The purpose of this study was to develop and validate a questionnaire to measure the impact of chronic wounds (leg ulcers and diabetic foot ulcers) on patient health-related quality of life (HRQoL) and identify areas of patient concern. The Cardiff Wound Impact Schedule (CWIS) was created following a three-stage process. Stage 1 included a focus group (n=10) and a series of semi-structured interviews (n=13) to generate items for the questionnaire. Stage 2 involved piloting the 28-item questionnaire on 124 patients (64.5% with leg ulceration and 35.5% with diabetic foot ulceration): data from this stage were analysed using factor analysis. The reliability, validity and reproducibility of the resulting scale were assessed in Stage 3, a 3-month follow-up study of 135 patients in which patients completed the CWIS and the SF-36. Factor analysis identified three domains of HRQoL: physical symptoms and daily living, social life and well-being. There were no significant differences in scores across the wound types. Internal consistency was good (alpha=0.77-0.96) as was reproducibility (P<0.001). The CWIS was able to discriminate between those with healed ulcers and active ulcers (P<0.01). Construct validity was demonstrated by strong correlations between related items on CWIS and SF-36 (P<0.01-P<0.0001). The data suggest that CWIS has high internal consistency and the ability to discriminate between health states and good reproducibility. CWIS is a valid tool for studying the impact of chronic wounds of the lower leg on HRQoL. CWIS allows clinicians to identify items of patient concern, which can then be used to negotiate options of care most suited to individual patients.