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

NCT05101473 | Completed

• 3 other identifiers: Exercise for DFUREG-075-2021SJ-928
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (11)

• 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.

Study Arms (1)

Exercise therapy

EXPERIMENTAL

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

Interventions

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.

Exercise therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Holbaek Sygehus: lead

Study Sites (1)

SUH Køge

Køge, Denmark

Location

MeSH Terms

Conditions

Diabetic Foot; Foot Ulcer

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 18, 2021
• First Posted: November 1, 2021
• Study Start: September 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: August 10, 2022

Record last verified: 2021-10

Locations

DK (1)