Phase 4
N=65
Pressure Ulcer Healing With Microcyn
Pressure Ulcer · Spinal Cord Injuries
Bottom Line
View on ClinicalTrials.gov: NCT02001558 ↗Enrolled (actual)
65
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcome: Primary: Pressure Ulcer Size (Length x Width x Depth, cm^3) at Baseline — 10.13; 21.00 cm^3
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Microcyn (Drug); Sterile saline (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Aug 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pressure Ulcer Size (Length x Width x Depth, cm^3) at Baseline |
10.13; 21.00 | — |
| PRIMARY Pressure Ulcer Size (Length x Width x Depth, cm^3) at 4 Weeks After Baseline |
9.00; 15.75 | — |
| PRIMARY Pressure Ulcer Size (Length x Width x Depth, cm^3) at 8 Weeks After Baseline |
10.00; 20.06 | — |
| PRIMARY Pressure Ulcer Size (Length x Width x Depth, cm^3) at 12 Weeks After Baseline |
7.50; 19.25 | — |
| PRIMARY Pressure Ulcer Size (Length x Width x Depth, cm^3) at 16 Weeks After Baseline |
8.00; 11.63 | — |
| PRIMARY Pressure Ulcer Size (Length x Width x Depth, cm^3) at 20 Weeks After Baseline |
7.63; 9.75 | — |
| PRIMARY Pressure Ulcer Size (Length x Width x Depth, cm^3) at 24 Weeks After Baseline |
3.68; 8.68 | — |
| SECONDARY Pressure Ulcer Scale for Healing (PUSH) Score |
12.00; 12.00 | — |
| SECONDARY Pressure Ulcer Scale for Healing (PUSH) Score at 4 Weeks After Baseline |
12.00; 11.00 | — |
| SECONDARY Pressure Ulcer Scale for Healing (PUSH) Score at 8 Weeks After Baseline |
11.00; 11.50 | — |
| SECONDARY Pressure Ulcer Scale for Healing (PUSH) Score at 12 Weeks After Baseline |
10.00; 11.50 | — |
| SECONDARY Pressure Ulcer Scale for Healing (PUSH) Score at 16 Weeks After Baseline |
12.00; 11.50 | — |
| SECONDARY Pressure Ulcer Scale for Healing (PUSH) Score at 20 Weeks After Baseline |
11.00; 10.50 | — |
| SECONDARY Pressure Ulcer Scale for Healing (PUSH) Score at 24 Weeks After Baseline |
10.50; 11.00 | — |
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
Data sourced from ClinicalTrials.gov (NCT02001558). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.