Topical Hydromorphone for Wound Healing

February 26, 2010 updated by: Hordinsky, Maria K., MD
The hypothesis is that topical opioids will hasten wound healing in humans.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This is based on our published data that morphine is a powerful stimulant of angiogenesis and our preclinical study of wounds in rats which demonstrate that topical opioids (morphine, hydromorphone and fentanyl) hasten healing of punch biopsy wounds. This study will focus on hydromorphone which was more powerful than morphine as a wound-healer in the rat study.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Self-identified as normal, healthy volunteers age 18-65.

Exclusion Criteria:

  • Known bleeding disorder.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Healing rates and microvessel density will be compared statistically for the control-ointment versus hydromorphone-ointment subjects.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hordinsky, Maria K., MD

Investigators

  • Principal Investigator: Robert Hebbel, MD, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

March 1, 2010

Last Update Submitted That Met QC Criteria

February 26, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0308M50994

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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