Diabetic FootNCT03153007
Study of Subjects With Diabetic Foot Ulcer (DFU)
An observational study of Diabetic Foot, run by GlaxoSmithKline at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2017to 6 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Diabetic Foot
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of signs and symptoms, impacts on functioning and HRQoL among subjects with DFU
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.
Measured: Up to 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start11 Aug 2017
- Primary completion6 Dec 2017
- Study completion6 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ICON plc
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03153007
- Sponsor's protocol ID
- 207650
- Status last verified
- Aug 2018
- First submitted
- 11 May 2017
- Last updated
- 27 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qualitative Research in Patients With Diabetic Foot Ulcer
- ClinicalTrials.gov ID
- NCT03153007
- Acronym / sponsor ID
- 207650
- Conditions
- Diabetic Foot
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Collaborators
- ICON plc
- Study start
- 11 Aug 2017 (actual)
- Primary completion
- 6 Dec 2017 (actual)
- Study completion
- 6 Dec 2017 (actual)
- First posted
- 15 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2018.
- Results for study 207650 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
Related trials for Diabetic Foot
Recruiting
PAW-Hydrogel for Chronic Wound Healing
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Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
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Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Foot, run by GlaxoSmithKline at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of signs and symptoms, impacts on functioning and HRQoL among subjects with DFU (time frame: Up to 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2018.