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

NCT01351493 | Unknown Phase 1 DMC

• 1 other identifier: DMR100-IRB-030
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pressure Ulcer

Keywords

pressure sore; nitric oxide

Outcome Measures

Primary Outcomes (1)

• Pressure ulcer stage assessment after the endpoint of intervention period

  12 weeks

Secondary Outcomes (1)

• The secondary efficacy end point will be pressure sore scale assessment of improvement.

  12 weeks

Study Arms (2)

Nitric oxide gel

ACTIVE COMPARATOR

Drug: Nitric Oxide

placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

Nitric Oxide DRUG

Nitric Oxide Gel, once or twice per day, 12weeks

Nitric oxide gel

placebo DRUG

placebo Gel, once or twice per day, 12weeks

placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hospital

Taichung, Taichung, 404, Taiwan

RECRUITING

MeSH Terms

Conditions

Pressure Ulcer

Interventions

Nitric Oxide

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Reactive Nitrogen Species; Free Radicals; Inorganic Chemicals; Nitrogen Oxides; Nitrogen Compounds; Oxides; Oxygen Compounds; Organic Chemicals

Study Officials

• Chiu-Shong Liu, M.D.

  China Medical University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chiu-Shong Liu, MD.MSc.

CONTACT

886-975681842; liucs@ms14.hinet.net

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2011
• First Posted: May 11, 2011
• Study Start: July 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: July 11, 2012

Record last verified: 2012-07

Locations

TW (1)