Diabetic FootNCT04537676
Patient Empowerment Study
An observational study of Diabetic Foot and Quality of Life, run by Podimetrics, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot, Quality of Life, Mental Health Wellness 1
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2020to 1 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Abbie Liu contact
About this study
Official title: Patient Empowerment Study: Assessment of Quality of Life Among Patients With Diabetes Foot Ulcer
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.
Read the 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.
- Conditions
- Diabetic Foot, Quality of Life, Mental Health Wellness 1, Ulcer Foot, Diabetes Complications
- Being tested
- No intervention, this is an observational study
- Keywords
- Diabetic Foot, Quality of Life, Foot Ulcer
- Medical subject headings
- Diabetic Foot, Foot Ulcer, Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention, this is an observational studyOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No intervention, this is an observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At 12-month after recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2020
- Study start15 Sep 2020 (estimated)
- Primary completion15 Oct 2021 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Podimetrics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04537676
- Sponsor's protocol ID
- PCRT-0068
- Status last verified
- Aug 2020
- First submitted
- 28 Aug 2020
- Last updated
- 3 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Empowerment Study: Assessment of Quality of Life Among Patients With Diabetes Foot Ulcer
- ClinicalTrials.gov ID
- NCT04537676
- Acronym / sponsor ID
- PCRT-0068
- Conditions
- Diabetic Foot, Quality of Life, Mental Health Wellness 1, Ulcer Foot, Diabetes Complications
- Keywords
- Diabetic Foot, Quality of Life, Foot Ulcer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Podimetrics, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Sep 2020 (estimated)
- Primary completion
- 15 Oct 2021 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 3 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DFU Participants | – | Other: No intervention, this is an observational studyA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention, this is an observational studyNo intervention | Other | DFU Participants |
Primary outcome
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
- Individual participant dataSharing planned: No. 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.
Related trials for Diabetic Foot
RecruitingPhase 2
Evaluation of the Safety and Efficacy of Live ASCs in the Treatment of Diabetic Foot Syndrome.
Diabetic Foot Ulcer
RecruitingObservational study
Efficacy and Safety of a Nitric Oxide Generating Dressing for Diabetic Foot Ulcers (ONWARD)
Diabetic Foot Ulcers (DFUs)
Not yet recruitingPhase 1
Placental Cells for Diabetic Foot Ulcers
Diabetic Foot Ulcer
RecruitingObservational study
Factors Associated With an Evolution in the Quality of Life of Diabetic Patients With Chronic, Wound-free Charcot Foot
Charcot Joint of Foot, Osteoarthropathy
Not yet recruiting
Subcutaneous Dexpanthenol Administration and Wound Epithelialization
Chronic Wounds, Diabetic Foot Ulcer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abbie Liu contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Foot and Quality of Life, run by Podimetrics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brian J Petersen (8605589240, brian@podimetrics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life Score (generic) (time frame: At 12-month after recruitment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2020.