Last updated: 10/06/2025 09:20:07

Study of subjects with diabetic foot ulcer (DFU)

GSK study ID
207650
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Qualitative Research in Patients with Diabetic Foot Ulcer
Trial description: Foot ulceration is a common and costly complication of diabetes. GSK1278863 is a topical drug, which is being developed to treat wounds associated with DFU. The aim of this study is to explore the symptoms and impacts of DFU from the subject perspective and to elicit in-depth information about DFU signs and symptoms, impacts on functioning and health-related quality of life (HRQoL). Adult DFU subjects with current or recent (within last six months) neuropathic foot ulcers will be eligible to participate in this prospective, cross-sectional interview study. Approximately 20 DFU subjects will be recruited from up to three clinical sites. Potential subjects will be pre-screened and then contacted to gauge interest in the study. Interested subjects will be screened and eligible subjects will consent to release contact information to research staff. Research staff will contact the subject to schedule interviews. This study will include concept elicitation interviews over the telephone or in-person by trained and experienced interviewers. In-person interviews will be conducted in a private room at the clinical site. All interviews will be conducted in English and will be guided by semi-structured interview guides. All subjects will provide written consent prior to the start of the interview.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Assessment of signs and symptoms, impacts on functioning and HRQoL among subjects with DFU

Timeframe: Up to 60 minutes

Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
1
Primary completion date:
2017-06-12
Observational study model:
Case-Only
Time perspective:
Cross-Sectional
Clinical publications:
Tony Okoro, Vanja Sikirica, Linda Casillas, Triza Brion, Jacob Devine, Vivien Ong, Kellee Howard. Elicitation of disease concepts in patients with diabetic foot ulcers: a qualitative study. J Wound Care. 2020;29(5):S38 – S45 DOI: 10.12968/jowc.2020.29.Sup5a.S38 PubMed Id: 32412892
Medical condition
Diabetic Foot
Product
daprodustat
Collaborators
ICON
Study date(s)
August 2017 to December 2017
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • Adult male or female, 18 years of age or over
  • Has a diagnosis of type 1 or 2 diabetes
  • Subjects who does not meet the inclusion criteria
  • Has diagnosis of critical limb ischemia

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Bethesda, Maryland, United States, 20814
Status
Study Complete

Study documents

Protocol
Available language(s): English
Scientific result summary
Available language(s): English

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Study complete
Actual primary completion date
2017-06-12
Actual study completion date
2017-06-12

Plain language summaries

Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

Additional information about the trial

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Additional information
Results for study 207650 can be found on the GSK Clinical Study Register.
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