Back to resultsExercise Therapy for People With a Diabetic Foot Ulcer - a Feasibility Study
Primary Purpose
Diabetic Foot Ulcer, Diabetic Foot, Wound Healing Disorder
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Exercise Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Foot Ulcer
Eligibility Criteria
Inclusion Criteria:
- Adults aged 18 years or above
- Diabetes mellitus
- Non-surgical ulcer located distal to the malleoli
- Willingness to participate in a 12-week supervised exercise therapy intervention twice a week
- Prescribed with a therapeutic shoe, orthopaedic specialist shoe from the outpatient clinic or a specialized podiatrist.
Exclusion Criteria:
- Dementia or other reasons that cause inability to give informed consent
- People that are wheelchair-bound
- People with a prescribed cast or walker boot
- Unable to understand Danish.
- Diagnosed with or awaiting evaluation of suspected acute phase Charcot arthropathy or osteomyelitis
Sites / Locations
- SUH Køge
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Exercise therapy
Arm Description
Exercises will be performed with minimal weight bearing on foot soles, as recommended in the literature for people with diabetic peripheral neuropathy.
Outcomes
Primary Outcome Measures
Recruitment rate
will be analysed by dividing number of included participants (n = 15) by the number of months it took to include them (calculated from study start until the 15th participant is recruited).
Participant retention
will be evaluated by the number of participants showing up at 12-week follow up.
Exercise adherence
will be evaluated using exercise logs completed at each session by the physiotherapist covering load and intensity. Adherence will be calculated by counting number of exercise sessions completed in the exercise log, divided by 24 planned sessions, presented in percentage.
Adverse events
Safety will be assessed based on observed and patient-reported adverse events, and their relatedness to the index ulcer and to the exercise program.
Minor adverse events will cover muscle soreness or post-exercise fatigue. Whereas serious adverse events will cover all negative events related to the foot ulcer, and cover life- threatening events, disability, or permanent damage
Participant and physiotherapist feedback
will be provided at 12-week follow up on a custom-made interviews with open questions on acceptability of assessment procedures, treatment experience, and feedback about the supervised sessions and potential adverse events
30-second chair-stand test
To test leg strength and endurance of participants the 30-second chair-stand test will be performed at baseline and at the last day of follow-up.
Tandem Test
Balance will be evaluated with the Tandem Test at baseline and at the last day of follow-up.
Ulcer size
Ulcer size measurement is assessed on digital images with standardized measuring tape from participants last to the outpatient clinic visit prior to baseline and from participants last to the outpatient clinic visit to last day of follow-up. The measurement is a standard measurement in the outpatient clinic at every participant visit
Wound-QoL
Participants are asked to fill out the the Wound-QoL questionnaires in paper form at baseline and at the last day of follow-up
The Wound-QoL consists of 17 items that can be combined into three individual multi-item domains: Body, Psyche and Everyday life as well as a single-item domain on Economy
EC-5D-5L
Participants are asked to fill out the Danish versions of the patient-reported outcome measures (PROM) EQ-5D-5L in paper form at baseline and at the last day of follow-up.
The EQ-5D- 3L includes the European Quality of life visual analogue scale (EQ-VAS) where the patient's own health 'today' is rated between 0 (worst imaginable health) and 100 (best imaginable health)
4x10-meter fast-paced walk test
The 40 m FPWT is a test for performance on the activity short-distance walking. The test will be performed at baseline and at the last day of follow-up.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05101473
Brief Title
Exercise Therapy for People With a Diabetic Foot Ulcer - a Feasibility Study
Official Title
Exercise Therapy for People With a Diabetic Foot Ulcer - a Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
April 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Holbaek Sygehus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this feasibility study is to evaluate a 12-week exercise intervention in people with an active diabetic foot ulcer through pre-defined research progression criteria (participant recruitment and retention, duration of the collection of outcome measures, adherence to the exercise programme, and adverse events), besides participant and physiotherapist feedback, self-reported outcomes and objective measurements in preparation for a potential future RCT.
The primary study hypothesis is that exercise therapy for people with an active diabetic foot ulcer will have high participant recruitment and adherence to treatment and that it does not affect wound healing negatively.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer, Diabetic Foot, Wound Healing Disorder, Ulcer Foot, Ulcer Healing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The trial is a single-center single-group feasibility trial in outpatient clinical settings.
The trial will be reported with reference to the extended CONSORT guidelines.
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise therapy
Arm Type
Experimental
Arm Description
Exercises will be performed with minimal weight bearing on foot soles, as recommended in the literature for people with diabetic peripheral neuropathy.
Intervention Type
Other
Intervention Name(s)
Exercise Therapy
Intervention Description
The overall framework will consist of two supervised exercise sessions per week of 30-60 min duration for 12 weeks in order to be able to result in the physiological adaptions that are needed to improve the health of the individual participant.
Primary Outcome Measure Information:
Title
Recruitment rate
Description
will be analysed by dividing number of included participants (n = 15) by the number of months it took to include them (calculated from study start until the 15th participant is recruited).
Time Frame
6 month
Title
Participant retention
Description
will be evaluated by the number of participants showing up at 12-week follow up.
Time Frame
12-week follow up.
Title
Exercise adherence
Description
will be evaluated using exercise logs completed at each session by the physiotherapist covering load and intensity. Adherence will be calculated by counting number of exercise sessions completed in the exercise log, divided by 24 planned sessions, presented in percentage.
Time Frame
12-week follow up.
Title
Adverse events
Description
Safety will be assessed based on observed and patient-reported adverse events, and their relatedness to the index ulcer and to the exercise program.
Minor adverse events will cover muscle soreness or post-exercise fatigue. Whereas serious adverse events will cover all negative events related to the foot ulcer, and cover life- threatening events, disability, or permanent damage
Time Frame
12-week follow up.
Title
Participant and physiotherapist feedback
Description
will be provided at 12-week follow up on a custom-made interviews with open questions on acceptability of assessment procedures, treatment experience, and feedback about the supervised sessions and potential adverse events
Time Frame
12-week follow up.
Title
30-second chair-stand test
Description
To test leg strength and endurance of participants the 30-second chair-stand test will be performed at baseline and at the last day of follow-up.
Time Frame
12-week follow up.
Title
Tandem Test
Description
Balance will be evaluated with the Tandem Test at baseline and at the last day of follow-up.
Time Frame
12-week follow up.
Title
Ulcer size
Description
Ulcer size measurement is assessed on digital images with standardized measuring tape from participants last to the outpatient clinic visit prior to baseline and from participants last to the outpatient clinic visit to last day of follow-up. The measurement is a standard measurement in the outpatient clinic at every participant visit
Time Frame
12-week follow up.
Title
Wound-QoL
Description
Participants are asked to fill out the the Wound-QoL questionnaires in paper form at baseline and at the last day of follow-up
The Wound-QoL consists of 17 items that can be combined into three individual multi-item domains: Body, Psyche and Everyday life as well as a single-item domain on Economy
Time Frame
12-week follow up.
Title
EC-5D-5L
Description
Participants are asked to fill out the Danish versions of the patient-reported outcome measures (PROM) EQ-5D-5L in paper form at baseline and at the last day of follow-up.
The EQ-5D- 3L includes the European Quality of life visual analogue scale (EQ-VAS) where the patient's own health 'today' is rated between 0 (worst imaginable health) and 100 (best imaginable health)
Time Frame
12-week follow up.
Title
4x10-meter fast-paced walk test
Description
The 40 m FPWT is a test for performance on the activity short-distance walking. The test will be performed at baseline and at the last day of follow-up.
Time Frame
12-week follow up.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults aged 18 years or above
Diabetes mellitus
Non-surgical ulcer located distal to the malleoli
Willingness to participate in a 12-week supervised exercise therapy intervention twice a week
Prescribed with a therapeutic shoe, orthopaedic specialist shoe from the outpatient clinic or a specialized podiatrist.
Exclusion Criteria:
Dementia or other reasons that cause inability to give informed consent
People that are wheelchair-bound
People with a prescribed cast or walker boot
Unable to understand Danish.
Diagnosed with or awaiting evaluation of suspected acute phase Charcot arthropathy or osteomyelitis
Facility Information:
Facility Name
SUH Køge
City
Køge
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Exercise Therapy for People With a Diabetic Foot Ulcer - a Feasibility Study
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