Pressure UlcerPhase 4NCT02001558

Pressure Ulcer Healing With Microcyn

A Phase 4 study testing Microcyn and Sterile saline in people with Pressure Ulcer and Spinal Cord Injuries, run by University of Alabama at Birmingham at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pressure Ulcer, Spinal Cord Injuries
What is being tested?: Microcyn and Sterile saline
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 65 participants
Where: 1 siteUnited States
Study dates: Mar 2013to Aug 2017
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Alabama at Birmingham
Birmingham, Alabama, 35249

Other trials in United States

About this study

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

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.

Conditions: Pressure Ulcer, Spinal Cord Injuries
Being tested: Microcyn, Sterile saline
Keywords: Spinal cord injuries, Pressure ulcer
Medical subject headings: Pressure Ulcer, Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MicrocynDrug
Also called Microcyn® Skin and Wound Care with preservatives
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
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

Study groups in NCT02001558
Study group	Role	What they receive
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. Receives: 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. Receives: Other: Sterile saline

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 weeks after baseline

Secondary outcomes (7)

Pressure Ulcer Scale for Healing (PUSH) Score
PUSH categorizes pressure ulcer by surface area, exudate, and type of wound tissue. A comparison of total scores measured over time provides an indication of the improvement or deterioration in pressure ulcer healing. Total score ranges from 0 (healed, normal) to 17 (most severe).
Measured: at baseline
Pressure Ulcer Scale for Healing (PUSH) Score at 4 Weeks After Baseline
PUSH categorizes pressure ulcer by surface area, exudate, and type of wound tissue. A comparison of total scores measured over time provides an indication of the improvement or deterioration in pressure ulcer healing. Total score ranges from 0 (healed, normal) to 17 (most severe).
Measured: 4 weeks after baseline
Pressure Ulcer Scale for Healing (PUSH) Score at 8 Weeks After Baseline
PUSH categorizes pressure ulcer by surface area, exudate, and type of wound tissue. A comparison of total scores measured over time provides an indication of the improvement or deterioration in pressure ulcer healing. Total score ranges from 0 (healed, normal) to 17 (most severe).
Measured: 8 weeks after baseline
Pressure Ulcer Scale for Healing (PUSH) Score at 12 Weeks After Baseline
PUSH categorizes pressure ulcer by surface area, exudate, and type of wound tissue. A comparison of total scores measured over time provides an indication of the improvement or deterioration in pressure ulcer healing. Total score ranges from 0 (healed, normal) to 17 (most severe).
Measured: 12 weeks after baseline
Pressure Ulcer Scale for Healing (PUSH) Score at 16 Weeks After Baseline
PUSH categorizes pressure ulcer by surface area, exudate, and type of wound tissue. A comparison of total scores measured over time provides an indication of the improvement or deterioration in pressure ulcer healing. Total score ranges from 0 (healed, normal) to 17 (most severe).
Measured: 16 weeks after baseline
Pressure Ulcer Scale for Healing (PUSH) Score at 20 Weeks After Baseline
PUSH categorizes pressure ulcer by surface area, exudate, and type of wound tissue. A comparison of total scores measured over time provides an indication of the improvement or deterioration in pressure ulcer healing. Total score ranges from 0 (healed, normal) to 17 (most severe).
Measured: 20 weeks after baseline
Pressure Ulcer Scale for Healing (PUSH) Score at 24 Weeks After Baseline
PUSH categorizes pressure ulcer by surface area, exudate, and type of wound tissue. A comparison of total scores measured over time provides an indication of the improvement or deterioration in pressure ulcer healing. Total score ranges from 0 (healed, normal) to 17 (most severe).
Measured: 24 weeks after baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2013Aug 2017

First posted5 Dec 2013 (estimated)
Study startMar 2013
Primary completionAug 2017
Study completionAug 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pressure UlcerStudies of the same condition, open and under way.
More trials run by University of Alabama at BirminghamThe 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 65 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02001558
Sponsor's protocol ID: MIC-UABWC-001
Status last verified: Oct 2018
First submitted: 18 Nov 2013
Last updated: 6 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
Clinical Trial Evaluating a Single Layer Amniotic Membrane and Standard of Care in the Management of Nonhealing Pressure Ulcers
Pressure Ulcer, Ulcer, Pressure
Not yet recruiting
Comparison of Negative Pressure Wound Therapy Versus Moist Wound Dressing in Diabetic Foot Ulcer Patients
Diabetic Foot Ulcer
Recruiting
Physical Therapy Wound Care Modalities in Patients With Spinal Cord Injury (SCI)
Spinal Cord Injuries, Pressure Injuries
Recruiting
Implementing a Decision Support Tool to Prevent Community-Acquired Pressure Injury in Spinal Cord Injury (SCI) in the Spinal Cord Injury Clinic
Spinal Cord Injury, Pressure Injury
Not yet recruitingObservational study
Explainable AI for Prospective Pressure Injury Staging
Pressure Injury

All Pressure Ulcer trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02001558
Acronym / sponsor ID: MIC-UABWC-001
Conditions: Pressure Ulcer, Spinal Cord Injuries
Keywords: Spinal cord injuries, Pressure ulcer
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 65 participants (actual)
Lead sponsor: University of Alabama at BirminghamUniversity, hospital or other
Collaborators: Oculus Innovative Sciences, Inc.
Study start: Mar 2013
Primary completion: Aug 2017 (actual)
Study completion: Aug 2017 (actual)
First posted: 5 Dec 2013 (estimated)
Results: Posted 6 Nov 2018

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 test how well Microcyn™ works on Stage 3 and Stage 4 pressure ulcers compared to sterile saline among persons with spinal cord injury.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Microcyn	Experimental	Drug: MicrocynMicrocyn 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.
Sterile saline	Active comparator	Other: Sterile salineSterile 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (6 listed)

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

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
MicrocynAlso: Microcyn® Skin and Wound Care with preservativesMicrocyn 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	Drug	Microcyn
Sterile salineSterile 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	Other	Sterile saline

Primary outcome

Pressure Ulcer Size (Length x Width x Depth, cm^3) at Baseline
Time frame: 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 4 Weeks After Baseline
Time frame: 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.
Pressure Ulcer Size (Length x Width x Depth, cm^3) at 8 Weeks After Baseline
Time frame: 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.
Pressure Ulcer Size (Length x Width x Depth, cm^3) at 12 Weeks After Baseline
Time frame: 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.
Pressure Ulcer Size (Length x Width x Depth, cm^3) at 16 Weeks After Baseline
Time frame: 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.
Pressure Ulcer Size (Length x Width x Depth, cm^3) at 20 Weeks After Baseline
Time frame: 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.
Pressure Ulcer Size (Length x Width x Depth, cm^3) at 24 Weeks After Baseline
Time frame: 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.

7 secondary outcomes

Pressure Ulcer Scale for Healing (PUSH) Score
Time frame: at baseline
Pressure Ulcer Scale for Healing (PUSH) Score at 4 Weeks After Baseline
Time frame: 4 weeks after baseline
Pressure Ulcer Scale for Healing (PUSH) Score at 8 Weeks After Baseline
Time frame: 8 weeks after baseline
Pressure Ulcer Scale for Healing (PUSH) Score at 12 Weeks After Baseline
Time frame: 12 weeks after baseline
Pressure Ulcer Scale for Healing (PUSH) Score at 16 Weeks After Baseline
Time frame: 16 weeks after baseline
Pressure Ulcer Scale for Healing (PUSH) Score at 20 Weeks After Baseline
Time frame: 20 weeks after baseline
Pressure Ulcer Scale for Healing (PUSH) Score at 24 Weeks After Baseline
Time frame: 24 weeks after baseline

Results and safety

Results posted to the registry on 6 Nov 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Microcyn	32	24
Sterile Saline	33	19

Primary outcome: Pressure Ulcer Size (Length x Width x Depth, cm^3) at Baseline

Time frame: pressure ulcer size (length x width x depth, cm^3) at baseline. Median (Full Range). Unit: cm^3

Measure	Microcyn n = 32	Sterile Saline n = 33
Value	10.13 (0.38 to 196.00)	21.00 (0.23 to 269.50)

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

Time frame: 4 weeks after baseline. Median (Full Range). Unit: cm^3

Measure	Microcyn n = 24	Sterile Saline n = 23
Value	9.00 (0.10 to 202.50)	15.75 (0.00 to 160.00)

Population analysed: Microcyn arm: there were 8 participants lost to follow up during this evaluation period. Sterile saline arm: there were 10 participants lost to follow up during this evaluation period.

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

Time frame: 8 weeks after baseline. Median (Full Range). Unit: cm^3

Measure	Microcyn n = 20	Sterile Saline n = 16
Value	10.00 (0.23 to 216.13)	20.06 (0.00 to 165.00)

Population analysed: Microcyn arm: there were 12 participants lost to follow up during this evaluation period. Sterile saline arm: there were 17 participants lost to follow up during this evaluation period.

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

Time frame: 12 weeks after baseline. Median (Full Range). Unit: cm^3

Measure	Microcyn n = 23	Sterile Saline n = 15
Value	7.50 (0.06 to 229.50)	19.25 (0.00 to 224.00)

Population analysed: Microcyn arm: there were 9 participants lost to follow up during this evaluation period. Sterile saline arm: there were 18 participants lost to follow up during this evaluation period.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: From baseline through 53 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Microcyn	0 of 32 (0%)	0 of 32 (0%)	0 of 32
Sterile Saline	0 of 33 (0%)	0 of 33 (0%)	0 of 33

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Pressure Ulcer

RecruitingPhase 4
Clinical Trial Evaluating a Single Layer Amniotic Membrane and Standard of Care in the Management of Nonhealing Pressure Ulcers
Pressure Ulcer, Ulcer, Pressure
Not yet recruiting
Comparison of Negative Pressure Wound Therapy Versus Moist Wound Dressing in Diabetic Foot Ulcer Patients
Diabetic Foot Ulcer
Recruiting
Physical Therapy Wound Care Modalities in Patients With Spinal Cord Injury (SCI)
Spinal Cord Injuries, Pressure Injuries
Recruiting
Implementing a Decision Support Tool to Prevent Community-Acquired Pressure Injury in Spinal Cord Injury (SCI) in the Spinal Cord Injury Clinic
Spinal Cord Injury, Pressure Injury
Not yet recruitingObservational study
Explainable AI for Prospective Pressure Injury Staging
Pressure Injury

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.

Yuying Chen, MD, PhD principal investigator

University of Alabama at Birmingham

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Microcyn and Sterile saline in people with Pressure Ulcer and Spinal Cord Injuries, run by University of Alabama at Birmingham at 1 site in United States.

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: finished, as of the sponsor's last update on 6 Nov 2018. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pressure Ulcer Size (Length x Width x Depth, cm^3) at Baseline (time frame: pressure ulcer size (length x width x depth, cm^3) at baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02001558.

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 6 Nov 2018.