DiabetesSTEP UPNCT02356848
STEP UP to Avert Amputation in Diabetes
A study testing Tailored Intervention (TI) and Current Practice (CP) in people with Diabetes and Foot Ulcer, run by VA Office of Research and Development at 1 site in United States.
Trial summary
This study will evaluate a comprehensive tailored behavioral intervention aimed to improve foot self-care and self-monitoring (combined with dermal thermometry) to prevent recurrent ulcers in Veterans at highest risk of amputation. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Diabetes, Foot Ulcer
- What is being tested?
- Tailored Intervention (TI) and Current Practice (CP)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 241 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2015to 30 Sep 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (21 years) with Type 2 diabetes
- History of healed diabetic foot ulcer (>3 months)
- Diabetes therapy for > 6 months
- An available phone and receiving continuity of care at the VA (at least 2 primary care visits in the previous 1.5 years at the recruitment site)
Who cannot join
- Patients with an active foot ulcer
- Acute cardiovascular disease (CVD) events < 3 months ago
- Poor estimated short-term survival (< 1 year)
- Recent major surgery (< 3 months)
- Prior foot amputation
- Inability to exercise
- Temporary residence in the area
- Inability to provide consent will be excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
New York, New York, 10010
About this study
This study will evaluate a comprehensive tailored behavioral intervention aimed to improve foot self-care and self-monitoring (combined with dermal thermometry) to prevent recurrent ulcers in Veterans at highest risk of amputation. This intervention may be a novel strategy for improving self-care and early detection of foot abnormalities in this at-risk population using psychological theories to target multiple health behaviors simultaneously. This could be an efficient and cost-effective approach to improve diabetes-related foot health behavior, and other risk factors in patients who are vulnerable to devastating consequences related to amputation.
Read the detailed description
Veterans with diabetes who have had a previous ulcer are at highest risk for new ulcers and amputation, particularly if they have neuropathy or vascular disease and have poor foot self-care or nonadherence to diet, medication, and exercise recommendations. It is difficult to activate at-risk patients to improve self-care and detect foot abnormalities or inflammation at an early stage.
Proposed is a randomized controlled trial testing the effectiveness of a comprehensive tailored intervention (TI) aimed to improve self-care and self-monitoring (including dermal thermometry) through behavioral counseling. The primary specific aim is to evaluate if TI reduces the proportion of recurrent ulcers at 18 months compared to the current practice (CP) group. The secondary specific aims are to evaluate the impact of TI on time to ulceration, quality of life (QOL), plantar pressure, physical activity and foot care skills compared to the CP group.
The investigators will recruit adults with diabetes who have had a previously healed ulcer. The intervention will be standardized and fidelity of the intervention will be maintained. Using a blinded randomized controlled trial (RCT), the investigators will test the effect of TI in relation to CP. Key outcomes are ulceration, quality of life (QOL), plantar pressure, physical activity and foot care skills. Outcomes will be measured at baseline, 6, 12 and 18 months. All analyses will be intent-to-treat.
This study will evaluate a comprehensive tailored intervention targeting multiple behaviors related to self-care and amputation risk. This study applies advanced behavioral theories to intervene to improve care for veterans at risk for amputation combined with dermal thermometry. If this promising theory-driven approach can work in a clinical setting where improvements in foot care are urgently needed for these vulnerable Veterans with a previous ulcer, it will be an important scientific contribution that could lower the risk of recurrent ulcers and amputation in Veterans with diabetes.
- Conditions
- Diabetes, Foot Ulcer
- Being tested
- Tailored Intervention (TI), Current Practice (CP)
- Keywords
- self-care, self-monitoring, secondary prevention, foot ulcer, Diabetic Foot Ulcer
- Medical subject headings
- Diabetes Mellitus, Foot Ulcer, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored Intervention (TI)Behavioural
Participants in this arm will receive a comprehensive intervention based on the Transtheoretical Model and Prospect Theory with the counseling being delivered by health counselors using MI principles.
Current Practice (CP)Behavioural
this group will receive calls and mailings focusing on providing education and prevention strategies for health conditions such as colorectal cancer, influenza, insomnia, vision, dementia, and oral disease.
| Study group | Role | What they receive |
|---|---|---|
| Tailored intervention (TI) | Experimental | Participants in this arm will receive a comprehensive intervention based on the Transtheoretical Model and Prospect Theory with the counseling being delivered by health counselors using MI principles. This arm will have biweekly calls for the first two months and then monthly calls for the next four months followed by texts or mailings for months 7-18 with the frequency determine by level of treatment adherence. Receives: Behavioral: Tailored Intervention (TI) |
| Current Practice (CP) | Placebo comparator | This group will receive all the enhancements that the VA has targeted to improve foot risk in diabetes including full EMR functionality, clinical reminders to improve care, and Patient-Centered Medical Home (PCMH) implementation with its benefits for diabetes care. To control for attention and preserve blinding, this group will receive calls and mailings focusing on providing education and prevention strategies for health conditions such as colorectal cancer, influenza, insomnia, vision, dementia, and oral disease. This arm will have biweekly calls for the first two months and then monthly calls for the next four months followed by texts or mailings for months 7-18 with the frequency determine by level of treatment adherence to general health recommendations Receives: Behavioral: Current Practice (CP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ulceration
High-resolution standard view digital photographs of the feet and footwear will be obtained and reviewed by the investigators blinded to group assignment, and a suspected ulcer or nonulcerative plantar lesion below the malleoli will be referred to a panel of three blinded (as to group assignment) adjudicators, all clinical experts. Lesions will be judged as absent/nonulcerative lesion/ulcer; involving/not involving the plantar surface (defined as involving the weight-bearing surface of the foot); and related to metatarsal head (MTH)/not related to MTH. Adjudicators will not confer with each other or with the study staff, and the majority opinion will be taken as the final judgment. Ulcers will be judged to be present if the integrity of both the epidermis and dermis is broken. When ulcers occur in between study visits, the adjudication committee will review the medical records and make the determination.
Measured: 18 months
Secondary outcomes (5)
Foot care skills
The investigators will use the Veterans foot self-care education and behavior survey to assess different subscales of foot care. The investigators will measure basic foot-care education, extended foot-care education, basic professional foot care, extended professional foot care, basic foot self-care, and extended foot self-care using this survey that was developed and validated in high-risk Veterans.
Measured: 18 months
General Quality of Life
The SF-36 will assess general well-being, and physical and mental health
Measured: 18 months
Foot health-specific quality of life
The Foot Health Status Questionnaire (FHSQ),93 a reliable and valid instrument, will measure foot health-related quality of life.
Measured: 18 months
plantar pressure
Plantar pressure measurements will be used to identify specific areas of high pressure under the foot. Plantar forces and pressures will be recorded during level barefoot walking using the TekScan High Resolution (HR) MatScan system.
Measured: 18 months
step count
Step count will be assessed via accelerometer
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 posted5 Feb 2015 (estimated)
- Study start3 Sep 2015
- Primary completion30 Jun 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Sundar Natarajan, MD MSc, Principal investigator, Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02356848
- Sponsor's protocol ID
- E1858-R
- Acronym
- STEP UP
- Status last verified
- Oct 2021
- First submitted
- 2 Feb 2015
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STEP UP to Avert Amputation in Diabetes
- ClinicalTrials.gov ID
- NCT02356848
- Acronym / sponsor ID
- STEP UP / E1858-R
- Conditions
- Diabetes, Foot Ulcer
- Keywords
- self-care, self-monitoring, secondary prevention, foot ulcer, Diabetic Foot Ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 3 Sep 2015 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 5 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 will evaluate a comprehensive tailored behavioral intervention aimed to improve foot self-care and self-monitoring (combined with dermal thermometry) to prevent recurrent ulcers in Veterans at highest risk of amputation. This intervention may be a novel strategy for improving self-care and early detection of foot abnormalities in this at-risk population using psychological theories to target multiple health behaviors simultaneously. This could be an efficient and cost-effective approach to improve diabetes-related foot health behavior, and other risk factors in patients who are vulnerable to devastating consequences related to amputation.
Detailed description
Veterans with diabetes who have had a previous ulcer are at highest risk for new ulcers and amputation, particularly if they have neuropathy or vascular disease and have poor foot self-care or nonadherence to diet, medication, and exercise recommendations. It is difficult to activate at-risk patients to improve self-care and detect foot abnormalities or inflammation at an early stage.
Proposed is a randomized controlled trial testing the effectiveness of a comprehensive tailored intervention (TI) aimed to improve self-care and self-monitoring (including dermal thermometry) through behavioral counseling. The primary specific aim is to evaluate if TI reduces the proportion of recurrent ulcers at 18 months compared to the current practice (CP) group. The secondary specific aims are to evaluate the impact of TI on time to ulceration, quality of life (QOL), plantar pressure, physical activity and foot care skills compared to the CP group.
The investigators will recruit adults with diabetes who have had a previously healed ulcer. The intervention will be standardized and fidelity of the intervention will be maintained. Using a blinded randomized controlled trial (RCT), the investigators will test the effect of TI in relation to CP. Key outcomes are ulceration, quality of life (QOL), plantar pressure, physical activity and foot care skills. Outcomes will be measured at baseline, 6, 12 and 18 months. All analyses will be intent-to-treat.
This study will evaluate a comprehensive tailored intervention targeting multiple behaviors related to self-care and amputation risk. This study applies advanced behavioral theories to intervene to improve care for veterans at risk for amputation combined with dermal thermometry. If this promising theory-driven approach can work in a clinical setting where improvements in foot care are urgently needed for these vulnerable Veterans with a previous ulcer, it will be an important scientific contribution that could lower the risk of recurrent ulcers and amputation in Veterans with diabetes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tailored intervention (TI) | Experimental | Behavioral: Tailored Intervention (TI)Participants in this arm will receive a comprehensive intervention based on the Transtheoretical Model and Prospect Theory with the counseling being delivered by health counselors using MI principles. This arm will have biweekly calls for the first two months and then monthly calls for the next four months followed by texts or mailings for months 7-18 with the frequency determine by level of treatment adherence. |
| Current Practice (CP) | Placebo comparator | Behavioral: Current Practice (CP)This group will receive all the enhancements that the VA has targeted to improve foot risk in diabetes including full EMR functionality, clinical reminders to improve care, and Patient-Centered Medical Home (PCMH) implementation with its benefits for diabetes care. To control for attention and preserve blinding, this group will receive calls and mailings focusing on providing education and prevention strategies for health conditions such as colorectal cancer, influenza, insomnia, vision, dementia, and oral disease. This arm will have biweekly calls for the first two months and then monthly calls for the next four months followed by texts or mailings for months 7-18 with the frequency determine by level of treatment adherence to general health recommendations |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults (21 years) with Type 2 diabetes
- History of healed diabetic foot ulcer (>3 months)
- Diabetes therapy for > 6 months
- An available phone and receiving continuity of care at the VA (at least 2 primary care visits in the previous 1.5 years at the recruitment site)
Key exclusion criteria (8 listed)
- Patients with an active foot ulcer
- Acute cardiovascular disease (CVD) events < 3 months ago
- Poor estimated short-term survival (< 1 year)
- Recent major surgery (< 3 months)
- Prior foot amputation
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 |
|---|---|---|
| Tailored Intervention (TI)Participants in this arm will receive a comprehensive intervention based on the Transtheoretical Model and Prospect Theory with the counseling being delivered by health counselors using MI principles. | Behavioural | Tailored intervention (TI) |
| Current Practice (CP)this group will receive calls and mailings focusing on providing education and prevention strategies for health conditions such as colorectal cancer, influenza, insomnia, vision, dementia, and oral disease. | Behavioural | Current Practice (CP) |
Primary outcome
Ulceration
Time frame: 18 months
High-resolution standard view digital photographs of the feet and footwear will be obtained and reviewed by the investigators blinded to group assignment, and a suspected ulcer or nonulcerative plantar lesion below the malleoli will be referred to a panel of three blinded (as to group assignment) adjudicators, all clinical experts. Lesions will be judged as absent/nonulcerative lesion/ulcer; involving/not involving the plantar surface (defined as involving the weight-bearing surface of the foot); and related to metatarsal head (MTH)/not related to MTH. Adjudicators will not confer with each other or with the study staff, and the majority opinion will be taken as the final judgment. Ulcers will be judged to be present if the integrity of both the epidermis and dermis is broken. When ulcers occur in between study visits, the adjudication committee will review the medical records and make the determination.
5 secondary outcomes
Foot care skills
Time frame: 18 months
General Quality of Life
Time frame: 18 months
Foot health-specific quality of life
Time frame: 18 months
plantar pressure
Time frame: 18 months
step count
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 8 Oct 2021.
- 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.
Sundar Natarajan, MD MSc principal investigator
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored Intervention (TI) and Current Practice (CP) in people with Diabetes and Foot Ulcer, run by VA Office of Research and Development 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 4 inclusion and 8 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 8 Oct 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. 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?
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?
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 8 Oct 2021.