Painful venous leg ulcers MedDRA version: 9.1 Level: LLT Classification code 10066677 Term: Chronic leg ulcer
Conditions
Interventions
Trade Name: Morphine Sulphate Injection BP
Product Name: Morphine Sulphate Injection BP
Product Code: N/A
Pharmaceutical Form: Injection*
Pharmaceutical form of the placebo: Gel
Route of administratio
Sponsors
Aston University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients suffering from moist venous leg ulcers that are reported as painful. Patients able to give full informed caonsent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients with dry venous leg ulcers Patients unable to give full informed consent Patients with a history of allergy to an opioid analgesic. Patients taking MAOIs or other medication, which may interact with the topical Morphine. Patients unable or unwilling to go home without driving themselves. Patients who will be involved with machinery immediately after they have attended the clinic for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether 20mg of Morphine in 8g of topical gel demonstrates an analgesic effect on a painful venous leg ulcer. ;Secondary Objective: To assess the quality of life of those patients entered into the trial;Primary end point(s): Assessment of pain after one hour using a Visual Analogue (pain) Scale | — |
Countries
United Kingdom
Outcome results
None listed