Study of Subjects With Diabetic Foot Ulcer (DFU)
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|ClinicalTrials.gov Identifier: NCT03153007|
Recruitment Status : Completed
First Posted : May 15, 2017
Last Update Posted : August 27, 2018
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||1 participants|
|Official Title:||Qualitative Research in Patients With Diabetic Foot Ulcer|
|Actual Study Start Date :||August 11, 2017|
|Actual Primary Completion Date :||December 6, 2017|
|Actual Study Completion Date :||December 6, 2017|
Subjects with DFU
Adult male or female subjects, 18 years of age or over and currently receiving treatment for a diagnosis of DFU or have received treatment for a past foot ulcer within the last 6 months, will be recruited from up to three clinical sites. They will undergo concept elicitation interviews over the telephone or in-person by trained and experienced interviewers.
- Assessment of signs and symptoms, impacts on functioning and HRQoL among subjects with DFU [ Time Frame: Up to 60 minutes ]An iterative and thematic analytic approach will be applied to the concept elicitation data in order to identify key concepts related to DFU signs and symptoms, impacts on functioning and HRQoL. Concepts that emerge from the analysis will be tracked using a saturation matrix and will be recorded until saturation is attained, or at the point when no new concepts have emerged from the data. Transcripts produced from the subject and expert interview audio recordings will be analyzed using qualitative analysis software in order to identify themes emerging from the data while accounting for information gleaned from the review of literature.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03153007
|United States, Maryland|
|GSK Investigational Site|
|Bethesda, Maryland, United States, 20814|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|