Patients with stage III/IV pressure ulcers.
Conditions
Interventions
Group x: receiving standard institutional diet + daily 3 x 200 ml of Cubitan between meals for a maximum period of 8 weeks.
Group y: receiving standard institutional diet + daily 3 x 200 ml non-calor
Sponsors
Numico Research B.V.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Stage III or IV pressure ulcers according to the European Pressure Ulcer Advisory Panel (EPUAP) classification system; 2. Stage III or IV pressure ulcers located on sacrum, greater trochanter, ischium or heel; 3. Age over 18 years and below 90 years; 4. Written informed consent from either patient or legal representative for patients who cannot consent themselves; 5. Use of standard institutional or regular diet without nutritional supplements during the last 2 weeks.
Exclusion criteria
Exclusion criteria: 1. Patients with severe medical conditions, e.g. ICU patients, patients with sepsis or serious infections, cancer patients requiring therapy, or patients after recent (< 3 months) myocardial infarction; 2. Patients with diabetes ulcers, ulcus cruris and/or vascular ulcer; 3. Life expectancy less than 6 months or hospice (palliative) care; 4. (Expected within 6 months) Nutrition via PEG (Percutaneous Endoscopic Gastrostomy) or PEJ (Percutaneous Endoscopic Jejunostomy) or nasogastric tube; 5. Drug or alcohol abuse in the opinion of investigator; 6. Patients prescribed medications that have an effect on pressure ulcer healing, e.g. hydroxyurea or chronic use of corticosteroids; 7. Protein-restricted diet due to renal insufficiency based on investigator’s judgement; 8. BMI <18.5 for patients between 18 and 70 years; BMI <21 for patients over 70 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the effect of Cubitan added to standard institutional diet with non-caloric placebo added to standard institutional diet on pressure ulcer size during 8 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the effect of Cubitan added to standard institutional diet with non-caloric placebo added to standard institutional diet on pressure Ulcer Scale for Healing (PUSH) tool score and photographic assessment during 8 weeks (reflecting pressure ulcer size, exudate amount and tissue type). | — |
Contacts
Public ContactRemko Hiemstra
Numico Research B.V. PO Box 7005
Outcome results
None listed