Patient Empowerment Study
1 other identifier
observational
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 28, 2020
CompletedFirst Posted
Study publicly available on registry
September 3, 2020
CompletedStudy Start
First participant enrolled
September 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2022
CompletedSeptember 3, 2020
August 1, 2020
1.1 years
August 28, 2020
September 2, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
Study Arms (1)
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.
Interventions
Eligibility Criteria
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.
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Podimetrics,Inc.
Somerville, Massachusetts, 02144, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2020
First Posted
September 3, 2020
Study Start
September 15, 2020
Primary Completion
October 15, 2021
Study Completion
March 1, 2022
Last Updated
September 3, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share
To protect participant identity, names will not be recorded as part of this study. Instead, each participant will be assigned a unique identifier. Any identifiable data will not be associated with the information collected by the questionnaires.