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

Diabetic Foot Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05101473
• Other study ID #: Exercise for DFU
• Secondary ID: REG-075-2021SJ-9
• Status: Completed
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: April 1, 2022

Study information

• Verified date: October 2021
• Source: Holbaek Sygehus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: April 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer
• Ulcer Foot
• Ulcer Healing
• Wound Healing Disorder

Intervention

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.

Locations

Country	Name	City	State
Denmark	SUH Køge	Køge

Sponsors (1)

Lead Sponsor	Collaborator
Holbaek Sygehus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Participant retention	will be evaluated by the number of participants showing up at 12-week follow up.	12-week follow up.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	Tandem Test	Balance will be evaluated with the Tandem Test at baseline and at the last day of follow-up.	12-week follow up.
Primary	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.
Primary	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.
Primary	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.
Primary	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.