Pain in Chronic Leg- and Foot Ulcers
Unknown statusNCT03086577
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
Leg ulcers are a significant cause of impaired functional ability and quality of life for approximately 1-2 percent of the population in western countries. Although pain seems to be one of the most devastating aspects of living with a chronic ulcer, research is limited and there is a lack of knowledge about wound-related pain characteristics. Little is known about prevalence, pain intensity, qualities, location, temporal fluctuations, to witch degree pain impact on physical- and psychosocial functioning, as well as relieving and exacerbating factors. The overall purpose of this study is to investigate the prevalence and characteristics of wound related pain in patients with chronic leg ulcers. More specific research questions are: 1) What is the prevalence and characteristics of wound related pain in patients suffering from various types of persistent ulcers, 2) How do patients with different ulcer diagnoses report the quality of the wound related pain, 3) Is there any differences in wound pain characteristics among patients with different etiology leg ulcers, 4) How is the pain temporal pattern in patients with chronic leg- and foot ulcers, 5) What is the reported quality of life in patients with different ulcer diagnosis, and 6) Is there any association among pain characteristics, sleep and quality of life in patients with chronic leg/foot ulcers? The study has a non-experimental, explorative and descriptive approach. A cross-sectional questionnaire design will be used to explore patient's experience of wound-related pain. The patients will be recruited at the outpatient clinic appointment and home-care nursing in Norway. Participants will fill out self-report questionnaires. The battery of questionnaires will obtain information about demographic data, pain characteristics, quality of life and sleep. Pain characteristics, quality of life and sleep will be assessed by using different questionnaires that has demonstrated high validity and reliability. In addition, t…
Study details
- Official title
- Pain in Patients With Chronic Leg and Foot Ulcers - a Cross Sectional Study
- Conditions
- Leg Ulcer
- Pain
- Sponsor
- University College of Southeast Norway
- Collaborators
- Vestre Viken Hospital Trust
- Start date
- 2017-04-01
- Primary completion
- 2018-02-21
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Norway
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Leg- or foot ulcer that has persisted for more than 6 weeks Exclusion Criteria: * Psychological and cognitive restrictions that prohibit from providing informed consent, reading or writing disabilities * Inability to participate due to physical/psychological challenges, and inability to differentiate wound-related pain from other types of pain in the lower extremities. * The following ulcer-diagnosis will be excluded: Burn-ulcer, cancer-ulcer, radiation-ulcer, immunological ulcers and vasculitis ulcers.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03086577