Study on the Safety and Efficacy of Nitric Oxide Gel in Subjects With Pressure Sore
Recruitment status was: Recruiting
|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|
- Pressure ulcer stage assessment after the endpoint of intervention period [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
- The secondary efficacy end point will be pressure sore scale assessment of improvement. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
|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)|
|Active Comparator: Nitric oxide gel||
Drug: Nitric Oxide
Nitric Oxide Gel, once or twice per day, 12weeks
|Placebo Comparator: placebo||
placebo Gel, once or twice per day, 12weeks
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01351493
|China Medical University Hospital|
|Taichung, Taiwan, 404|
|Principal Investigator:||Chiu-Shong Liu, M.D.||China Medical University Hospital|