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Topical Hydromorphone for Wound Healing

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ClinicalTrials.gov Identifier: NCT00177060
Recruitment Status : Terminated (No funding available.)
First Posted : September 15, 2005
Last Update Posted : March 1, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
The hypothesis is that topical opioids will hasten wound healing in humans.

Condition or disease Intervention/treatment Phase
Wound Healing Drug: hydromorphone Phase 1 Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Topical Hydromorphone for Wound Healing
Study Start Date : October 2003
Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Healing rates and microvessel density will be compared statistically for the control-ointment versus hydromorphone-ointment subjects.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Known bleeding disorder.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00177060


Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
Hordinsky, Maria K., MD
Investigators
Principal Investigator: Maria Hordinsky, MD University of Minnesota - Clinical and Translational Science Institute
Principal Investigator: Robert Hebbel, MD University of Minnesota - Clinical and Translational Science Institute
More Information

ClinicalTrials.gov Identifier: NCT00177060     History of Changes
Other Study ID Numbers: 0308M50994
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: March 1, 2010
Last Verified: February 2010

Additional relevant MeSH terms:
Wounds and Injuries
Hydromorphone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents