COMS for Chronic Ulcers Treatment

Percent wound area reduction

Percent wound area reduction (PWAR) at week 12 will be measured from pictures of the wound taken with ImitoWound research application. PWAR is computed as (Wound area at baseline - Wound area at 12 weeks) / Wound area at baseline. The picture of the wound will be taken after dressing removal, wound debridement (if applicable) and wound cleansing. ImitoWound research App will be used in an iPad as instructed in supplier's wound imaging and measurement guidelines. The camera of the iPad will be positioned 20 to 30 cm away from and parallel to the wound. A calibration marker (quick response \[QR\] code) will be positioned next to and in the same plane of the wound, and a photograph will be taken after recognition of the QR code by the Imito App, automatic wound measurement will take place. Study nurses will receive concise training and a working instruction with step-by-step procedure on how to use Imito App. (See Appendices) Each wound contour will then be checked and confirmed by an expe

Complete wound closure

1\) Complete wound closure after 8, 12, 16, 20, 24 weeks. Complete wound closure is defined as complete skin re-epithelialization without drainage confirmed by 2 consecutive trial visits 2 weeks apart

Percent Wound Area Reduction (PWAR

Percent Wound Area Reduction (PWAR) at week 4, 8, 16, 20, 24 will be measured from pictures of the wound taken with ImitoWound

Change in Pain assessment

Change in Pain assessment at week 12 vs. week 0 (VAS Scale). Patient's perception in terms of pain will be assessed using Visual Analog Scale (VAS) from 0 (no pain) to 10 (very strong pain). It will be asked the participant to use this scale to give a measure of general pain perceived prior to any treatment. The use of VAS offers a widespread potential to document the characteristics of disease-related symptoms (Gethin et al. 2014). Such scales are successfully used in the assessment of wound-related symptoms, are inexpensive and easily understood.

Change in Wound-QoL

4\) Change in Wound-QoL questionnaire at week 12 vs. week 0 (Wound-QoL). Wound-QoL is a short and easy-to-understand instrument to assess health related quality of life in patients with chronic wounds, especially leg ulcers. It consists of one page 17 Likert scaled items assessing impairments within the preceding seven days. Answers to each item are coded with numbers (0='not at all' to 4='very much'). A Wound-QoL-17 global score on overall disease-specific quality of life is computed by averaging all items. In addition, subscales of the Wound-QoL can be calculated representing different dimensions of disease-specific quality of life by averaging the respective items ("Body": items 1-5, "Psyche": items 6-10 and "Everyday life": items 11-16). Validated translations have been performed in French (France and Switzerland) and German (Germany, Austria and Switzerland).