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Trial record 50 of 417 for:    Foot Diseases | "Diabetic Foot"

Study of Subjects With Diabetic Foot Ulcer (DFU)

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ClinicalTrials.gov Identifier: NCT03153007
Recruitment Status : Completed
First Posted : May 15, 2017
Last Update Posted : January 18, 2018
Sponsor:
Collaborator:
ICON plc
Information provided by (Responsible Party):
GlaxoSmithKline

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.

Condition or disease
Diabetic Foot

Study Type : Observational
Actual Enrollment : 1 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Qualitative Research in Patients With Diabetic Foot Ulcer
Actual Study Start Date : August 11, 2017
Actual Primary Completion Date : December 6, 2017
Actual Study Completion Date : December 6, 2017

Resource links provided by the National Library of Medicine


Group/Cohort
Subjects with DFU
Adult male or female subjects, 18 years of age or over and currently receiving treatment for a diagnosis of DFU or have received treatment for a past foot ulcer within the last 6 months, will be recruited from up to three clinical sites. They will undergo concept elicitation interviews over the telephone or in-person by trained and experienced interviewers.



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03153007


Locations
United States, Maryland
GSK Investigational Site
Bethesda, Maryland, United States, 20814
Sponsors and Collaborators
GlaxoSmithKline
ICON plc
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03153007     History of Changes
Other Study ID Numbers: 207650
First Posted: May 15, 2017    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetic Foot
Foot Ulcer
Vascular Diseases
Cardiovascular Diseases
Skin Diseases
Endocrine System Diseases
Foot Diseases
Diabetic Angiopathies
Leg Ulcer
Skin Ulcer
Diabetes Complications
Diabetes Mellitus
Diabetic Neuropathies