Healing of neuropathic foot ulcers in adult patients with type 2 diabetes Skin and Connective Tissue Diseases
Conditions
Interventions
The very low calorie diet (VLCD) is known to be a safe and effective treatment for people with type 2 diabetes, particularly early on in the disease process. However, the impact or feasibility is not
Sponsors
Betsi Cadwaladr University Health Board
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Able to give written informed consent 2. Age 21 - 75 years 3. Type 2 diabetes (any duration and oral hyperglycaemic agents) with non-healing foot neuropathic foot ulcers (longer than 6 weeks duration) 4. Attending podiatry ulcer clinic in Wrexham Maelor Hospital 5. BMI >27 kg/m² and <45 kg/m²
Exclusion criteria
Exclusion criteria: 1. Significant arterial disease 2. Recent routine HbA1c >108 mmol/mol 3. Unintentional weight loss of > 5 kg in the last 6 months 4. Recent eGFR <30 ml/min/1.73 m² 5. Substance misuse 6. Undergoing active treatment for cancer 7. Myocardial infarction within the previous 6 months 8. Severe heart failure defined as equivalent to the New York Heart Association grade 3 (NYHA) 9. Learning difficulties 10. Current treatment with anti-obesity drugs 11. Diagnosed eating disorder or purging 12. Pregnant/considering pregnancy and/or breastfeeding 13. Patients who have required hospitalisation for depression (in the past 2 years) or are prescribed antipsychotic medication 14. People currently participating in another clinical research trial 15. Frailty (identified by The Canadian Study of Health and Aging Clinical Frailty Scale (CFS)) as defined by a frailty scale greater than 4 16. Prescribed Insulin for Diabetes management
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Patient wellbeing measured using the Warwick-Edinburgh Mental Well-being scale at baseline, week 9-12 and week 13 2. Hba1C (blood test) at baseline and week 13; weight and blood glucose at baseline and weekly until week 9, and weight at week 13 3. Weight and blood glucose measured using hospital or home scales (weight) and hospital or home glucose monitors (blood glucose) at baseline and weekly until week 9, and weight at week 13 | — |
Secondary
| Measure | Time frame |
|---|---|
| Wound healing at week 13 measured by reducing in size of the neuropathic foot ulcer | — |
Countries
United Kingdom
Contacts
Public ContactElaine;Elaine Jennings;Jennings
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Outcome results
None listed