Diabetic FootNCT02373592
Implementation of Foot Thermometry and SMS and Voice Messaging to Prevent Diabetic Foot Ulcer
A study testing SMS and voice messaging and Thermometry in people with Diabetic Foot, run by Universidad Peruana Cayetano Heredia at 2 sites in Peru.
Trial summary
This study aims to implement daily temperature measurements of feet complemented by SMS and voice messaging to prevent diabetic foot ulcers in patients with type 2 diabetes mellitus at high risk of ulceration. Design: Physician-blinded, randomized, 18-month trial. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Foot
- What is being tested?
- SMS and voice messaging and Thermometry
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 172 participants
- Where
- 2 sitesPeru
- Study dates
- Sep 2015to Oct 2017
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of type 2 diabetes mellitus.
- Dorsalis pedis pulse in both feet.
- In risk group 2 or 3 using the diabetic foot risk classification system as specified by the International Working Group on the Diabetic Foot.
- Operating cell phone or a caregiver with an operating cell phone.
- Ability to provide informed consent.
Who cannot join
- Current ulcers or open amputation sites.
- Active osteoarthropathy
- Severe peripheral vascular disease
- Foot infection
Trial locations and contacts
2 sites in 1 country.
Peru2 sites
Hospital Cayetano Heredia
Lima, Lima 31
Hospital Nacional Arzobispo Loayza
Lima, Lima 5
About this study
This study aims to implement daily temperature measurements of feet complemented by SMS and voice messaging to prevent diabetic foot ulcers in patients with type 2 diabetes mellitus at high risk of ulceration.
Design: Physician-blinded, randomized, 18-month trial.
Read more
Setting: Diabetes outpatient clinics from two public hospitals
Population: Subjects will be eligible if they (1) have a diagnosis of type 2 diabetes mellitus, (2) are between 18 - 80 years of age, (3) have a present dorsalis pedis pulse in both feet, (4) are in risk group 2 or 3 using the diabetic foot risk classification system as specified by the International Working Group on the Diabetic Foot, (5) have an operating cell phone or a caregiver with an operating cell phone, and (6) have the ability to provide informed consent.
Hypothesis: The investigators hypothesize that implementation of an enhanced intervention that combines daily temperature measurement for the reduction of diabetic foot ulcer with SMS and voice messaging will improve patient measurement compliance and reduce diabetic foot ulcers in a middle income country.
Read the detailed description
Detailed Description:
Thermometry is a promising emerging modality for the prevention of diabetic foot ulcers according to different clinical trials. However, patient compliance with self-monitoring temperature at home is a concern, as they may be forgetful or find it difficult to get into a consistent routine of daily monitoring. Therefore, the investigators propose to determine the utility of SMS and voice messaging to remind the patients to perform the thermometry, and to assess the impact on diabetic foot ulceration.
Specific Aims are:
- Compare the incidence of diabetic foot ulceration during the study between the arm that receives thermometry alone and the arm that receives thermometry plus SMS and voice messaging.
- Compare the compliance with foot thermometer use between the two study arms.
- Compare the frequency of alarms signs reported to the study nurse in the two study arms.
- Compare the frequency of alarms signs reported in the patient's logbooks in the two study arms.
- Compare the incidence of diabetic foot ulceration according to pre-specified sub-groups: caregiving status, and use of insoles and/or orthopedic shoes.
- In the intervention-only group, compare the incidence of diabetic foot ulcers by varying the recipient of the messaging intervention (patient vs caregivers).
Intervention:
- Placebo Comparator: Thermometry-only group. Subjects will be provided with a TempStat (foot thermometer), a device that captures a thermal image of feet through colors. Some alarm signs have been pre-specified: 1) When the thermal image shows yellow spots in any area of any feet for two consecutive days, 2) when the thermal image shows different colors in contralateral areas of the feet for two consecutive days or, 3) a dermal lesion is detected at any time. In any of these three scenarios, subjects will be instructed to contact the study nurse by phone or text message. For the first two types of alarm signs, once the study nurse is contacted he/ she will ask about the presence of lesions in the patient's feet and the patient's activity on the previous two weeks, and will provide recommendations on how to decrease activity until temperatures normalize. If TempStat measurements continue to show alarm signs for more than one week after the telephone consultation, the participant will be asked to contact the nurse and schedule a face-to-face evaluation to assess the presence of an infection and/or ulcer with a masked assessor. In the third type of alarm sign, presence of a dermal lesion, participants will be asked to contact the study's nurse and he/she will make an appointment for an evaluation with a nurse blind to the intervention. When the main outcome, foot ulceration, has been confirmed, patients will be directed by the study nurse to receive professional care by a specialist.
- Experimental: Thermometry plus SMS and voice messaging Thermometry-related intervention activities will be the same as those established for the thermometry-only group. In addition, this group will receive reminders to use the TempStat (two messages) and promote foot care (six messages). The content of these eight messages has been developed and validated through both via SMS and voice messaging. During the first two weeks of the intervention, only reminders to use the TempStat will be sent, daily, Monday to Friday, both SMS and voice messaging. Hereafter, for the remaining 76 weeks, patients will only receive two messages per week, one SMS and one voice message, alternating content (reminders to use TempStat and promotion of foot care).
- Conditions
- Diabetic Foot
- Being tested
- SMS and voice messaging, Thermometry
- Keywords
- Diabetic Neuropathies, Thermometry, Diabetes Mellitus, Type 2, Foot Ulcer, Telemedicine
- Medical subject headings
- Diabetic Foot, Diabetic Neuropathies, Diabetes Mellitus, Type 2, Foot Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMS and voice messagingBehavioural
This group will receive reminders to use the TempStat (two messages) and promote foot care (six messages). The content of these eight messages have been developed and validated their delivery through both, SMS and voice messaging.
During the first two weeks of the intervention, only reminders to use the TempStat will be sent, daily, Monday to Friday, both via SMS and voice messaging.
Hereafter, for the remaining 76 weeks, patients will only receive two messages per week, one SMS and one voice message, alternating content (reminders to use TempStat and promotion of foot care).
ThermometryDevice
Subjects will be provided with a TempStat (foot thermometer), a device that captures a thermal image of feet. (See Detailed description)
| Study group | Role | What they receive |
|---|---|---|
| Thermometry-only group | Placebo comparator | Subjects will be provided with a TempStat (foot thermometer), a device that captures a thermal image of feet.
Some alarm signs have been pre-specified: 1) thermal image shows yellow spots in any area of feet for two consecutive days, 2) thermal image shows different colors in contralateral areas of the feet for two consecutive days or, 3) a dermal lesion. In any of these three scenarios, subjects will be instructed to contact the study nurse by phone. (See Detailed Description for more detail on the actions after an alarm sign has been observed) Receives: Device: Thermometry |
| Thermometry plus SMS and voice messaging | Experimental | Thermometry-related intervention activities will be the same as those established for the thermometry-only group. In addition, this group will receive reminders to use the TempStat (two messages) and promote foot care (six messages). The content of these eight messages has been developed and validated through both SMS and voice messaging.
During the first two weeks of the intervention, only reminders to use the TempStat will be sent, daily, Monday to Friday, both via SMS and voice messaging.
Hereafter, for the remaining 76 weeks, patients will only receive two messages per week, one SMS and one voice message, alternating content (reminders to use TempStat and promotion of foot care). Receives: Behavioral: SMS and voice messaging; Device: Thermometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foot ulceration
The primary outcome is foot ulceration occurring at any point during the 12 month study duration.
Foot ulceration will be defined using the American Diabetes Association criteria, which defines ulcers as any break in the cutaneous barrier; that usually extend through the full thickness of the dermis. There will be two ways of identifying if a patient has developed foot ulceration: (1) during the clinical evaluations done by a nurse every 2 months. (2) In addition to these bimonthly assessments, patients will be advised to make telephone calls to the study's nurse to report the presence of an ulcer, and he/she will be asked to go to the hospital for a face-to-face evaluation to be conducted by a masked nurse.
Measured: 18 months
Secondary outcomes (5)
Adherence to daily temperature measurement
Adherence to temperature measurements will be based on patient self-report of foot temperature monitoring through recording in patient's logbooks.
Measured: 18 months
Report of an alarm sign to the nurse
Compare the frequency of alarms signs reported to the study nurse
Measured: 18 months
Report of an alarm sign in the logbook
Compare the frequency of alarms signs reported in the patient's logbooks.
Measured: 18 months
Dose-response analysis of SMS and voice messaging
Dose-response per protocol analysis will be performed.
Measured: 18 months
Glycosilated hemoglobin control targets
Reduce of 1% or more of glycosylated hemoglobin.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2015 (estimated)
- Study startSep 2015
- Primary completionSep 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Peruana Cayetano Heredia
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University, Mayo Clinic, University of Southern California
- Responsible party
- Principal investigator, Jaime Miranda, Universidad Peruana Cayetano Heredia
- Investigators
- Jaime Miranda, MD, PhD, Principal investigator, Universidad Peruana Cayetano Heredia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02373592
- Sponsor's protocol ID
- 1R21TW009982
- Status last verified
- Aug 2017
- First submitted
- 20 Feb 2015
- Last updated
- 15 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Lazo-Porras M, Bernabe-Ortiz A, Sacksteder KA, Gilman RH, Malaga G, Armstrong DG, Miranda JJ. Implementation of foot thermometry plus mHealth to prevent diabetic foot ulcers: study protocol for a randomized controlled trial. Trials. 2016 Apr 19;17(1):206. doi: 10.1186/s13063-016-1333-1.
PubMed 27094007Lazo-Porras M, Bernabe-Ortiz A, Taype-Rondan A, Gilman RH, Malaga G, Manrique H, Neyra L, Calderon J, Pinto M, Armstrong DG, Montori VM, Miranda JJ. Foot thermometry with mHeath-based supplementation to prevent diabetic foot ulcers: A randomized controlled trial. Wellcome Open Res. 2020 Aug 28;5:23. doi: 10.12688/wellcomeopenres.15531.2. eCollection 2020.
PubMed 32923686
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Foot Thermometry and SMS and Voice Messaging to Prevent Diabetic Foot Ulcer
- ClinicalTrials.gov ID
- NCT02373592
- Acronym / sponsor ID
- 1R21TW009982
- Conditions
- Diabetic Foot
- Keywords
- Diabetic Neuropathies, Thermometry, Diabetes Mellitus, Type 2, Foot Ulcer, Telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Universidad Peruana Cayetano HerediaUniversity, hospital or other
- Collaborators
- Johns Hopkins University, Mayo Clinic, University of Southern California
- Study start
- Sep 2015 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 27 Feb 2015 (estimated)
- 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.
This study aims to implement daily temperature measurements of feet complemented by SMS and voice messaging to prevent diabetic foot ulcers in patients with type 2 diabetes mellitus at high risk of ulceration.
Design: Physician-blinded, randomized, 18-month trial.
Setting: Diabetes outpatient clinics from two public hospitals
Population: Subjects will be eligible if they (1) have a diagnosis of type 2 diabetes mellitus, (2) are between 18 - 80 years of age, (3) have a present dorsalis pedis pulse in both feet, (4) are in risk group 2 or 3 using the diabetic foot risk classification system as specified by the International Working Group on the Diabetic Foot, (5) have an operating cell phone or a caregiver with an operating cell phone, and (6) have the ability to provide informed consent.
Hypothesis: The investigators hypothesize that implementation of an enhanced intervention that combines daily temperature measurement for the reduction of diabetic foot ulcer with SMS and voice messaging will improve patient measurement compliance and reduce diabetic foot ulcers in a middle income country.
Detailed description
Detailed Description:
Thermometry is a promising emerging modality for the prevention of diabetic foot ulcers according to different clinical trials. However, patient compliance with self-monitoring temperature at home is a concern, as they may be forgetful or find it difficult to get into a consistent routine of daily monitoring. Therefore, the investigators propose to determine the utility of SMS and voice messaging to remind the patients to perform the thermometry, and to assess the impact on diabetic foot ulceration.
Specific Aims are:
- Compare the incidence of diabetic foot ulceration during the study between the arm that receives thermometry alone and the arm that receives thermometry plus SMS and voice messaging.
- Compare the compliance with foot thermometer use between the two study arms.
- Compare the frequency of alarms signs reported to the study nurse in the two study arms.
- Compare the frequency of alarms signs reported in the patient's logbooks in the two study arms.
- Compare the incidence of diabetic foot ulceration according to pre-specified sub-groups: caregiving status, and use of insoles and/or orthopedic shoes.
- In the intervention-only group, compare the incidence of diabetic foot ulcers by varying the recipient of the messaging intervention (patient vs caregivers).
Intervention:
- Placebo Comparator: Thermometry-only group. Subjects will be provided with a TempStat (foot thermometer), a device that captures a thermal image of feet through colors. Some alarm signs have been pre-specified: 1) When the thermal image shows yellow spots in any area of any feet for two consecutive days, 2) when the thermal image shows different colors in contralateral areas of the feet for two consecutive days or, 3) a dermal lesion is detected at any time. In any of these three scenarios, subjects will be instructed to contact the study nurse by phone or text message. For the first two types of alarm signs, once the study nurse is contacted he/ she will ask about the presence of lesions in the patient's feet and the patient's activity on the previous two weeks, and will provide recommendations on how to decrease activity until temperatures normalize. If TempStat measurements continue to show alarm signs for more than one week after the telephone consultation, the participant will be asked to contact the nurse and schedule a face-to-face evaluation to assess the presence of an infection and/or ulcer with a masked assessor. In the third type of alarm sign, presence of a dermal lesion, participants will be asked to contact the study's nurse and he/she will make an appointment for an evaluation with a nurse blind to the intervention. When the main outcome, foot ulceration, has been confirmed, patients will be directed by the study nurse to receive professional care by a specialist.
- Experimental: Thermometry plus SMS and voice messaging Thermometry-related intervention activities will be the same as those established for the thermometry-only group. In addition, this group will receive reminders to use the TempStat (two messages) and promote foot care (six messages). The content of these eight messages has been developed and validated through both via SMS and voice messaging. During the first two weeks of the intervention, only reminders to use the TempStat will be sent, daily, Monday to Friday, both SMS and voice messaging. Hereafter, for the remaining 76 weeks, patients will only receive two messages per week, one SMS and one voice message, alternating content (reminders to use TempStat and promotion of foot care).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thermometry-only group | Placebo comparator | Device: ThermometrySubjects will be provided with a TempStat (foot thermometer), a device that captures a thermal image of feet. Some alarm signs have been pre-specified: 1) thermal image shows yellow spots in any area of feet for two consecutive days, 2) thermal image shows different colors in contralateral areas of the feet for two consecutive days or, 3) a dermal lesion. In any of these three scenarios, subjects will be instructed to contact the study nurse by phone. (See Detailed Description for more detail on the actions after an alarm sign has been observed) |
| Thermometry plus SMS and voice messaging | Experimental | Behavioral: SMS and voice messaging, Device: ThermometryThermometry-related intervention activities will be the same as those established for the thermometry-only group. In addition, this group will receive reminders to use the TempStat (two messages) and promote foot care (six messages). The content of these eight messages has been developed and validated through both SMS and voice messaging. During the first two weeks of the intervention, only reminders to use the TempStat will be sent, daily, Monday to Friday, both via SMS and voice messaging. Hereafter, for the remaining 76 weeks, patients will only receive two messages per week, one SMS and one voice message, alternating content (reminders to use TempStat and promotion of foot care). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of type 2 diabetes mellitus.
- Dorsalis pedis pulse in both feet.
- In risk group 2 or 3 using the diabetic foot risk classification system as specified by the International Working Group on the Diabetic Foot.
- Operating cell phone or a caregiver with an operating cell phone.
- Ability to provide informed consent.
Key exclusion criteria (4 listed)
- Current ulcers or open amputation sites.
- Active osteoarthropathy
- Severe peripheral vascular disease
- Foot infection
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 |
|---|---|---|
| SMS and voice messagingThis group will receive reminders to use the TempStat (two messages) and promote foot care (six messages). The content of these eight messages have been developed and validated their delivery through both, SMS and voice messaging. During the first two weeks of the intervention, only reminders to use the TempStat will be sent, daily, Monday to Friday, both via SMS and voice messaging. Hereafter, for the remaining 76 weeks, patients will only receive two messages per week, one SMS and one voice message, alternating content (reminders to use TempStat and promotion of foot care). | Behavioural | Thermometry plus SMS and voice messaging |
| ThermometrySubjects will be provided with a TempStat (foot thermometer), a device that captures a thermal image of feet. (See Detailed description) | Device | Thermometry plus SMS and voice messaging, Thermometry-only group |
Primary outcome
Foot ulceration
Time frame: 18 months
The primary outcome is foot ulceration occurring at any point during the 12 month study duration. Foot ulceration will be defined using the American Diabetes Association criteria, which defines ulcers as any break in the cutaneous barrier; that usually extend through the full thickness of the dermis. There will be two ways of identifying if a patient has developed foot ulceration: (1) during the clinical evaluations done by a nurse every 2 months. (2) In addition to these bimonthly assessments, patients will be advised to make telephone calls to the study's nurse to report the presence of an ulcer, and he/she will be asked to go to the hospital for a face-to-face evaluation to be conducted by a masked nurse.
5 secondary outcomes
Adherence to daily temperature measurement
Time frame: 18 months
Report of an alarm sign to the nurse
Time frame: 18 months
Report of an alarm sign in the logbook
Time frame: 18 months
Dose-response analysis of SMS and voice messaging
Time frame: 18 months
Glycosilated hemoglobin control targets
Time frame: 18 months
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 15 Dec 2017.
- Background: PubMed 27094007Lazo-Porras M, Bernabe-Ortiz A, Sacksteder KA, Gilman RH, Malaga G, Armstrong DG, Miranda JJ. Implementation of foot thermometry plus mHealth to prevent diabetic foot ulcers: study protocol for a randomized controlled trial. Trials. 2016 Apr 19;17(1):206. doi: 10.1186/s13063-016-1333-1.
- Derived from this study: PubMed 32923686Lazo-Porras M, Bernabe-Ortiz A, Taype-Rondan A, Gilman RH, Malaga G, Manrique H, Neyra L, Calderon J, Pinto M, Armstrong DG, Montori VM, Miranda JJ. Foot thermometry with mHeath-based supplementation to prevent diabetic foot ulcers: A randomized controlled trial. Wellcome Open Res. 2020 Aug 28;5:23. doi: 10.12688/wellcomeopenres.15531.2. eCollection 2020.
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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.
Jaime Miranda, MD, PhD principal investigator
Universidad Peruana Cayetano Heredia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMS and voice messaging and Thermometry in people with Diabetic Foot, run by Universidad Peruana Cayetano Heredia at 2 sites in Peru.
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 5 inclusion and 4 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 15 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Peru. 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. Some participants in this study may receive a placebo. 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?
Foot ulceration (time frame: 18 months). 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 NCT02373592, 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 15 Dec 2017.