Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2020-09-15
2022-03-01
Brief Summary
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Detailed Description
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To gain insight into these questions Podimetrics researchers will be conducting a longitudinal study among patients suffering with a DFU. The general purpose of the study is to evaluate the current quality of life of DFU patients from the subject perspective in various domains including physical functioning, general health perception, psychological, social functioning, vitality and role limitations. The study will also explore the relationships between HRQoL and usage of the Podimetrics System. Improved understanding of patients' subjective evaluation of their quality of life, and the role of the Podimetrics System, will help clinicians provide better care for these patients.
A cohort of DFU patients will be recruited upon providing informed consent. Participant lifestyle and ulcer status information is collected by a background survey. HRQoL is assessed at baseline, 6 month and 12 month using questionnaires. The investigators intend to use two types of questionnaires for HRQoL evaluation in this study: one generic questionnaire, SF-36, which addresses general quality of life issues, and one specific questionnaire, DFS-SF, which addresses issues specific to diabetic foot diseases, such as ulcer severity and impact of ulcer care.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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DFU Participants
A cohort of 200 DFU patients who have been prescribed the Podimetrics System by their healthcare providers will be recruited upon providing informed consent. Potential participants will be asked to indicate their interest in participating in this patient empowerment study during their initial phone consultation for mat set-up with the Podimetrics care-management team. Participants will be followed for one year and answer a set of identical questionnaires at three time points: at baseline, at 6-month and at 12-month post enrollment.
No intervention, this is an observational study
No intervention
Interventions
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No intervention, this is an observational study
No intervention
Eligibility Criteria
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Inclusion Criteria
* Have history of one or more foot ulcers in the lower extremities (by verbal history from the participant)
* Have been prescribed the Podimetrics RTM System in the last 30 days
* Not be pregnant (by verbal history from the participant)
* Be mentally lucid
* Be able to read and write English
* Provide informed consent
Exclusion Criteria
* Unable to understand English
* Unable to complete questionnaires due to visual or upper extremity impairments
* Unable to provide consent
* Other issues that, at the discretion of the investigator, renders the subject ineligible for participation
18 Years
ALL
No
Sponsors
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Podimetrics, Inc.
INDUSTRY
Responsible Party
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Locations
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Podimetrics,Inc.
Somerville, Massachusetts, United States
Countries
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Central Contacts
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Other Identifiers
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PCRT-0068
Identifier Type: -
Identifier Source: org_study_id
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