Diabetic Foot UlcerNCT04280016
The Effect of Exercise on Wound Healing While Off-loading
A study testing Exercise in people with Diabetic Foot Ulcer, run by Mercer University at 1 site in United States.
Trial summary
This study seeks to establish the effect of adding exercise to off-loading interventions on the healing time for people with diabetes mellitus and a foot ulcer. Hypothesis: Consistent with the literature, results are expected to resemble the accelerated healing seen when older adults exercised in the presence of… 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?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2021to May 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
- Have diabetes
- Have an active plantar ulceration
- With or without peripheral neuropathy
- Able to safely exercise
- Receiving care for their plantar ulceration, including off-loading
Who cannot join
- Presence of an untreated infection, 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 Exercise on Wound Healing in People With Diabetes Undergoing Off-loading Treatment
This study seeks to establish the effect of adding exercise to off-loading interventions on the healing time for people with diabetes mellitus and a foot ulcer. Hypothesis: Consistent with the literature, results are expected to resemble the accelerated healing seen when older adults exercised in the presence of wounds.
Read the detailed description
The purpose of this project is to establish the effect of the addition of exercise to an off-loading intervention on the healing time for people with diabetes mellitus and a foot ulcer.
While benefits of physical activity and exercise are clear, the benefit of exercise on wound healing in individuals with diabetes has not been elucidated. It is critical to better understand how prescribed exercise effects the healing speed in patients receiving wound care with appropriate off-loading. If exercise does decrease healing time, the benefit to the patient may include lower cost, decreased risk of infection, decreased burden on a caregiver, and improved quality of life.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Exercise
- Keywords
- Diabetes, off-loading, exercise
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Participants will participate in an exercise session with non-weight-bearing exercise that the participant is able to perform with off-loading (e.g. total contact cast) intact. They will also be instructed in a home exercise program so that exercise can be performed three days per week with no more than two days between sessions. These participants will also receive standard wound care with off-loading.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Added to Off-loading | Experimental | Participants in this arm will participate in exercise at the healthcare facility one time a week (away from where wound care is provided) and be instructed in a home exercise program that they will be encouraged to perform at least three days per week with no more than two days between sessions. Wound care will continue at the facility as is standard, utilizing off-loading. Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound measurement size
Charts will be reviewed for normal wound measurements as is part of standard care. Measurements are expected to be reported as surface area (cm^2) and/or volume (cm^3). Wound closure will be defined as epithelialization across the entire wound bed and would be expected to correlate to no surface area or volume of wound being reported.
Measured: Measurements of wound will be taken up to 12 weeks or until wound closure occurs, whichever is first.
Secondary outcomes (5)
Summary of Diabetes Self-Care Activities Scale
Participation in exercise. Using two questions, this scale measures the number of days that an individual reports doing physical activity (question 1) or specific exercise (question 2). Scores on each question could range from 0 to 7 days. The higher the number, the more days the individual participates in the activity or exercise.
Measured: Measurement will be taken at baseline and at end of study (at 12 weeks or at wound closure, whichever occurs first).
Body Mass Index
Height and weight measurements will be combined and reported as BMI and measured in kg/m^2.
Measured: Measurement will be taken at baseline and at end of study (at 12 weeks or at wound closure, whichever occurs first).
Physical activity data using an activity monitor (e.g. StepWatch).
A week-long measurement of strides will be taken at the begin of the study.
Measured: Measured at baseline for one week.
Vibration sense
Vibration sense will be measured using a Bio-Thesiometer to assess for degree of peripheral neuropathy. A higher score would indicate decreased sensory perception of vibration.
Measured: Measurement will be taken at baseline and at end of study (at 12 weeks or at wound closure, whichever occurs first).
Waist circumference
Waist circumference will be taken in cm as a marker of body composition.
Measured: Measurement will be taken at baseline and at end of study (at 12 weeks or at wound closure, whichever occurs first).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start14 May 2021
- Primary completionMay 2023 (estimated)
- Study completionMay 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A pilot study using retrospective chart review and non-randomized controlled trial methodology (single group).
- Masking
- None (open label)
- Enrolment
- 15 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
- NCT04280016
- Sponsor's protocol ID
- H1908192
- 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 closure rate 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 Exercise on Wound Healing in People With Diabetes Undergoing Off-loading Treatment
- ClinicalTrials.gov ID
- NCT04280016
- Acronym / sponsor ID
- H1908192
- Conditions
- Diabetic Foot Ulcer
- Keywords
- Diabetes, off-loading, exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Mercer UniversityUniversity, hospital or other
- Study start
- 14 May 2021 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 21 Feb 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 seeks to establish the effect of adding exercise to off-loading interventions on the healing time for people with diabetes mellitus and a foot ulcer. Hypothesis: Consistent with the literature, results are expected to resemble the accelerated healing seen when older adults exercised in the presence of wounds.
Detailed description
The purpose of this project is to establish the effect of the addition of exercise to an off-loading intervention on the healing time for people with diabetes mellitus and a foot ulcer.
While benefits of physical activity and exercise are clear, the benefit of exercise on wound healing in individuals with diabetes has not been elucidated. It is critical to better understand how prescribed exercise effects the healing speed in patients receiving wound care with appropriate off-loading. If exercise does decrease healing time, the benefit to the patient may include lower cost, decreased risk of infection, decreased burden on a caregiver, and improved quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A pilot study using retrospective chart review and non-randomized controlled trial methodology (single group).
| Arm | Type | Receives |
|---|---|---|
| Exercise Added to Off-loading | Experimental | Behavioral: ExerciseParticipants in this arm will participate in exercise at the healthcare facility one time a week (away from where wound care is provided) and be instructed in a home exercise program that they will be encouraged to perform at least three days per week with no more than two days between sessions. Wound care will continue at the facility as is standard, utilizing off-loading. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have diabetes
- Have an active plantar ulceration
- With or without peripheral neuropathy
- Able to safely exercise
- Receiving care for their plantar ulceration, including off-loading
Key exclusion criteria (1 listed)
- Presence of an untreated infection, 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 |
|---|---|---|
| ExerciseParticipants will participate in an exercise session with non-weight-bearing exercise that the participant is able to perform with off-loading (e.g. total contact cast) intact. They will also be instructed in a home exercise program so that exercise can be performed three days per week with no more than two days between sessions. These participants will also receive standard wound care with off-loading. | Behavioural | Exercise Added to Off-loading |
Primary outcome
Wound measurement size
Time frame: Measurements of wound will be taken up to 12 weeks or until wound closure occurs, whichever is first.
Charts will be reviewed for normal wound measurements as is part of standard care. Measurements are expected to be reported as surface area (cm^2) and/or volume (cm^3). Wound closure will be defined as epithelialization across the entire wound bed and would be expected to correlate to no surface area or volume of wound being reported.
5 secondary outcomes
Summary of Diabetes Self-Care Activities Scale
Time frame: Measurement will be taken at baseline and at end of study (at 12 weeks or at wound closure, whichever occurs first).
Body Mass Index
Time frame: Measurement will be taken at baseline and at end of study (at 12 weeks or at wound closure, whichever occurs first).
Physical activity data using an activity monitor (e.g. StepWatch).
Time frame: Measured at baseline for one week.
Vibration sense
Time frame: Measurement will be taken at baseline and at end of study (at 12 weeks or at wound closure, whichever occurs first).
Waist circumference
Time frame: Measurement will be taken at baseline and at end of study (at 12 weeks or at wound closure, whichever occurs first).
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 closure rate 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 Exercise 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 5 inclusion and 1 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?
Wound measurement size (time frame: Measurements of wound will be taken up to 12 weeks or until wound closure occurs, whichever is first.). 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.