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Topical Hydromorphone for Wound Healing

This study has been terminated.
(No funding available.)
Sponsor:
Information provided by:
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00177060
First received: September 13, 2005
Last updated: February 26, 2010
Last verified: February 2010
History of Changes
  Purpose

The hypothesis is that topical opioids will hasten wound healing in humans.


Condition Intervention Phase
Wound Healing
 Drug: hydromorphone
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Topical Hydromorphone for Wound Healing

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

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

Estimated Enrollment: 50
Study Start Date: October 2003
Study Completion Date: May 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Known bleeding disorder.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00177060     History of Changes
Other Study ID Numbers: 0308M50994
Study First Received: September 13, 2005
Last Updated: February 26, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hydromorphone
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on May 19, 2013