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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01351493
Recruitment Status : Unknown
Verified July 2012 by China Medical University Hospital.
Recruitment status was:  Recruiting
First Posted : May 11, 2011
Last Update Posted : July 11, 2012
Information provided by (Responsible Party):
China Medical University Hospital

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

Condition or disease Intervention/treatment Phase
Pressure Ulcer Drug: Nitric Oxide Drug: placebo Phase 1 Phase 2

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Study on the Safety and Efficacy of Nitric Oxide Gel in Subjects With Pressure Sore
Study Start Date : July 2012
Estimated Primary Completion Date : July 2013
Estimated Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pressure Sores

Arm Intervention/treatment
Active Comparator: Nitric oxide gel Drug: Nitric Oxide
Nitric Oxide Gel, once or twice per day, 12weeks

Placebo Comparator: placebo Drug: placebo
placebo Gel, once or twice per day, 12weeks

Primary Outcome Measures :
  1. Pressure ulcer stage assessment after the endpoint of intervention period [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. The secondary efficacy end point will be pressure sore scale assessment of improvement. [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01351493

Contact: Chiu-Shong Liu, MD.MSc. 886-975681842

China Medical University Hospital Recruiting
Taichung, Taiwan, 404
Contact: Chih-Hsueh Lin, MD.Msc.    886-4-22052121 ext 4507   
Principal Investigator: Chih-Hsueh Lin, MD.MSc         
Sponsors and Collaborators
China Medical University Hospital
Principal Investigator: Chiu-Shong Liu, M.D. China Medical University Hospital

Responsible Party: China Medical University Hospital Identifier: NCT01351493     History of Changes
Other Study ID Numbers: DMR100-IRB-030
First Posted: May 11, 2011    Key Record Dates
Last Update Posted: July 11, 2012
Last Verified: July 2012

Keywords provided by China Medical University Hospital:
pressure sore
nitric oxide

Additional relevant MeSH terms:
Pressure Ulcer
Skin Ulcer
Skin Diseases
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Protective Agents