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Patient Empowerment Study

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ClinicalTrials.gov Identifier: NCT04537676
Recruitment Status : Not yet recruiting
First Posted : September 3, 2020
Last Update Posted : September 3, 2020
Sponsor:
Information provided by (Responsible Party):
Podimetrics, Inc.

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Diabetic Foot Quality of Life Mental Health Wellness 1 Ulcer Foot Diabetes Complications Other: No intervention, this is an observational study

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Patient Empowerment Study: Assessment of Quality of Life Among Patients With Diabetes Foot Ulcer
Estimated Study Start Date : September 15, 2020
Estimated Primary Completion Date : October 15, 2021
Estimated Study Completion Date : March 1, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
 Other: No intervention, this is an observational study
No intervention


Outcome Measures
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Primary Outcome Measures :
  1. Quality of Life Score (generic) [ Time Frame: At 12-month after recruitment ]
    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.

  2. Quality of Life Score (ulcer-specific) [ Time Frame: At 12-month after recruitment ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04537676


Contacts
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Contact: Brian J Petersen 8605589240 brian@podimetrics.com
Contact: Abbie Liu abbie@podimetrics.com

Locations
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United States, Massachusetts
Podimetrics,Inc.
Somerville, Massachusetts, United States, 02144
Sponsors and Collaborators
Podimetrics, Inc.
More Information
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Responsible Party: Podimetrics, Inc.
ClinicalTrials.gov Identifier: NCT04537676    
Other Study ID Numbers: PCRT-0068
First Posted: September 3, 2020    Key Record Dates
Last Update Posted: September 3, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Podimetrics, Inc.:
Diabetic Foot
Quality of Life
Foot Ulcer
Additional relevant MeSH terms:
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Diabetic Foot
Diabetes Complications
Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
 Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies