Clinical trial NCT03153007: Study of Subjects With Diabetic Foot Ulcer (DFU)
Official title: Qualitative Research in Patients With Diabetic Foot Ulcer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Foot
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: ICON plc
First posted: 2017-05-15
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 20 DFU adult male or female subjects, 18 years of age or over, with current or recent (within last six months) neuropathic foot ulcers will be recruited from up to three clinical sites

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Assessment of signs and symptoms, impacts on functioning and HRQoL among subjects with DFU
timeFrame: Up to 60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: GSK Investigational Site
state: Maryland
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: