Study on the Safety and Efficacy of Nitric Oxide Gel in Subjects With Pressure Sore

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy of nitric oxide gel for pressure sore recovery.

Detailed Description
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Pressure sore is a common problem for patient with bed-ridden. The care of pressure sore cost many social and medical resource, and also effect the quality of life of patients. Current principles of treatment of pressure sore include adequate pain control, optimizing nutritional status, pressure relief, wound cleaning and dressing, infection control and surgical intervention if needed. Wound dressings should be based on wound characteristics. However, for improving wound healing, different dressing materials were developed. 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.

Official Title
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A Randomized, Double-blind, Placebo-controlled Study on the Safety and Efficacy of Nitric Oxide Gel in Subjects With Pressure Sore

Conditions
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Pressure Ulcer

Intervention / Treatment
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* Drug: Nitric Oxide
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who live in nursing home 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: diagnosis of cancer and still on active therapies 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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nitric oxide gel<br> | Drug: Nitric Oxide<br>* Nitric Oxide Gel, once or twice per day, 12weeks<br>|
| Placebo Comparator: placebo<br> | Drug: placebo<br>* placebo Gel, once or twice per day, 12weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pressure ulcer stage assessment after the endpoint of intervention period |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary efficacy end point will be pressure sore scale assessment of improvement. |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pressure sore, nitric oxide