Topical Hydromorphone for Wound Healing - Full Text View

Sponsored by:	Hordinsky, Maria K., MD
Information provided by:	University of Minnesota
ClinicalTrials.gov Identifier:	NCT00177060

Purpose

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

Condition	Intervention	Phase
Wound Healing	Drug: hydromorphone	Phase I Phase II

Drug Information available for: Hydromorphone Hydromorphone hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Placebo Control, Single Group Assignment, Efficacy Study
Official Title:	Topical Hydromorphone for Wound Healing

Further study details as provided by University of Minnesota:

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

Sponsors and Collaborators

Hordinsky, Maria K., MD

Investigators

Principal Investigator:	Maria Hordinsky, MD	University of Minnesota
Principal Investigator:	Robert Hebbel, MD	University of Minnesota

More Information

Study ID Numbers:	0308M50994
Study First Received:	September 13, 2005
Last Updated:	February 6, 2008
ClinicalTrials.gov Identifier:	NCT00177060
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Hydromorphone

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics

Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Pharmacologic Actions
Analgesics, Opioid

ClinicalTrials.gov processed this record on January 16, 2009