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Completed

NCT Number: NCT05101473

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

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.

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Key information

Conditions

Diabetic Foot Ulcer Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Diseases Foot Ulcer Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Ulcer Foot Ulcer Healing Vascular Diseases Wound Healing Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SUH Køge

Køge, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise therapy

Other

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 outcomes

  1. Recruitment rate

    Time frame: 6 month

    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).

  2. Participant retention

    Time frame: 12-week follow up.

    will be evaluated by the number of participants showing up at 12-week follow up.

  3. Exercise adherence

    Time frame: 12-week follow up.

    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.

  4. Adverse events

    Time frame: 12-week follow up.

    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

  5. Participant and physiotherapist feedback

    Time frame: 12-week follow up.

    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

  6. 30-second chair-stand test

    Time frame: 12-week follow up.

    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.

  7. Tandem Test

    Time frame: 12-week follow up.

    Balance will be evaluated with the Tandem Test at baseline and at the last day of follow-up.

  8. Ulcer size

    Time frame: 12-week follow up.

    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

  9. Wound-QoL

    Time frame: 12-week follow up.

    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

  10. EC-5D-5L

    Time frame: 12-week follow up.

    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)

  11. 4x10-meter fast-paced walk test

    Time frame: 12-week follow up.

    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.

Sponsors and collaborators

Lead sponsor

Holbaek Sygehus

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 1, 2021
Registry last updated
Aug 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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