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CompletedNCT00007254Updated May 20, 2013

Morphine Gel for Bedsores

A Phase 1/2 interventional study of Pain relief for pressure ulcers in Decubitus Ulcer, sponsored by University of Kansas. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-05-20.

Sponsored by University of Kansas · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study tests the effectiveness of a morphine-containing gel for reducing pain caused by pressure ulcers, also known as bedsores or pressure sores. We will apply the gel containing morphine, or the gel alone, directly onto painful pressure ulcers and compare the results.

Read the detailed description

In this study, we will apply a morphine-containing gel (or placebo) directly onto painful pressure ulcers. We will take participants off of any opioid-containing medications upon entry into the study. This allows us to measure any morphine that may enter into the bloodstream from the topically applied gel.

The purpose of this study is to examine the efficacy of the gel for pressure ulcer analgesia, as well as the systemic absorption of morphine from the topically applied gel. We will document the amount of pain medications taken by participants to determine whether the gel decreases the need for these drugs.

02

Conditions studied

  • Decubitus Ulcer

Keywords

  • Analgesia
  • Bedsore
  • Morphine gel
  • Pressure ulcer
  • Pain
  • Ulcer
03

In context

Pressure Ulcer

517 studies on the registry are indexed under Pressure Ulcer; 116 are open to participants now.

This study's enrollment of 75 is close to the median of 70 across 394 interventional studies indexed under Pressure Ulcer.

Browse Pressure Ulcer studies →

Lead sponsor

University of Kansas is the lead sponsor of 81 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Presence of a Stage II pressure ulcer.
  • Pressure ulcer must be painful.
  • Primary Care physician must approve participation.
  • Thinking ability must be clear and intact.
  • Willing to change pain medication to oxycodone.

Exclusion criteria

Exclusion Criteria:

  • Allergy to morphine, oxycodone or intrasite gel.
  • Use of codeine- or morphine-containing medications.
  • Use of pain medications for anything other than the pressure ulcer.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
75 participants

Interventions

  • DrugPain relief for pressure ulcers
06

Study locations

2 sites
  • The University of Kansas Medical Center
    Kansas City, Kansas 66160, United States
  • Kindred Hospital
    Kansas City, Missouri, United States
07

References and documents

Publications

  • Twillman RK, Long TD, Cathers TA, Mueller DW. Treatment of painful skin ulcers with topical opioids. J Pain Symptom Manage. 1999 Apr;17(4):288-92. doi: 10.1016/s0885-3924(98)00140-7. PubMed 10203881 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 20, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00007254
Lead sponsor
University of Kansas
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted
Dec 18, 2000
Start date
Mar 2000
Completion
Feb 2003
Last update
May 20, 2013

Study contacts

Teresa D. Long, MD
principal investigator · The University of Kansas Medical Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.

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