Foot Ulcer, DiabeticNCT02647346
In-Home Assessment of a Smart Foot Mat for Prevention of Diabetic Foot Ulcers
A study testing Daily use of podimetrics smart-foot mat in people with Foot Ulcer, Diabetic, run by Podimetrics, Inc. at 8 sites in United States.
Trial summary
The purpose of this study is to investigate the accuracy of a Smart Foot Mat for signals associated with diabetic foot ulcers in high-risk patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Foot Ulcer, Diabetic
- What is being tested?
- Daily use of podimetrics smart-foot mat
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 8 sitesUnited States
- Study dates
- Nov 2013to Feb 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Male/Female, 18 years or older
- Diagnosis of type 1 or type 2 Diabetes Mellitus, controlled or uncontrolled
- Ankle Brachial Index (ABI) >0.5
- Patient with history of previous foot ulcer.
Who cannot join
- Active Charcot foot disease
- One or more plantar foot ulcers (UT Grade 1A-C, 2A-C \& 3A-C)
- Active Infection/Gangrene
- Active malignancy
- Immunosuppressive disease
- History of alcohol or drug abuse
Show all 12Show fewer
- Pregnant women (verbal confirmation or confirmation obtained within current medical records)
- Cognitive deficit
- 2+ or great lower extremity edema
- End stage renal disease
- History of major lower extremity amputation (below knee or above knee amputation)
- Other issue that, at the discretion of the investigator, renders the subject ineligible for participation.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Center for Clinical Research Castro Valley
Castro Valley, California, 94546
MetroWest Medical Center
Framingham, Massachusetts, 01702
Limb Preservation Platform
Fresno, California, 93721
Greenville Health System
Greenville, South Carolina, 29615
VA Long Beach Health System
Long Beach, California, 90822
Miami VA Healthcare System
Miami, Florida, 33125
Phoenix VA Health Care System
Phoenix, Arizona, 85012
University of Arizona
Tucson, Arizona, 85724
About this study
The purpose of this study is to investigate the accuracy of a Smart Foot Mat for signals associated with diabetic foot ulcers in high-risk patients.
- Conditions
- Foot Ulcer, Diabetic
- Being tested
- Daily use of podimetrics smart-foot mat
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily use of podimetrics smart-foot matDevice
| Study group | Role | What they receive |
|---|---|---|
| Participant cohort | Experimental | Participants with diabetes that each have a history of healed Diabetic Foot Ulcer (DFU) prior to enrollment. Receives: Device: Daily use of podimetrics smart-foot mat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Plantar Diabetic Foot Ulcer
Measured: Through study completion or subject withdrawal (34 weeks per-protocol)
Secondary outcomes (3)
Subject Adherence in Daily Use of the Study Device
Measured: Through study completion or subject withdrawal (34 weeks per-protocol)
Device-related Trips/Falls
Measured: Through study completion or subject withdrawal (34 weeks per-protocol)
Device-related Injuries
Measured: Through study completion or subject withdrawal (34 weeks per-protocol)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2016 (estimated)
- Study startNov 2013
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Foot Ulcer, DiabeticStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Podimetrics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02647346
- Sponsor's protocol ID
- P-04
- Status last verified
- Feb 2020
- First submitted
- 4 Jan 2016
- Last updated
- 21 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Petersen BJ, Rothenberg GM, Lakhani PJ, Zhou M, Linders DR, Bloom JD, Wood KA, Armstrong DG. Ulcer metastasis? Anatomical locations of recurrence for patients in diabetic foot remission. J Foot Ankle Res. 2020 Jan 13;13:1. doi: 10.1186/s13047-020-0369-3. eCollection 2020.
PubMed 31956341Frykberg RG, Gordon IL, Reyzelman AM, Cazzell SM, Fitzgerald RH, Rothenberg GM, Bloom JD, Petersen BJ, Linders DR, Nouvong A, Najafi B. Feasibility and Efficacy of a Smart Mat Technology to Predict Development of Diabetic Plantar Ulcers. Diabetes Care. 2017 Jul;40(7):973-980. doi: 10.2337/dc16-2294. Epub 2017 May 2.
PubMed 28465454
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-Home Assessment of a Smart Foot Mat for Prevention of Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT02647346
- Acronym / sponsor ID
- P-04
- Conditions
- Foot Ulcer, Diabetic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Podimetrics, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 6 Jan 2016 (estimated)
- Results
- Posted 5 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the accuracy of a Smart Foot Mat for signals associated with diabetic foot ulcers in high-risk patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participant cohort | Experimental | Device: Daily use of podimetrics smart-foot matParticipants with diabetes that each have a history of healed Diabetic Foot Ulcer (DFU) prior to enrollment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male/Female, 18 years or older
- Diagnosis of type 1 or type 2 Diabetes Mellitus, controlled or uncontrolled
- Ankle Brachial Index (ABI) >0.5
- Patient with history of previous foot ulcer.
Key exclusion criteria (12 listed)
- Active Charcot foot disease
- One or more plantar foot ulcers (UT Grade 1A-C, 2A-C \& 3A-C)
- Active Infection/Gangrene
- Active malignancy
- Immunosuppressive disease
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 |
|---|---|---|
| Daily use of podimetrics smart-foot mat | Device | Participant cohort |
Primary outcome
Occurrence of Plantar Diabetic Foot Ulcer
Time frame: Through study completion or subject withdrawal (34 weeks per-protocol)
3 secondary outcomes
Subject Adherence in Daily Use of the Study Device
Time frame: Through study completion or subject withdrawal (34 weeks per-protocol)
Device-related Trips/Falls
Time frame: Through study completion or subject withdrawal (34 weeks per-protocol)
Device-related Injuries
Time frame: Through study completion or subject withdrawal (34 weeks per-protocol)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31956341Petersen BJ, Rothenberg GM, Lakhani PJ, Zhou M, Linders DR, Bloom JD, Wood KA, Armstrong DG. Ulcer metastasis? Anatomical locations of recurrence for patients in diabetic foot remission. J Foot Ankle Res. 2020 Jan 13;13:1. doi: 10.1186/s13047-020-0369-3. eCollection 2020.
- Derived from this study: PubMed 28465454Frykberg RG, Gordon IL, Reyzelman AM, Cazzell SM, Fitzgerald RH, Rothenberg GM, Bloom JD, Petersen BJ, Linders DR, Nouvong A, Najafi B. Feasibility and Efficacy of a Smart Mat Technology to Predict Development of Diabetic Plantar Ulcers. Diabetes Care. 2017 Jul;40(7):973-980. doi: 10.2337/dc16-2294. Epub 2017 May 2.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily use of podimetrics smart-foot mat in people with Foot Ulcer, Diabetic, run by Podimetrics, Inc. at 8 sites 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 4 inclusion and 12 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 21 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
Yes. Results are posted in the registry (first posted 5 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Occurrence of Plantar Diabetic Foot Ulcer (time frame: Through study completion or subject withdrawal (34 weeks per-protocol)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02647346, which also lists 2 linked publications.
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 21 Feb 2020.