Leg UlcersFOOTFITNCT02632695

Physical Activity Interventions for Leg Ulcer Patients

A study testing FOOTFIT in people with Leg Ulcers and Venous Ulcers, run by Medical University of South Carolina at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 55 years and older
Conditions the study is for: Leg Ulcers, Venous Ulcers, Varicose Ulcers
What is being tested?: FOOTFIT
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteUnited States
Study dates: Apr 2015to 31 Aug 2018
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 55 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Active venous leg ulcer
Ankle brachial index 0.80 to 1.3 mmHg, a measure of arterial sufficiency
Sedentary-able to only walk a few steps at a time or not farther than 10 feet
Not currently exercising or participate in a PA or physical therapy program
Receives at least weekly wound care anticipated to last for at least six weeks from start of study
Able to don accelerometer - if unable to apply independently, has assistance from other
Capable of using Smartphone

Who cannot join

Co-morbid conditions such as stroke (limits ankle function)
Ulcer from other causes (arterial, diabetic, trauma, surgery)
Documented cognitive impairment (MiniCog)
No 3G service in area where patient resides

Trial locations and contacts

1 site in 1 country.

United States1 site

Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303

Other trials in United States

About this study

The goal of this study is to test FOOTFIT and enhanced FOOTFIT+, home-based mobile health (mHealth) physical activity (PA) interventions for a minimally ambulatory, chronically-ill, population with leg ulcers. A highly sensitive clinically designed Bluetooth® enabled accelerometer and tracking device (BEAT) worn on the foot during a progressive and evidence-based non-exertive leg conditioning activities for lower leg function (CALF) captures minute foot movements and sends the data to a Smartphone. This six-week feasibility study will compare FOOTFIT to FOOTFIT+, with the added connectivity feature, to promote patient-provider communication, evaluate adherence to PA, and assess signals of efficacy on functional outcomes in a very low fitness population.

Read the detailed description

FOOTFIT is a study of a lower leg conditioning mHealth intervention for patients with venous leg ulcers. The aims are to compare two versions, one of which is enhanced (FOOTFIT+), to determine which has the greatest impact on physical activity adherence, patient-provider communication, and leg function. FOOTFIT and FOOTFIT+ share three components: 1) a low-cost, tri-axial Bluetooth® enabled highly sensitive accelerometer and tracking device (BEAT) worn on the foot during, 2) phased conditioning activities for lower leg function (CALF) tracked by a, 3) Smartphone that captures signals from BEAT, provides motivational messages, CALF instruction, and automated feedback on progress. Forty patients will be targeted in this six-week study, 20 of which will receive FOOTFIT and 20 FOOTFIT+.

Conditions: Leg Ulcers, Venous Ulcers, Varicose Ulcers
Being tested: FOOTFIT
Medical subject headings: Leg Ulcer, Varicose Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FOOTFITDevice
Individuals with venous leg ulcers will be instructed on physical activity movements for their lower legs to be performed over six weeks while wearing a foot based activity monitor (accelerometer) that will send them motivational messages and progress reports. For those in the FOOTFIT Plus group, individuals will have the option to communicate with their wound care provider via text messages, emails or phone calls.

Study groups in NCT02632695
Study group	Role	What they receive
FOOTFIT Plus	Experimental	The intervention consists of: 1) a prescribed, evidence-based, phased, non-exertive physical activity conditioning activities for lower leg function (CALF) movements that are to be performed daily at home; 2) a low-cost, tri-axial Bluetooth® enabled highly sensitive motion-sensing accelerometer and tracking device (BEAT) worn on the foot during CALF to capture frequency and intensity of foot movements; and 3) a Smartphone that receives foot movement data, provides automated educational/motivational messages, and reports and allows regular communication with the wound care provider on progress. Receives: Device: FOOTFIT
FOOTFIT	Experimental	The intervention consists of: 1) a prescribed, evidence-based, phased, non-exertive physical activity conditioning activities for lower leg function (CALF) movements that are to be performed daily at home; 2) a low-cost, tri-axial Bluetooth® enabled highly sensitive motion-sensing accelerometer and tracking device (BEAT) worn on the foot during CALF to capture frequency and intensity of foot movements; and 3) a Smartphone that receives foot movement data, provides automated educational/motivational messages, and reports. There is not regular communication with the wound care provider on progress. Receives: Device: FOOTFIT

What is being measured

The primary outcome is the main question the study is designed to answer.

FOOTFIT feasibility
Measure adherence by recording frequency and intensity of foot/toe movements reported in minutes.
Measured: 6 weeks
FOOTFIT reach
Measure reach, recorded as qualitative documents on a log of how patients learned about the study.
Measured: 6 weeks
FOOTFIT technology implementation procedures
Record on study log the number and types of problems encountered with the study nurses teaching participants to use the foot accelerometer technology, the number and types problems reported by patient, the number and types of recommendations made by the participant regarding the use of the accelerometer, and nurse or provider recommendations for changes to refine the foot accelerometer technology, and the number and types of refinements to the technology that were made.
Measured: 6 weeks
FOOTFIT acceptability
Record on study logs the the number (frequency) and types of interactions such as phone calls, emails or texts, between the patient and provider regarding FOOTFIT+ including reasons (i.e., exercises, adverse events that are related to, and not related to the use of the accelerometer).
Measured: 6 weeks

Secondary outcomes (5)

Efficacy on pain
Obtain estimates of variability for short-term functional impacts on pain using the numerical rating scale (NRS) as a single score.
Measured: 6 weeks
Efficacy on foot strength
Obtain estimates of variability for short-term functional impacts on foot strength using the dynamometer and reported as pounds per square inch.
Measured: 6 weeks
Efficacy on foot range of motion.
Obtain estimates of variability for short-term functional impacts on foot range of motion using the goniometer and reported in degrees.
Measured: 6 weeks
Efficacy on walking function.
Obtain estimates of variability for short-term functional impacts on walking function using the Foot and Ankle Ability Measure and reported as a sum score.
Measured: 6 weeks
Efficacy on walking performance
The Six Minute Walk Test reported as distance in feet over six minutes time.
Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 201531 Aug 2018

First posted17 Dec 2015 (estimated)
Study startApr 2015
Primary completion31 Aug 2018
Study completion31 Aug 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Leg UlcersStudies 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: Supportive care
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02632695
Sponsor's protocol ID: Pro00043451
Acronym: FOOTFIT
Status last verified: May 2018
First submitted: 1 Dec 2015
Last updated: 7 Sep 2018
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Kelechi TJ, Prentice MA, Mueller M, Madisetti M, Vertegel A. A Lower Leg Physical Activity Intervention for Individuals With Chronic Venous Leg Ulcers: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 May 15;8(5):e15015. doi: 10.2196/15015.
PubMed 32412419

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Comparison of Negative Pressure Wound Therapy Versus Moist Wound Dressing in Diabetic Foot Ulcer Patients
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All Leg Ulcers trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Physical Activity Interventions for Leg Ulcer Patients
ClinicalTrials.gov ID: NCT02632695
Acronym / sponsor ID: FOOTFIT / Pro00043451
Conditions: Leg Ulcers, Venous Ulcers, Varicose Ulcers
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Medical University of South CarolinaUniversity, hospital or other
Study start: Apr 2015
Primary completion: 31 Aug 2018 (actual)
Study completion: 31 Aug 2018 (actual)
First posted: 17 Dec 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.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
FOOTFIT Plus	Experimental	Device: FOOTFITThe intervention consists of: 1) a prescribed, evidence-based, phased, non-exertive physical activity conditioning activities for lower leg function (CALF) movements that are to be performed daily at home; 2) a low-cost, tri-axial Bluetooth® enabled highly sensitive motion-sensing accelerometer and tracking device (BEAT) worn on the foot during CALF to capture frequency and intensity of foot movements; and 3) a Smartphone that receives foot movement data, provides automated educational/motivational messages, and reports and allows regular communication with the wound care provider on progress.
FOOTFIT	Experimental	Device: FOOTFITThe intervention consists of: 1) a prescribed, evidence-based, phased, non-exertive physical activity conditioning activities for lower leg function (CALF) movements that are to be performed daily at home; 2) a low-cost, tri-axial Bluetooth® enabled highly sensitive motion-sensing accelerometer and tracking device (BEAT) worn on the foot during CALF to capture frequency and intensity of foot movements; and 3) a Smartphone that receives foot movement data, provides automated educational/motivational messages, and reports. There is not regular communication with the wound care provider on progress.

Who may qualify

Ages: 55 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Active venous leg ulcer
Ankle brachial index 0.80 to 1.3 mmHg, a measure of arterial sufficiency
Sedentary-able to only walk a few steps at a time or not farther than 10 feet
Not currently exercising or participate in a PA or physical therapy program
Receives at least weekly wound care anticipated to last for at least six weeks from start of study

Key exclusion criteria (4 listed)

Co-morbid conditions such as stroke (limits ankle function)
Ulcer from other causes (arterial, diabetic, trauma, surgery)
Documented cognitive impairment (MiniCog)
No 3G service in area where patient resides

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
FOOTFITIndividuals with venous leg ulcers will be instructed on physical activity movements for their lower legs to be performed over six weeks while wearing a foot based activity monitor (accelerometer) that will send them motivational messages and progress reports. For those in the FOOTFIT Plus group, individuals will have the option to communicate with their wound care provider via text messages, emails or phone calls.	Device	FOOTFIT, FOOTFIT Plus

Primary outcome

FOOTFIT feasibility
Time frame: 6 weeks
Measure adherence by recording frequency and intensity of foot/toe movements reported in minutes.
FOOTFIT reach
Time frame: 6 weeks
Measure reach, recorded as qualitative documents on a log of how patients learned about the study.
FOOTFIT technology implementation procedures
Time frame: 6 weeks
Record on study log the number and types of problems encountered with the study nurses teaching participants to use the foot accelerometer technology, the number and types problems reported by patient, the number and types of recommendations made by the participant regarding the use of the accelerometer, and nurse or provider recommendations for changes to refine the foot accelerometer technology, and the number and types of refinements to the technology that were made.
FOOTFIT acceptability
Time frame: 6 weeks
Record on study logs the the number (frequency) and types of interactions such as phone calls, emails or texts, between the patient and provider regarding FOOTFIT+ including reasons (i.e., exercises, adverse events that are related to, and not related to the use of the accelerometer).

5 secondary outcomes

Efficacy on pain
Time frame: 6 weeks
Efficacy on foot strength
Time frame: 6 weeks
Efficacy on foot range of motion.
Time frame: 6 weeks
Efficacy on walking function.
Time frame: 6 weeks
Efficacy on walking performance
Time frame: 6 weeks

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 7 Sep 2018.
Derived from this study: PubMed 32412419Kelechi TJ, Prentice MA, Mueller M, Madisetti M, Vertegel A. A Lower Leg Physical Activity Intervention for Individuals With Chronic Venous Leg Ulcers: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 May 15;8(5):e15015. doi: 10.2196/15015.

Related trials for Leg Ulcers

Active, not recruitingPhase 4
A Non-Randomized Open Label Clinical Trial Evaluating DermaBind TL
Diabetic Foot Ulcer (DFU), Venous Leg Ulcer (VLU)
Recruiting
Vacuum Compression Therapy and Tissue Oxygenation in Chronic Leg Ulcers
Leg Ulcers, Leg Ulcers Venous
Not yet recruiting
Comparison of Negative Pressure Wound Therapy Versus Moist Wound Dressing in Diabetic Foot Ulcer Patients
Diabetic Foot Ulcer
RecruitingPhase 4
Topical Sevoflurane for Treatment of Chronic Leg Ulcers
Leg Ulcer
Recruiting
Dose-Response Structured Calf Muscle Pump Activation Strategies Versus Unsupervised Home Walks
Venous Ulcer of Leg

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.

Moby Madisetti, MS study director

Medical University of South Carolina

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing FOOTFIT in people with Leg Ulcers and Venous Ulcers, run by Medical University of South Carolina 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 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 7 Sep 2018. 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?

FOOTFIT feasibility (time frame: 6 weeks). The study lists 4 primary outcomes in all. 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 NCT02632695, which also lists 1 linked publication.

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 7 Sep 2018.