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

NCT ID: NCT05101473

Last Updated: 2022-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2022-04-01

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.

Conditions

Diabetic Foot Ulcer; Diabetic Foot; Wound Healing Disorder; Ulcer Foot; Ulcer Healing

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Exercise therapy

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

Group Type: EXPERIMENTAL

Exercise Therapy

Intervention Type: 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.

Interventions

Exercise Therapy

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Holbaek Sygehus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

SUH Køge

Køge, , Denmark

Countries

Denmark

Other Identifiers

REG-075-2021

Identifier Type: OTHER

Identifier Source: secondary_id

SJ-928

Identifier Type: OTHER

Identifier Source: secondary_id

Exercise for DFU

Identifier Type: -

Identifier Source: org_study_id