Topical Hydromorphone for Wound Healing
Primary Purpose
Wound Healing
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
hydromorphone
Sponsored by
About this trial
This is an interventional treatment trial for Wound Healing
Eligibility Criteria
Inclusion Criteria: Self-identified as normal, healthy volunteers age 18-65. Exclusion Criteria: Known bleeding disorder.
Sites / Locations
- University of Minnesota
Outcomes
Primary Outcome Measures
Healing rates and microvessel density will be compared statistically for the control-ointment versus hydromorphone-ointment subjects.
Secondary Outcome Measures
Full Information
NCT ID
NCT00177060
First Posted
September 13, 2005
Last Updated
February 26, 2010
Sponsor
Hordinsky, Maria K., MD
1. Study Identification
Unique Protocol Identification Number
NCT00177060
Brief Title
Topical Hydromorphone for Wound Healing
Official Title
Topical Hydromorphone for Wound Healing
Study Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Terminated
Why Stopped
No funding available.
Study Start Date
October 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hordinsky, Maria K., MD
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The hypothesis is that topical opioids will hasten wound healing in humans.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Healing
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
hydromorphone
Primary Outcome Measure Information:
Title
Healing rates and microvessel density will be compared statistically for the control-ointment versus hydromorphone-ointment subjects.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Self-identified as normal, healthy volunteers age 18-65.
Exclusion Criteria:
Known bleeding disorder.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Hordinsky, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert Hebbel, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Topical Hydromorphone for Wound Healing
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