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.

Study Overview

• Status: Completed
• Conditions: Diabetic Foot; Diabetic Foot Ulcer; Ulcer Foot; Ulcer Healing; Wound Healing Disorder
• Intervention / Treatment: Other: Exercise Therapy

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Køge, Denmark
    • SUH Køge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise therapy; 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; 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.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Holbaek Sygehus

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): April 1, 2022
• Study Completion (Actual): April 1, 2022

Study Registration Dates

• First Submitted: October 18, 2021
• First Submitted That Met QC Criteria: October 29, 2021
• First Posted (Actual): November 1, 2021

Study Record Updates

• Last Update Posted (Actual): August 10, 2022
• Last Update Submitted That Met QC Criteria: August 9, 2022
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer
• Other Study ID Numbers: Exercise for DFU; REG-075-2021 (Other Identifier: Datatilsynet); SJ-928 (Other Identifier: Videnskabsetisk Komite)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No