exercises, use of socks and shoes.
	Clinical outcomes:
	Clinical stage of disease^a
	Lower leg and foot circumferences^b
	Presence of mossy changes
	Wounds and inter-digital lesions;
	Duration of ADLA days
	Social outcomes:
	Quality of life^c
	Perceived stigma^d
	Economic outcomes:
	Economic productivity^e

ADLA, acute dermatolymphangioadenitis
^aUsing a scale specifically developed for use in podoconiosis patients [22]
^bMeasured in centimetres at mid-calf and mid-foot
^cUsing validated Amharic translation of Dermatology Life Quality Index [23] and WHO Disability Assessment Schedule-II (WHODAS-II)
^dUsing scale developed to measure stigma among podoconiosis patients (24)
^eOther measures of economic vulnerability found to be related to podoconiosis in economic context survey

ISSN: 1745-6215