Topical Hydromorphone for Wound Healing

Wound Healing Clinical Trial

Official title:

Topical Hydromorphone for Wound Healing

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00177060
• Other study ID #: 0308M50994
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: September 13, 2005
• Last updated: February 26, 2010
• Start date: October 2003
• Est. completion date: May 2007

Study information

• Verified date: February 2010
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: May 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Known bleeding disorder.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Wound Healing

Intervention

Drug:
• hydromorphone

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Hordinsky, Maria K., MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healing rates and microvessel density will be compared statistically for the control-ointment versus hydromorphone-ointment subjects.