Pressure UlcerPhase 1/2NCT01351493
Study on the Safety and Efficacy of Nitric Oxide Gel in Subjects With Pressure Sore
A Phase 1/2 study testing Nitric Oxide in people with Pressure Ulcer, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to evaluate the efficacy of nitric oxide gel for pressure sore recovery. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Pressure Ulcer
- What is being tested?
- Nitric Oxide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2012to Jul 2013
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University Hospital
Taichung, Taichung, 404
Chih-Hsueh Lin, MD.Msc., 886-4-22052121 ext. 4507, d5496@mail.cmuh.org.tw
Chih-Hsueh Lin, MD.MSc
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study on the Safety and Efficacy of Nitric Oxide Gel in Subjects With Pressure Sore
The purpose of this study is to evaluate the efficacy of nitric oxide gel for pressure sore recovery.
Read the 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.
- Conditions
- Pressure Ulcer
- Being tested
- Nitric Oxide, placebo
- Keywords
- pressure sore, nitric oxide
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitric OxideDrug
Nitric Oxide Gel, once or twice per day, 12weeks
placeboDrug
placebo Gel, once or twice per day, 12weeks
| Study group | Role | What they receive |
|---|---|---|
| Nitric oxide gel | Active comparator | Not described Receives: Drug: Nitric Oxide |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure ulcer stage assessment after the endpoint of intervention period
Measured: 12 weeks
Secondary outcomes (1)
The secondary efficacy end point will be pressure sore scale assessment of improvement.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2011 (estimated)
- Study startJul 2012
- Primary completionJul 2013 (estimated)
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure UlcerStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chiu-Shong Liu, M.D., Principal investigator, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01351493
- Sponsor's protocol ID
- DMR100-IRB-030
- Status last verified
- Jul 2012
- First submitted
- 9 May 2011
- Last updated
- 11 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study on the Safety and Efficacy of Nitric Oxide Gel in Subjects With Pressure Sore
- ClinicalTrials.gov ID
- NCT01351493
- Acronym / sponsor ID
- DMR100-IRB-030
- Conditions
- Pressure Ulcer
- Keywords
- pressure sore, nitric oxide
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 11 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy of nitric oxide gel for pressure sore recovery.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nitric oxide gel | Active comparator | Drug: Nitric Oxide |
| placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nitric OxideNitric Oxide Gel, once or twice per day, 12weeks | Drug | Nitric oxide gel |
| placeboplacebo Gel, once or twice per day, 12weeks | Drug | placebo |
Primary outcome
Pressure ulcer stage assessment after the endpoint of intervention period
Time frame: 12 weeks
1 secondary outcome
The secondary efficacy end point will be pressure sore scale assessment of improvement.
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chiu-Shong Liu, M.D. principal investigator
China Medical University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Nitric Oxide in people with Pressure Ulcer, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chiu-Shong Liu, MD.MSc. (886-975681842, liucs@ms14.hinet.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure ulcer stage assessment after the endpoint of intervention period (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2012.