Diabetic Foot UlcerNCT04310137
Self-directed Versus Therapist-directed Re-loading on Incidence of Ulcer Recurrence
A study testing Therapist-Directed Re-loading in people with Diabetic Foot Ulcer, run by Mercer University at 1 site in United States.
Trial summary
This study is designed to evaluate if how people are told to return to walking after a skin injury affects whether or not they develop new (recurrence) skin breakdown on their feet. The people in this study will have diabetes and have a recently closed foot ulcer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Therapist-Directed Re-loading
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2021to Dec 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- With or without peripheral neuropathy
- Able to safely exercise
- Have a recently closed plantar ulceration
Who cannot join
- Presence of an open plantar ulceration
- Presence of an untreated infection
- Presence of osteomyelitis or gangrene
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Piedmont Healthcare
Atlanta, Georgia, 30309
Teri Biven, DPT, 404-605-2743, Teri.Biven@piedmont.org
About this study
Official title: The Effect of Self-directed Versus Therapist-directed Re-loading on Incidence of Ulcer Recurrence
This study is designed to evaluate if how people are told to return to walking after a skin injury affects whether or not they develop new (recurrence) skin breakdown on their feet. The people in this study will have diabetes and have a recently closed foot ulcer. About half will be specifically told how to return to walking and the other half will be told to return to walking slowly. How people naturally return to walking will also be established.
Read the detailed description
The purpose of this project is to determine the impact of Therapist-directed loading versus self-selected loading on ulcer occurrence and to establish natural loading behavior following diabetic foot ulcer closure.
Eligible participants will be randomized into a group given specific directions from a Therapist to return to walking (i.e. reloading skin following plantar ulceration closure) or a group encouraged to slowly return to walking (self-directed re-loading of the skin following plantar ulceration closure). Following randomization and instruction for re-loading according to group assignment, participants will be assessed every 6 months for walking behavior. Participants will be monitored for ulcer recurrence throughout. Participants will be followed for up to 18 months.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Therapist-Directed Re-loading
- Keywords
- Diabetes, re-loading, ulcer recurrence
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapist-Directed Re-loadingBehavioural
Therapist will specifically direct participant to increase walking by 10% as measured at each of the activity monitoring assessments. In addition, the participant will be asked to monitor foot temperature to mitigate risk for breakdown.
| Study group | Role | What they receive |
|---|---|---|
| Therapist-Directed Re-loading | Experimental | Participants in this arm will be instructed to increase their activity by walking 10% more steps per day than the steps recorded in the most recent activity monitoring (i.e. StepWatch) measurement (e.g. 10% more than the initial monitoring values and 10% more than the second monitoring values once they are completed). Receives: Behavioral: Therapist-Directed Re-loading |
| Self-Directed Re-loading | No intervention | Participants in this arm will be instructed to slowly increase their walking. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Ulcer Recurrence
Assessment of incidence of any plantarr ulcer recurrence.
Measured: Over up to 18 months of follow-up.
Change in walking behavior (steps)
Actual assessment of change in walking behavior will be assessed by number of steps.
Measured: Assessed initially and every 6 months for 1 week for up to 18 months.
Change in walking behavior (step timing)
Actual assessment of change in walking behavior will be assessed by the timing of steps (how many steps in a given timeframe).
Measured: Assessed initially and every 6 months for 1 week for up to 18 months.
Secondary outcomes (4)
Exercise component of Summary of Diabetes Self-Care Activities Scale
Questionnaire to assess exercise adherence. It is a report of the number of days that an individual participates in physical activity as well as specific exercise (2 questions). The higher the number, the more days of activity/exercise participation. The more days of participation, the better the investigators would expect health to be.
Measured: Assessed initially and every 6 months for up to 18 months
Bio-thesiometer
Assesses vibration sense
Measured: Assessed initially and every 6 months for up to 18 months
Body Mass Index (BMI) and disease risk
Weight and height will be combined to report BMI in kg/m^2.
Measured: Assessed initially and every 6 months for up to 18 months
Waist circumference
Waist circumference (measured in cm) will be assessed for change over time.
Measured: Assessed initially and every 6 months for up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start1 May 2021
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mercer University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deborah M. Wendland, Ph.D., Mercer University
- Investigators
- Deborah M. Wendland, Principal investigator, Mercer University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04310137
- Sponsor's protocol ID
- H1908191
- Status last verified
- Oct 2021
- First submitted
- 19 Feb 2020
- Last updated
- 25 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified step data will be made available through a repository upon conclusion of the study and its dissemination.
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Self-directed Versus Therapist-directed Re-loading on Incidence of Ulcer Recurrence
- ClinicalTrials.gov ID
- NCT04310137
- Acronym / sponsor ID
- H1908191
- Conditions
- Diabetic Foot Ulcer
- Keywords
- Diabetes, re-loading, ulcer recurrence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mercer UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 17 Mar 2020 (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.
This study is designed to evaluate if how people are told to return to walking after a skin injury affects whether or not they develop new (recurrence) skin breakdown on their feet. The people in this study will have diabetes and have a recently closed foot ulcer. About half will be specifically told how to return to walking and the other half will be told to return to walking slowly. How people naturally return to walking will also be established.
Detailed description
The purpose of this project is to determine the impact of Therapist-directed loading versus self-selected loading on ulcer occurrence and to establish natural loading behavior following diabetic foot ulcer closure.
Eligible participants will be randomized into a group given specific directions from a Therapist to return to walking (i.e. reloading skin following plantar ulceration closure) or a group encouraged to slowly return to walking (self-directed re-loading of the skin following plantar ulceration closure). Following randomization and instruction for re-loading according to group assignment, participants will be assessed every 6 months for walking behavior. Participants will be monitored for ulcer recurrence throughout. Participants will be followed for up to 18 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Therapist-Directed Re-loading | Experimental | Behavioral: Therapist-Directed Re-loadingParticipants in this arm will be instructed to increase their activity by walking 10% more steps per day than the steps recorded in the most recent activity monitoring (i.e. StepWatch) measurement (e.g. 10% more than the initial monitoring values and 10% more than the second monitoring values once they are completed). |
| Self-Directed Re-loading | No intervention | –Participants in this arm will be instructed to slowly increase their walking. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- With or without peripheral neuropathy
- Able to safely exercise
- Have a recently closed plantar ulceration
Key exclusion criteria (3 listed)
- Presence of an open plantar ulceration
- Presence of an untreated infection
- Presence of osteomyelitis or gangrene
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 |
|---|---|---|
| Therapist-Directed Re-loadingTherapist will specifically direct participant to increase walking by 10% as measured at each of the activity monitoring assessments. In addition, the participant will be asked to monitor foot temperature to mitigate risk for breakdown. | Behavioural | Therapist-Directed Re-loading |
Primary outcome
Incidence of Ulcer Recurrence
Time frame: Over up to 18 months of follow-up.
Assessment of incidence of any plantarr ulcer recurrence.
Change in walking behavior (steps)
Time frame: Assessed initially and every 6 months for 1 week for up to 18 months.
Actual assessment of change in walking behavior will be assessed by number of steps.
Change in walking behavior (step timing)
Time frame: Assessed initially and every 6 months for 1 week for up to 18 months.
Actual assessment of change in walking behavior will be assessed by the timing of steps (how many steps in a given timeframe).
4 secondary outcomes
Exercise component of Summary of Diabetes Self-Care Activities Scale
Time frame: Assessed initially and every 6 months for up to 18 months
Bio-thesiometer
Time frame: Assessed initially and every 6 months for up to 18 months
Body Mass Index (BMI) and disease risk
Time frame: Assessed initially and every 6 months for up to 18 months
Waist circumference
Time frame: Assessed initially and every 6 months for up to 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2021.
- Individual participant dataSharing planned: Yes. De-identified step data will be made available through a repository upon conclusion of the study and its dissemination.
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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.
Deborah M. Wendland principal investigator
Mercer University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapist-Directed Re-loading in people with Diabetic Foot Ulcer, run by Mercer University 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 3 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: status not confirmed, as of the sponsor's last update on 25 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Deborah M. Wendland, PhD (6785476775, wendland_dm@mercer.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Ulcer Recurrence (time frame: Over up to 18 months of follow-up.). The study lists 3 primary outcomes in all. 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 25 Oct 2021.