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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by China Medical University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
China Medical University Hospital
ClinicalTrials.gov Identifier:
NCT01351493
First received: May 9, 2011
Last updated: July 10, 2012
Last verified: July 2012
  Purpose

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


Condition Intervention Phase
Pressure Ulcer
Drug: Nitric Oxide
Drug: placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by China Medical University Hospital:

Primary Outcome Measures:
  • Pressure ulcer stage assessment after the endpoint of intervention period [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The secondary efficacy end point will be pressure sore scale assessment of improvement. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: July 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01351493

Contacts
Contact: Chiu-Shong Liu, MD.MSc. 886-975681842 liucs@ms14.hinet.net

Locations
Taiwan
China Medical University Hospital Recruiting
Taichung, Taiwan, 404
Contact: Chih-Hsueh Lin, MD.Msc.    886-4-22052121 ext 4507    d5496@mail.cmuh.org.tw   
Principal Investigator: Chih-Hsueh Lin, MD.MSc         
Sponsors and Collaborators
China Medical University Hospital
Investigators
Principal Investigator: Chiu-Shong Liu, M.D. China Medical University Hospital
  More Information

No publications provided

Responsible Party: China Medical University Hospital
ClinicalTrials.gov Identifier: NCT01351493     History of Changes
Other Study ID Numbers: DMR100-IRB-030
Study First Received: May 9, 2011
Last Updated: July 10, 2012
Health Authority: Taiwan: Department of Health

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

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

ClinicalTrials.gov processed this record on August 18, 2014