NCT00177060

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2003

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

March 1, 2010

Status Verified

February 1, 2010

First QC Date

September 13, 2005

Last Update Submit

February 26, 2010

Conditions

Wound Healing

Outcome Measures

Primary Outcomes (1)

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

Interventions

hydromorphoneDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Known bleeding disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Interventions

Hydromorphone

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Maria Hordinsky, MD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

  • Robert Hebbel, MD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDIV

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

October 1, 2003

Study Completion

May 1, 2007

Last Updated

March 1, 2010

Record last verified: 2010-02

Locations

US(1)