Diabetic foot ulcer Nutritional, Metabolic, Endocrine
Conditions
Interventions
The study will recruit 60 patients with active diabetic foot ulceration. Individuals that register their interest in the study (providing they have read the participant information sheet) will be book
Sponsors
University of Leicester
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 03/05/2023: 1. Actively receiving or has received DFU treatment within the previous 12 months 2. Aged > = 18 years of age 3. Able to undertake upper body arm exercise (specifically arm ergometry) 4. Deemed safe to exercise further to cardiac nurse evaluation at baseline 5. Participant is willing to give informed consent to take part in the study Previous inclusion criteria: 1. Actively receiving DFU treatment 2. > = 18 to < = 75 years of age 3. Able to undertake upper body arm exercise (specifically arm ergometry) 4. Deemed safe to exercise further to cardiac nurse evaluation at baseline 5. Participant is willing to give informed consent to take part in the study
Exclusion criteria
Exclusion criteria: 1. Uncontrolled hyperglycaemia (HbA1c > 10% - Confirmed through baseline blood sample results) 2. Report taking part in regular (at least once a week) strenuous sport or activities 3. Under weight or with a Body Mass Index of < = 18.5 kg/m2 4. Existing heart problem (a cardiovascular event within the last 12 months or screened by cardiac nurse at baseline) 5. Co-morbidity that the research team consider to be a contraindication to their study involvement 6. Unable to communicate in written or verbal English 7. Unable to provide written informed consent * In the circumstance that an individual is not sure whether they meet the necessary criteria, they will be reviewed by a medic (named on the delegation log) for a clinical decision to be made during their baseline visit (prior to engaging in any study-related tasks)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cardio-respiratory fitness measured via a maximal incremental exercise test and quantified by the maximal amount of oxygen consumed and utilised (VO2 peak) pre and post the 12-week intervention (baseline and follow-up) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Cardio-metabolic health assessed by a venous blood sample analysed for HbA1c, glucose, insulin and blood lipids (total cholesterol, high-density lipoprotein cholesterol, non-esterified fatty acids and triglycerides). These will be taken from venous blood while under fasting conditions both pre and post the 12-week intervention (baseline and follow-up). Also measured at these two timepoints will be blood pressure. 2. Quality of life assessed through a number of health-related quality of life questionnaires (Cardiff Wound Impact Schedule, The 36-Item Short Form Health Survey questionnaire, The EQ5D-5L instrument, The Hospital Anxiety and Depression scale and The Diabetes Distress Scale -17) pre and post the 12-week intervention period 3. Physical function assessed pre and post the 12 week intervention period: 3.1. Lower body physical function assessed by the Short Physical Performance Battery (SPPB) which assesses balance, walking speed and ability to sit and stand to and from a chair. Handgrip strength will be determined using digital handheld dynamometer 3.2. Upper body strength assessed via a 30-second arm curl test. This test involves lifting a dumbbell (5 lbs for women and 8 lbs for men) as many times in 30 seconds as possible and forms part of the ‘Senior Fitness Test’ performance battery 3.3. The effect of breathlessness on daily activities, assessed using the MRC breathlessness scale 4. Body composition assessed with dual-energy X-ray absorptiometry (DEXA) scanning which will derive a breakdown of; body fat, muscle mass and bone density. Bodyweight, height, waist circumference and arm circumference will be also measured pre and post the 12-week intervention period (baseline and follow-up) 5. Cross-sectional area of the foot ulcer determined by an acetate grid tracing method undertaken both pre and post the 12-week intervention period (baseline and follow-up) | — |
Countries
England, United Kingdom
Outcome results
None listed