Clinical trial NCT04537676: Patient Empowerment Study
Official title: Patient Empowerment Study: Assessment of Quality of Life Among Patients With Diabetes Foot Ulcer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetic Foot
Quality of Life
Mental Health Wellness 1
Ulcer Foot
Diabetes Complications
Keywords: Diabetic Foot
Quality of Life
Foot Ulcer
Lead sponsor: Podimetrics, Inc.
Sponsor class: INDUSTRY
First posted: 2020-09-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Two hundred (200) patients who have been prescribed the Podimetrics Remote Temperature Monitoring System (hereafter "Podimetrics System") by their healthcare providers will be recruited. 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 recruited based on the requirements indicated below. A Podimetrics representative will confirm that each participant meets the requirements by evaluation through a brief interview after participants indicate their interest and provide oral consent. This study will exclude anyone with a cognitive impairment that would disqualify them from providing informed consent.

Brief summary: The Patient Empowerment Study is an observational longitudinal study among adults with diabetic foot ulcer (DFU). The scope of this study is to better understand how a patient's DFU disease process and usage of the Podimetrics System can impact patient health-related quality of life. Health-related quality of life will be measured by both the generic 36-item Short-Form Health Survey (SF-36) questionnaire and the ulcer-specific Diabetic Foot Ulcer Scale Short Form (DFS-SF) questionnaire.

Detailed description: There is emerging evidence that diabetic foot complications greatly affect the quality of life of patients and cause people a significant burden to life. A diabetic foot ulcer (DFU) is associated with deterioration the physical, mental and social life quality. Given the detrimental effect foot ulcers have on patients, it is essential that quality of life metrics be evaluated among DFU patients. To what degree can diabetic foot ulcers affect the quality of life of patients? What are the facilitators and barriers to an improved quality of life?

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.

Eligibility criteria: Inclusion Criteria:

* Be at least 18 years old (by verbal history from the participant)
* 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:

* Be younger than 18 years old
* 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

Primary outcomes:
measure: Quality of Life Score (generic)
timeFrame: At 12-month after recruitment
measure: Quality of Life Score (ulcer-specific)
timeFrame: At 12-month after recruitment
Secondary outcomes:
Other outcomes:
Locations:
city: Somerville
country: United States
facility: Podimetrics,Inc.
state: Massachusetts
Study officials:
References: