Topical Hydromorphone for Wound Healing
This study has been terminated.
(No funding available.)
Sponsor:
Hordinsky, Maria K., MD
Information provided by:
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00177060
First received: September 13, 2005
Last updated: February 26, 2010
Last verified: February 2010
| Tracking Information | |||||||||
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| First Received Date ICMJE | September 13, 2005 | ||||||||
| Last Updated Date | February 26, 2010 | ||||||||
| Start Date ICMJE | October 2003 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE |
Healing rates and microvessel density will be compared statistically for the control-ointment versus hydromorphone-ointment subjects. | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00177060 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Current Other Outcome Measures ICMJE | |||||||||
| Original Other Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Topical Hydromorphone for Wound Healing | ||||||||
| Official Title ICMJE | Topical Hydromorphone for Wound Healing | ||||||||
| Brief Summary | The hypothesis is that topical opioids will hasten wound healing in humans. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 1 Phase 2 |
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| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind Primary Purpose: Treatment |
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| Condition ICMJE | Wound Healing | ||||||||
| Intervention ICMJE | Drug: hydromorphone | ||||||||
| Study Arm (s) | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Terminated | ||||||||
| Estimated Enrollment ICMJE | 50 | ||||||||
| Completion Date | May 2007 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 65 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00177060 | ||||||||
| Other Study ID Numbers ICMJE | 0308M50994 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | |||||||||
| Study Sponsor ICMJE | Hordinsky, Maria K., MD | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | University of Minnesota - Clinical and Translational Science Institute | ||||||||
| Verification Date | February 2010 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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