Study on the Safety and Efficacy of Nitric Oxide Gel in Subjects With Pressure Sore
NCT ID: NCT01351493
Last Updated: 2012-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
40 participants
INTERVENTIONAL
2012-07-31
2013-07-31
Brief Summary
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Detailed Description
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There are increased evidences implicate nitric oxide (NO) synthesis plays an important role in the process of wound healing. Nitric oxide involve in angiogenesis, mediating inflammatory process, cell proliferation and collagen disposition, then improving wound healing. One study used topic NO-gel to mice with second degree burn wound, and found that the NO gel had the potential to enhance burn wound healing by regulation of many cellular processes in the skin. Based on the findings, the investigators hypothesize that NO gel could be used as an alternative method for pressure sore dressing to enhance wound healing.
This is a 12-week study. The investigators plan to enroll 40 subjects. The run-in period is set for screening based on inclusion and exclusion criteria. Baseline data including demographic profiles, medical history and current medications will be obtained, followed by an intact pressure sore inspection. Pressure ulcer stage (developed by NPAUP) , Pressure Ulcer Scale for Healing(PUSH) and Pressure Sore Status Tool(PSST) will be recorded before randomization. Baseline photograph of pressure sore will be taken .
During the treatment phase, a NO gel or placebo gel will be administered on the pressure sore wound by caregiver once or twice daily (decided by doctor according to clinical condition) after standard wound cleaning with normal saline. During the treatment period, the study subjects will be followed- up every 2 weeks to record the wound condition and any side effect. The investigators will use stage, PUSH and PSST, and take serial photograph to monitor wound condition.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Nitric oxide gel
Nitric Oxide
Nitric Oxide Gel, once or twice per day, 12weeks
placebo
placebo
placebo Gel, once or twice per day, 12weeks
Interventions
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Nitric Oxide
Nitric Oxide Gel, once or twice per day, 12weeks
placebo
placebo Gel, once or twice per day, 12weeks
Eligibility Criteria
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Inclusion Criteria
* Clinical diagnosis of pressure sore \> grade II(grade developed by NPAUP)
* without acute illness required hospitalization
* able to understanding and signed the Inform Consent Form after detailed description of the treatment and potential risks and benefits
Exclusion Criteria
* on other medications with pharmacological actions may lead to excessive formation of nitric oxide, or may accentuate drug effects due to excessive formation of nitric oxide
* with systemic infection and need systemic antibiotics
* pressure sore local infection and need topic antibiotic(for pressure sore wound)
* with any known allergic reaction to any ingredient in the 2 gel prescriptions
* Subjects who have been enrolled into any other clinical study in the preceding 3 months prior to randomization
40 Years
80 Years
ALL
No
Sponsors
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China Medical University Hospital
OTHER
Responsible Party
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Principal Investigators
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Chiu-Shong Liu, M.D.
Role: PRINCIPAL_INVESTIGATOR
China Medical University Hospital
Locations
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China Medical University Hospital
Taichung, Taichung, Taiwan
Countries
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Central Contacts
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Facility Contacts
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Chih-Hsueh Lin, MD.Msc.
Role: primary
Other Identifiers
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DMR100-IRB-030
Identifier Type: -
Identifier Source: org_study_id