Study of Subjects With Diabetic Foot Ulcer (DFU)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-11

Study Completion Date

2017-12-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Deferoxamine on Wound Healing Rate in Patients With Diabetes Foot Ulcers

NCT03137966

Diabetic Foot Ulcer

NOT_YET_RECRUITING PHASE2

Open-Label Study in Diabetic Foot Ulcers (DFU), to Evaluate Safety of 0.03% DSC127 Topical Gel in Chronic Use

NCT01840085

Diabetic Foot Ulcer

TERMINATED PHASE3

Preventing Diabetic Foot Ulcers Through Cleaner Feet

NCT03503370

Diabetic Foot Ulcer

COMPLETED PHASE2

A Dose Finding Study of Topically Applied I-020201 as an Adjunct to Good Standard-of-care in Patients With Chronic Diabetic Foot Ulcers

NCT00915486

Diabetic Foot Ulcer

COMPLETED PHASE2

Efficacy of LL-37 Cream on Bacteria Colonization, Inflammation Response and Healing Rate of Diabetic Foot Ulcers

NCT04098562

Diabetic Foot Ulcer

UNKNOWN PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetic Foot

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No