Clinical trial NCT02001558: Pressure Ulcer Healing With Microcyn
Official title: A Six Month Randomized Open-Label Trial of Pressure Ulcer Healing With Microcyn® Skin and Wound Care With Preservatives Versus Sterile Saline in Adult Spinal Cord Injury Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pressure Ulcer
Spinal Cord Injuries
Keywords: Spinal cord injuries
Pressure ulcer
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Oculus Innovative Sciences, Inc.
First posted: 2013-12-05
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test how well Microcyn™ works on Stage 3 and Stage 4 pressure ulcers compared to sterile saline among persons with spinal cord injury.


Eligibility criteria: Inclusion Criteria:

* Age \> 17 years
* Persons with spinal cord injury
* Having Stage III/IV pressure ulcer(s)
* Able to fulfill all obligations of the study

Exclusion Criteria:

* Pressure ulcers scheduled for surgical closure within 14 days
* Use of any immunosuppressant medications within 30 days of screening
* Having conditions that put the subject at significant risk
* Medically unstable or has a life expectancy of less than 12 months
* Current enrollment in an investigational drug or device study or participation in such a study within the last 30 days
* Pregnant women

Primary outcomes:
measure: Pressure Ulcer Size (Length x Width x Depth, cm^3) at Baseline
timeFrame: pressure ulcer size (length x width x depth, cm^3) at baseline
measure: Pressure Ulcer Size (Length x Width x Depth, cm^3) at 4 Weeks After Baseline
timeFrame: 4 weeks after baseline
measure: Pressure Ulcer Size (Length x Width x Depth, cm^3) at 8 Weeks After Baseline
timeFrame: 8 weeks after baseline
measure: Pressure Ulcer Size (Length x Width x Depth, cm^3) at 12 Weeks After Baseline
timeFrame: 12 weeks after baseline
measure: Pressure Ulcer Size (Length x Width x Depth, cm^3) at 16 Weeks After Baseline
timeFrame: 16 weeks after baseline
measure: Pressure Ulcer Size (Length x Width x Depth, cm^3) at 20 Weeks After Baseline
timeFrame: 20 weeks after baseline
measure: Pressure Ulcer Size (Length x Width x Depth, cm^3) at 24 Weeks After Baseline
timeFrame: 24 weeks after baseline
Secondary outcomes:
measure: Pressure Ulcer Scale for Healing (PUSH) Score
timeFrame: at baseline
measure: Pressure Ulcer Scale for Healing (PUSH) Score at 4 Weeks After Baseline
timeFrame: 4 weeks after baseline
measure: Pressure Ulcer Scale for Healing (PUSH) Score at 8 Weeks After Baseline
timeFrame: 8 weeks after baseline
measure: Pressure Ulcer Scale for Healing (PUSH) Score at 12 Weeks After Baseline
timeFrame: 12 weeks after baseline
measure: Pressure Ulcer Scale for Healing (PUSH) Score at 16 Weeks After Baseline
timeFrame: 16 weeks after baseline
measure: Pressure Ulcer Scale for Healing (PUSH) Score at 20 Weeks After Baseline
timeFrame: 20 weeks after baseline
measure: Pressure Ulcer Scale for Healing (PUSH) Score at 24 Weeks After Baseline
timeFrame: 24 weeks after baseline
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Yuying Chen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: