A Phase 1/2 interventional study of Nitric Oxide and placebo in Pressure Ulcer, sponsored by China Medical University Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-07-11.
Sponsored by China Medical University Hospital · Phase 1/2, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy of nitric oxide gel for pressure sore recovery.
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.
518 studies on the registry are indexed under Pressure Ulcer; 117 are open to participants now.
This study's planned enrollment of 40 is below the median of 70 across 395 interventional studies indexed under Pressure Ulcer.
Browse Pressure Ulcer studies →China Medical University Hospital is the lead sponsor of 464 studies on the registry; 116 are open to participants now.
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Exclusion Criteria:
Drug: Nitric Oxide
Drug: placebo
Nitric Oxide Gel, once or twice per day, 12weeks
placebo Gel, once or twice per day, 12weeks
Pressure ulcer stage assessment after the endpoint of intervention period
Time frame: 12 weeks
The secondary efficacy end point will be pressure sore scale assessment of improvement.
Time frame: 12 weeks
This study is status unknown, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.
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China Medical University Hospital