Patient Empowerment Study

Quality of Life Clinical Trial

Official title:

Patient Empowerment Study: Assessment of Quality of Life Among Patients With Diabetes Foot Ulcer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04537676
• Other study ID #: PCRT-0068
• Status: Not yet recruiting
• Start date: September 15, 2020
• Est. completion date: March 1, 2022

Study information

• Verified date: August 2020
• Source: Podimetrics, Inc.
• Contact: Brian J Petersen
• Phone: 8605589240
• Email: brian[@]podimetrics.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: March 1, 2022
• Est. primary completion date: October 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Complications
• Diabetic Foot
• Mental Health Wellness 1
• Quality of Life
• Ulcer
• Ulcer Foot

Intervention

Other:
• No intervention, this is an observational study
No intervention

Locations

Country	Name	City	State
United States	Podimetrics,Inc.	Somerville	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Podimetrics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life Score (generic)	Quality of Life will be measured by the Medical Outcomes Study 36-item Short-Form Questionnaire (SF-36). This questionnaire addresses general quality of life issues.	At 12-month after recruitment
Primary	Quality of Life Score (ulcer-specific)	Quality of Life will also be measured by theDiabetic Foot Ulcer Scale Short Form (DFS-SF). This questionnaire addresses issues specific to diabetic foot diseases, such as ulcer severity and impact of ulcer care.	At 12-month after recruitment