Study of Subjects With Diabetic Foot Ulcer (DFU)
| Status: | Completed |
|---|---|
| Conditions: | Podiatry, Diabetes |
| Therapuetic Areas: | Endocrinology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/29/2018 |
| Start Date: | August 11, 2017 |
| End Date: | December 6, 2017 |
Qualitative Research in Patients With Diabetic Foot Ulcer
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.
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.
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
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