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Topical Hydromorphone for Wound Healing

Primary Purpose

Wound Healing

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

hydromorphone

About this trial

This is an interventional treatment trial for Wound Healing

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

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

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

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Topical Hydromorphone for Wound Healing

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