Diabetic FootEFADDIAPNCT04582357
Physical Activity Assessment of Patients With Diabetic Foot Wounds
A study testing Physical activity program in people with Diabetic Foot, run by University Hospital, Lille.
Trial summary
The study evaluates the compliance of patients who suffer from a diabetic foot wound to follow a physical activity program, adapted to their medical condition. This study will aslo evaluate the security of this program, and how it could improve or not the quality of life, the diabet's metabolical balance, and the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot
- What is being tested?
- Physical activity program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2020to Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women
- Every patient over 18 years old
- Diabet whatever the type, with foot wound, whatever the size, or duration.
Who cannot join
- Medical condition : sub-gonal amputation, which makes physical activity impossible. Wound localization which would lead to a wound degradation, like the heel, the plantar face of toes.
- Administrative cause : impossibility to provide written informed consent, impossibility to be followed up during the needed duration, no medical insurance, rejection to sign the consent paper.
About this study
Official title: Offloaded Physical Activity Program Feasibility Assessment of Patients With Diabetic Foot Wounds
The study evaluates the compliance of patients who suffer from a diabetic foot wound to follow a physical activity program, adapted to their medical condition.
This study will aslo evaluate the security of this program, and how it could improve or not the quality of life, the diabet's metabolical balance, and the wounds's cicatrization speed.
Read the detailed description
The study is a prospective monocentric study, leaded in the Lille CHRU. this study is a physical activity program feasibility assessment for patients with diabetic foot wounds. The muscular mass stabilization and the physical activity is almost never used to heal diabetic feet wounds. With this study, we evaluate the compliance of patients to follow a physical activity program, which could lead to a further study, with more patients and multicentric, and it could measure the impact of this program on metabolical balance, wound size and quality of life.
The study will last 6 months, the inclusion will last 3 months, and each patient will have a 3 months follow-up time. The patient have several medical appointments in the diabetic foot unit, where the compliance will be evaluated, wound size and security will also be evaluated.
The activity program is a suite of exercises, 4 times in a week, it lasts 30 minutes?
The first day, follow-up book is given to the patient. During the follow-up, the patient will still have his usual medical appointments, which will occur at the 30th, 60th and 90th days.
Phone-call appointments will also be possible at the 15th and 45th days.
- Conditions
- Diabetic Foot
- Being tested
- Physical activity program
- Keywords
- Diabetic foot, Physical activity, Muscular mass, Cicatrization, Offloading
- Medical subject headings
- Diabetic Foot, Motor Activity, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity programBehavioural
The physical activity program is a suite of several exercises which intend to improve muscular mass of targeted muscles.
| Study group | Role | What they receive |
|---|---|---|
| Exercise arm | Experimental | This arm is the only arm of the study, every patient is included in this arm, the patients will follow the physical activity program Receives: Behavioral: Physical activity program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity program attendance
This outcome will evaluate the rate of patients who followed the whole physical activity program, with the help of a log book, which will be given to the patient at the first appointment
Measured: 3 months
Secondary outcomes (4)
Glycated hemoglobin variation
Evaluation of the glycated hemoglobin before inclusion and at the end of the study, to evaluate the diabet's metabolical balance
Measured: 3 months
Wound size variation
The wound is measured with a graduated scale before inclusion and at the end of the study, the main axis is used to define the size
Measured: 3 months
Quality of life variation
The quality of life will be measured with a simple survey before inclusion and at the end of the study, the survey is the DFS scale. the DFS evaluates the quality of life with questions like emotional impact, pain, personal satisfaction
Measured: 3 months
Security
Patients will report any unexpected event or any injury in the log book, like hypoglycaemia or pain
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study startDec 2020 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Why it stopped: sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence Baudoux, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04582357
- Sponsor's protocol ID
- 2019_67
- Other IDs
- 2020-A02274-35
- Acronym
- EFADDIAP
- Status last verified
- Sep 2020
- First submitted
- 5 Oct 2020
- Last updated
- 18 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Offloaded Physical Activity Program Feasibility Assessment of Patients With Diabetic Foot Wounds
- ClinicalTrials.gov ID
- NCT04582357
- Acronym / sponsor ID
- EFADDIAP / 2019_67
- Conditions
- Diabetic Foot
- Keywords
- Diabetic foot, Physical activity, Muscular mass, Cicatrization, Offloading
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: sponsor decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- Dec 2020 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 9 Oct 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.
The study evaluates the compliance of patients who suffer from a diabetic foot wound to follow a physical activity program, adapted to their medical condition.
This study will aslo evaluate the security of this program, and how it could improve or not the quality of life, the diabet's metabolical balance, and the wounds's cicatrization speed.
Detailed description
The study is a prospective monocentric study, leaded in the Lille CHRU. this study is a physical activity program feasibility assessment for patients with diabetic foot wounds. The muscular mass stabilization and the physical activity is almost never used to heal diabetic feet wounds. With this study, we evaluate the compliance of patients to follow a physical activity program, which could lead to a further study, with more patients and multicentric, and it could measure the impact of this program on metabolical balance, wound size and quality of life.
The study will last 6 months, the inclusion will last 3 months, and each patient will have a 3 months follow-up time. The patient have several medical appointments in the diabetic foot unit, where the compliance will be evaluated, wound size and security will also be evaluated.
The activity program is a suite of exercises, 4 times in a week, it lasts 30 minutes?
The first day, follow-up book is given to the patient. During the follow-up, the patient will still have his usual medical appointments, which will occur at the 30th, 60th and 90th days.
Phone-call appointments will also be possible at the 15th and 45th days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise arm | Experimental | Behavioral: Physical activity programThis arm is the only arm of the study, every patient is included in this arm, the patients will follow the physical activity program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women
- Every patient over 18 years old
- Diabet whatever the type, with foot wound, whatever the size, or duration.
Key exclusion criteria (2 listed)
- Medical condition : sub-gonal amputation, which makes physical activity impossible. Wound localization which would lead to a wound degradation, like the heel, the plantar face of toes.
- Administrative cause : impossibility to provide written informed consent, impossibility to be followed up during the needed duration, no medical insurance, rejection to sign the consent paper.
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 |
|---|---|---|
| Physical activity programThe physical activity program is a suite of several exercises which intend to improve muscular mass of targeted muscles. | Behavioural | Exercise arm |
Primary outcome
Physical activity program attendance
Time frame: 3 months
This outcome will evaluate the rate of patients who followed the whole physical activity program, with the help of a log book, which will be given to the patient at the first appointment
4 secondary outcomes
Glycated hemoglobin variation
Time frame: 3 months
Wound size variation
Time frame: 3 months
Quality of life variation
Time frame: 3 months
Security
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
Related trials for Diabetic Foot
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Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
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Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
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Better Care Closer to Home: Enhancing Primary and Community Care
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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.
Florence Baudoux, MD principal investigator
University Hospital, Lille
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity program in people with Diabetic Foot, run by University Hospital, Lille.
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 2 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: withdrawn, as of the sponsor's last update on 18 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Physical activity program attendance (time frame: 3 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 18 Oct 2022.