NCT02001558

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2013

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2013

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 5, 2013

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

November 6, 2018

Completed
Last Updated

November 6, 2018

Status Verified

October 1, 2018

Enrollment Period

4.4 years

First QC Date

November 18, 2013

Results QC Date

August 28, 2018

Last Update Submit

October 8, 2018

Conditions

Pressure UlcerSpinal Cord Injuries

Keywords

Spinal cord injuriesPressure ulcer

Outcome Measures

Primary Outcomes (7)

  • Pressure Ulcer Size (Length x Width x Depth, cm^3) at Baseline

    Pressure ulcer size is measured after debridement if debridement is provided. The pressure ulcer size (cubic centimeter) is the length (centimeter) times the width (centimeter) times the depth(centimeter). The range of value is from 0 to positive infinite.

    pressure ulcer size (length x width x depth, cm^3) at baseline

  • Pressure Ulcer Size (Length x Width x Depth, cm^3) at 4 Weeks After Baseline

    Pressure ulcer size is measured after debridement if debridement is provided. The pressure ulcer size (cubic centimeter) is the length (centimeter) times the width (centimeter) times the depth(centimeter). The range of value is from 0 to positive infinite.

    4 weeks after baseline

  • Pressure Ulcer Size (Length x Width x Depth, cm^3) at 8 Weeks After Baseline

    Pressure ulcer size is measured after debridement if debridement is provided. The pressure ulcer size (cubic centimeter) is the length (centimeter) times the width (centimeter) times the depth(centimeter). The range of value is from 0 to positive infinite.

    8 weeks after baseline

  • Pressure Ulcer Size (Length x Width x Depth, cm^3) at 12 Weeks After Baseline

    Pressure ulcer size is measured after debridement if debridement is provided. The pressure ulcer size (cubic centimeter) is the length (centimeter) times the width (centimeter) times the depth(centimeter). The range of value is from 0 to positive infinite.

    12 weeks after baseline

  • Pressure Ulcer Size (Length x Width x Depth, cm^3) at 16 Weeks After Baseline

    Pressure ulcer size is measured after debridement if debridement is provided. The pressure ulcer size (cubic centimeter) is the length (centimeter) times the width (centimeter) times the depth(centimeter). The range of value is from 0 to positive infinite.

    16 weeks after baseline

  • Pressure Ulcer Size (Length x Width x Depth, cm^3) at 20 Weeks After Baseline

    Pressure ulcer size is measured after debridement if debridement is provided. The pressure ulcer size (cubic centimeter) is the length (centimeter) times the width (centimeter) times the depth(centimeter). The range of value is from 0 to positive infinite.

    20 weeks after baseline

  • Pressure Ulcer Size (Length x Width x Depth, cm^3) at 24 Weeks After Baseline

    Pressure ulcer size is measured after debridement if debridement is provided. The pressure ulcer size (cubic centimeter) is the length (centimeter) times the width (centimeter) times the depth(centimeter). The range of value is from 0 to positive infinite.

    24 weeks after baseline

Secondary Outcomes (7)

  • Pressure Ulcer Scale for Healing (PUSH) Score

    at baseline

  • Pressure Ulcer Scale for Healing (PUSH) Score at 4 Weeks After Baseline

    4 weeks after baseline

  • Pressure Ulcer Scale for Healing (PUSH) Score at 8 Weeks After Baseline

    8 weeks after baseline

  • Pressure Ulcer Scale for Healing (PUSH) Score at 12 Weeks After Baseline

    12 weeks after baseline

  • Pressure Ulcer Scale for Healing (PUSH) Score at 16 Weeks After Baseline

    16 weeks after baseline

  • +2 more secondary outcomes

Study Arms (2)

Microcyn

EXPERIMENTAL

Microcyn is liberally sprayed on wound and permitted to remain on wound which will then be dressed with gauze that is moistened with Microcyn twice daily.

Drug: Microcyn

Sterile saline

ACTIVE COMPARATOR

Sterile saline is liberally sprayed on wound and permitted to remain on wound which will then be dressed with gauze that is moistened with sterile saline twice daily.

Other: Sterile saline

Interventions

MicrocynDRUG

Microcyn is liberally sprayed on wound and permitted to remain on wound which will then be dressed with gauze that is moistened with Microcyn twice daily for the earlier of total wound closure or Week 24

Also known as: Microcyn® Skin and Wound Care with preservatives
Microcyn
Sterile salineOTHER

Sterile saline is liberally sprayed on wound and permitted to remain on wound which will then be dressed with gauze that is moistened with sterile saline twice daily for the earlier of total wound closure or Week 24

Sterile saline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Location

MeSH Terms

Conditions

Pressure UlcerSpinal Cord Injuries

Interventions

Preservatives, Pharmaceutical

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue DiseasesSpinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Pharmaceutic AidsPharmaceutical PreparationsSpecialty Uses of ChemicalsChemical Actions and Uses

Results Point of Contact

Title
Yuying Chen, MD, PhD
Organization
University of Alabama at Birmingham
yuyingchen@uabmc.edu
205-934-3329

Study Officials

  • Yuying Chen, MD, PhD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 18, 2013

First Posted

December 5, 2013

Study Start

March 1, 2013

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

November 6, 2018

Results First Posted

November 6, 2018

Record last verified: 2018-10

Locations

US(1)