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

Holbaek Sygehus

Status: Completed

Conditions: Wound Healing Disorder; Diabetic Foot; Ulcer Healing; Diabetic Foot Ulcer; Ulcer Foot

Treatments: Other: Exercise Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05101473

Exercise for DFU

SJ-928 (Other Identifier)

REG-075-2021 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Exercise therapy

Experimental group

Description:

Exercises will be performed with minimal weight bearing on foot soles, as recommended in the literature for people with diabetic peripheral neuropathy.

Treatment:

Other: Exercise Therapy