Exercise Therapy for People With a Diabetic Foot Ulcer - a Feasibility Study

Study Overview
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Brief Summary
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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.

Official Title
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Exercise Therapy for People With a Diabetic Foot Ulcer - a Feasibility Study

Conditions
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Diabetic Foot Ulcer, Diabetic Foot, Wound Healing Disorder, Ulcer Foot, Ulcer Healing

Intervention / Treatment
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* Other: Exercise Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise therapy<br>Exercises will be performed with minimal weight bearing on foot soles, as recommended in the literature for people with diabetic peripheral neuropathy. | Other: Exercise Therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 6 month | 
| Participant retention | will be evaluated by the number of participants showing up at 12-week follow up. | 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. | 12-week follow up. | 
| 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 | 12-week follow up. | 
| 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 | 12-week follow up. | 
| 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. | 12-week follow up. | 
| Tandem Test | Balance will be evaluated with the Tandem Test at baseline and at the last day of follow-up. | 12-week 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 | 12-week follow up. | 
| 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 | 12-week follow up. | 
| 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) | 12-week follow up. | 
| 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. | 12-week follow up. |