Patient Empowerment Study

Status unconfirmed

Conditions studied: Diabetic Foot, Quality of Life, Mental Health Wellness 1, Ulcer Foot, Diabetes Complications

In brief

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.

Key facts

Study ID

NCT04537676

Run by

Podimetrics, Inc.

People needed

200

Starts

2020-09-15

Expected to finish

2022-03-01

Last updated by the study team

2020-09-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Podimetrics,Inc. — Somerville, Massachusetts, United States

Full record on ClinicalTrials.gov

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