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

Pressure Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01351493
• Other study ID #: DMR100-IRB-030
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: May 9, 2011
• Last updated: July 10, 2012
• Start date: July 2012
• Est. completion date: July 2013

Study information

• Verified date: July 2012
• Source: China Medical University Hospital
• Contact: Chiu-Shong Liu, MD.MSc.
• Phone: 886-975681842
• Email: liucs[@]ms14.hinet.net
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pressure Ulcer

Intervention

Drug:
• Nitric Oxide
Nitric Oxide Gel, once or twice per day, 12weeks
• placebo
placebo Gel, once or twice per day, 12weeks

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pressure ulcer stage assessment after the endpoint of intervention period		12 weeks	Yes
Secondary	The secondary efficacy end point will be pressure sore scale assessment of improvement.		12 weeks	Yes