Assessment of ankle edema

Ankle edema was assessed using clinical assessment and patient questionnaire. The clinical assessment method was done using an adapted technique described for evaluation of edema [23] and the scoring definitions have been changed to identify both the depth of oedema and recovery time of oedema. Pit depth was estimated visually and score recorded and recovery time was given in seconds as also described by Brodovicz et al. Edema assessment was repeated at the three anatomical locations described earlier. The pit depth was estimated visually and a score was given with 0 for no clinical edema, 1 for slight pitting up to 2 mm depth with no visible distortion and increasing in severity up to 4 for a very deep pit of 8 mm with gross distortion of extremity. Pitting edema score was noted as the total score of all 3 points.

Patient-reported edema was recorded using a standardized and validated questionnaire. It included five questions to assess the presence and severity of edema as reported by patients, over the past week with the highest score indicating maximum discomfort.

Adverse events were monitored in every clinic visit. The investigators determined severity, causality and the drug responsible for adverse event. Every adverse event was reported in the CRF and all serious adverse events were reported to the ethics committee and CDDA.