Diabetic Foot UlcerNCT04769115
A Predictive Technology for Prevention of Diabetic Foot Ulcers
A study testing Alert for temperature delta in people with Diabetic Foot Ulcer, run by DAPS Health LLC at 1 site in United States.
Trial summary
The DAPSHealth system employs a predictive technology for prevention of diabetic foot ulcers, and in Real Time, identifies diabetic patients who experience lower extremity trauma and vascular obstruction utilizing the science of temperature trending. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Alert for temperature delta
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2021to 1 Jul 2021
- Phase
- Interventional
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of diabetes
- ambulatory
- smart device
Who cannot join
- non-ambulatory
- no smart device
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Predictive Technology for Prevention of Diabetic Foot Ulcers, and in Real Time, Identifying Diabetic Patients Who Experience Lower Extremity Trauma and Vascular Obstruction Utilizing the Science of Temperature (Inflammation) Trending
The DAPSHealth system employs a predictive technology for prevention of diabetic foot ulcers, and in Real Time, identifies diabetic patients who experience lower extremity trauma and vascular obstruction utilizing the science of temperature trending.
Read the detailed description
Diabetes has become a major health issue in the United States and globally, particularly among older populations. There are currently 400 million diabetics worldwide, with 30 million diagnosed diabetics living in the US.
The standard of care today in treating complications of diabetes is a reactive one: doctors often wait for a problem to occur and then treat it. This waiting approach results in high medical expenses and an increase in pain for patients.
This study is testing a predictive technology system (investigational bluetooth-enabled thermometer and mobile app) to see if it can identify potential foot complications before the damage becomes irreversible. The thermometer being used in this study is the Exergen DermaTemp (DT) Thermometer. Participants will check the temperature of each foot daily for a period of three months. These results will sync directly from the thermometer to the mobile app.
Patients are notified when temperature levels indicate a potential complication that may lead to a developing foot ulcer. The study doctor is available to determine if any trauma or vascular obstruction has occurred and will follow up with the participant.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Alert for temperature delta
- Keywords
- DFU
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alert for temperature deltaDevice
If alert for potential complications refer to appropriate specialist
| Study group | Role | What they receive |
|---|---|---|
| Response to Alerts | Other | Monitor patients daily for response to temperature changes and provide referral to doctor as needed Receives: Device: Alert for temperature delta |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predicting diabetic foot complications
Monitor patients daily for inflammatory responses to trauma to avoid complications.
This examines multiple plantar points on each foot and does a contralateral comparison to ensure there is no inflammatory response equal or greater than 4 degrees F between each pair. When this occurs over multiple days, we alert the patient to contact their physician. The temperature readings will be recorded using the DAPS Health system comprised of the Exergen DermaTemp 2000 FootScanner, DAPS Health Application and backend analysis.
Measured: Evaluate results daily and compare previous results to analyze multiple days with a contralateral delta of 4 degrees or more. This will be a running comparison over the three months of the trial.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start24 Feb 2021
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Diabetics who have no history of lower extremity (LEX) complications Diabetics who a history of LEX complications
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- DAPS Health LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Sussman, Dr., Principal investigator, DAPS Health LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04769115
- Sponsor's protocol ID
- 20204536
- Status last verified
- Aug 2021
- First submitted
- 18 Feb 2021
- Last updated
- 6 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All temperature data analysis (Alerts and disposition) based on patient history
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Predictive Technology for Prevention of Diabetic Foot Ulcers, and in Real Time, Identifying Diabetic Patients Who Experience Lower Extremity Trauma and Vascular Obstruction Utilizing the Science of Temperature (Inflammation) Trending
- ClinicalTrials.gov ID
- NCT04769115
- Acronym / sponsor ID
- 20204536
- Conditions
- Diabetic Foot Ulcer
- Keywords
- DFU
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- DAPS Health LLCUniversity, hospital or other
- Study start
- 24 Feb 2021 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 24 Feb 2021 (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 DAPSHealth system employs a predictive technology for prevention of diabetic foot ulcers, and in Real Time, identifies diabetic patients who experience lower extremity trauma and vascular obstruction utilizing the science of temperature trending.
Detailed description
Diabetes has become a major health issue in the United States and globally, particularly among older populations. There are currently 400 million diabetics worldwide, with 30 million diagnosed diabetics living in the US.
The standard of care today in treating complications of diabetes is a reactive one: doctors often wait for a problem to occur and then treat it. This waiting approach results in high medical expenses and an increase in pain for patients.
This study is testing a predictive technology system (investigational bluetooth-enabled thermometer and mobile app) to see if it can identify potential foot complications before the damage becomes irreversible. The thermometer being used in this study is the Exergen DermaTemp (DT) Thermometer. Participants will check the temperature of each foot daily for a period of three months. These results will sync directly from the thermometer to the mobile app.
Patients are notified when temperature levels indicate a potential complication that may lead to a developing foot ulcer. The study doctor is available to determine if any trauma or vascular obstruction has occurred and will follow up with the participant.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Diabetics who have no history of lower extremity (LEX) complications Diabetics who a history of LEX complications
| Arm | Type | Receives |
|---|---|---|
| Response to Alerts | Other | Device: Alert for temperature deltaMonitor patients daily for response to temperature changes and provide referral to doctor as needed |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosis of diabetes
- ambulatory
- smart device
Key exclusion criteria (2 listed)
- non-ambulatory
- no smart device
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 |
|---|---|---|
| Alert for temperature deltaIf alert for potential complications refer to appropriate specialist | Device | Response to Alerts |
Primary outcome
Predicting diabetic foot complications
Time frame: Evaluate results daily and compare previous results to analyze multiple days with a contralateral delta of 4 degrees or more. This will be a running comparison over the three months of the trial.
Monitor patients daily for inflammatory responses to trauma to avoid complications. This examines multiple plantar points on each foot and does a contralateral comparison to ensure there is no inflammatory response equal or greater than 4 degrees F between each pair. When this occurs over multiple days, we alert the patient to contact their physician. The temperature readings will be recorded using the DAPS Health system comprised of the Exergen DermaTemp 2000 FootScanner, DAPS Health Application and backend analysis.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2021.
- Individual participant dataSharing planned: Yes. All temperature data analysis (Alerts and disposition) based on patient history
Related trials for Diabetic Foot Ulcer
Recruiting
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Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
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Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
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.
Mark Sussman, Dr. principal investigator
DAPS Health LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alert for temperature delta in people with Diabetic Foot Ulcer, run by DAPS Health LLC 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 6 Aug 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predicting diabetic foot complications (time frame: Evaluate results daily and compare previous results to analyze multiple days with a contralateral delta of 4 degrees or more. This will be a running comparison over the three months of the trial.). 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 6 Aug 2021.