Last updated: 10/06/2025 09:20:07
Study of subjects with diabetic foot ulcer (DFU)
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
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
- 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
Inclusion and exclusion criteria
Inclusion criteria:
- Adult male or female, 18 years of age or over
- Has a diagnosis of type 1 or 2 diabetes
- Has a diagnosis of neuropathic foot ulcer with minimal, if any, ischemia present (Ankle-Brachial Index [ABI] >=0.6 or transcutaneous oxygen [TcPO2] >35 millimeter of mercury [mmHg])
- Wagner grade 1 or 2
- Currently receiving treatment for a diagnosis of diabetic foot ulcer or have had an active foot ulcer healed within the last 6 months
- Is not currently enrolled in a clinical trial for DFU
- Is willing and able to provide informed consent indicating that they understand the purpose and procedures required for the study
- Is willing and able to participate in the study which includes a 60 minute interview
- Willing to have interview audio-recorded
- Speaks English as primary language
Exclusion criteria:
- Subjects who does not meet the inclusion criteria
- Has diagnosis of critical limb ischemia
- Has ulcers that have exposure of tendon, bone, or joint capsule (Wagner grade >2)
- Has osteomyelitis or gangrenous ulcers
- Is currently enrolled in a clinical trial for DFU
- Is unwilling or unable to sign an informed consent document indicating that they understand the purpose and procedures of the study
- Is unwilling or unable to participate in the study which includes an interview of up to 60 minutes in duration
Trial location(s)
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
Participate in clinical trial
Additional information
Results for study 207650 can be found on the GSK Clinical Study Register.
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