Study of Subjects With Diabetic Foot Ulcer (DFU)

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.

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Key information

Conditions

Diabetic Foot Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site

Bethesda, Maryland, 20814, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Collaborators

ICON plc

Registry information

Official study title

Qualitative Research in Patients With Diabetic Foot Ulcer

Important dates

Study start: 2017
Primary completion: 2017
Study completion: 2017
First posted: May 15, 2017
Registry last updated: Aug 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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