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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04537676
Other study ID # PCRT-0068
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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