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Randomised placebo controlled cross-over trial of topical opioids in the management of analgesia in leg ulcers

Randomised placebo controlled cross-over trial of topical opioids in the management of analgesia in leg ulcers

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN76288165
Enrollment
20
Registered
2003-09-12
Start date
2003-06-01
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Signs and Symptoms: Pain Skin and Connective Tissue Diseases Other disorders of skin and subcutaneous tissue, not elsewhere classified

Interventions

Prospective randomised controlled cross-over trial with questionnaire and interviews. Topical opioids versus placebo.

Sponsors

Department of Health (UK)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 20 Patients with chronic painful leg ulcers, from all inpatients at the Walsgrave Hospital (powered to give 75-80% preference rate of either active or placebo gel).

Exclusion criteria

Exclusion criteria: Does not match inclusion criteria

Design outcomes

Primary

MeasureTime frame
PRN (pro re nata - as needed) and regular analgesia requirement over preceding 24 h. Daily pain score and questionnaire regarding side-effects.

Secondary

MeasureTime frame
Not provided at time of registration

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026