Trial Outcomes & Findings for Developing Strategies for Effective Debridement in Patients for Venous Leg Ulcers (NCT NCT03796793)
NCT ID: NCT03796793
Last Updated: 2026-05-14
Results Overview
RNA sequencing will be used to determine the number of differentially expressed genes of the intervention group in samples collected pre-debridement to samples collected post-debridement.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
41 participants
Primary outcome timeframe
Baseline and 4 weeks
Results posted on
2026-05-14
Participant Flow
Participant milestones
| Measure |
Wound Edge Debridement Group
Participants in this group will receive wound edge debridement in addition to standard of care (SOC) treatment for up to 4 weeks.
Wound Edge Debridement: Wound debridement is performed using a sharp, circular disposable curette to remove the slough, non-viable tissue and any fibrous tissue down to the vascular base.
Standard of Care Treatment: Standard of Care treatment will include foam dressing and 4 layer compression therapy, changed weekly.
|
Standard Care Group
Participants in this group will receive only the standard care of treatment for up to 4 weeks.
Standard of Care Treatment: Standard of Care treatment will include foam dressing and 4 layer compression therapy, changed weekly.
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
14
|
|
Overall Study
COMPLETED
|
24
|
14
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
Wound Edge Debridement Group
Participants in this group will receive wound edge debridement in addition to standard of care (SOC) treatment for up to 4 weeks.
Wound Edge Debridement: Wound debridement is performed using a sharp, circular disposable curette to remove the slough, non-viable tissue and any fibrous tissue down to the vascular base.
Standard of Care Treatment: Standard of Care treatment will include foam dressing and 4 layer compression therapy, changed weekly.
|
Standard Care Group
Participants in this group will receive only the standard care of treatment for up to 4 weeks.
Standard of Care Treatment: Standard of Care treatment will include foam dressing and 4 layer compression therapy, changed weekly.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Developing Strategies for Effective Debridement in Patients for Venous Leg Ulcers
Baseline characteristics by cohort
| Measure |
Wound Edge Debridement Group
n=27 Participants
Participants in this group will receive wound edge debridement in addition to standard of care (SOC) treatment for up to 4 weeks.
Wound Edge Debridement: Wound debridement is performed using a sharp, circular disposable curette to remove the slough, non-viable tissue and any fibrous tissue down to the vascular base.
Standard of Care Treatment: Standard of Care treatment will include foam dressing and 4 layer compression therapy, changed weekly.
|
Standard Care Group
n=14 Participants
Participants in this group will receive only the standard care of treatment for up to 4 weeks.
Standard of Care Treatment: Standard of Care treatment will include foam dressing and 4 layer compression therapy, changed weekly.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.7 years
STANDARD_DEVIATION 13.5 • n=1512 Participants
|
64.3 years
STANDARD_DEVIATION 11.8 • n=504 Participants
|
61.3 years
STANDARD_DEVIATION 13. • n=2016 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=1512 Participants
|
4 Participants
n=504 Participants
|
16 Participants
n=2016 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=1512 Participants
|
10 Participants
n=504 Participants
|
25 Participants
n=2016 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=1512 Participants
|
3 Participants
n=504 Participants
|
5 Participants
n=2016 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=1512 Participants
|
11 Participants
n=504 Participants
|
36 Participants
n=2016 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
1 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Black or African American
|
21 Participants
n=1512 Participants
|
10 Participants
n=504 Participants
|
31 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=1512 Participants
|
3 Participants
n=504 Participants
|
8 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=1512 Participants
|
1 Participants
n=504 Participants
|
1 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=1512 Participants
|
14 participants
n=504 Participants
|
41 participants
n=2016 Participants
|
PRIMARY outcome
Timeframe: Baseline and 4 weeksPopulation: Change in Differentially Expressed Genes (DEGs) from pre-deberidment to post-debridement samples in the "wound edge debridement" group.
RNA sequencing will be used to determine the number of differentially expressed genes of the intervention group in samples collected pre-debridement to samples collected post-debridement.
Outcome measures
| Measure |
Wound Edge Debridement Group
n=24 Participants
Participants in this group will receive wound edge debridement in addition to standard of care (SOC) treatment for up to 4 weeks.
Wound Edge Debridement: Wound debridement is performed using a sharp, circular disposable curette to remove the slough, non-viable tissue and any fibrous tissue down to the vascular base.
Standard of Care Treatment: Standard of Care treatment will include foam dressing and 4 layer compression therapy, changed weekly.
|
Standard Care Group
Participants in this group will receive only the standard care of treatment for up to 4 weeks.
Standard of Care Treatment: Standard of Care treatment will include foam dressing and 4 layer compression therapy, changed weekly.
|
|---|---|---|
|
Change in the Genetic Profile After Debridement in the Intervention Group.
|
1031 Number of Differentially Expressed Genes
|
—
|
SECONDARY outcome
Timeframe: Baseline to 4 weeksWound size is measured at every weekly visit. If the wound size decreased by 50% from baseline to week 4, the participant in considered having a "healing wound". If the wound size does not decreased by 50% from baseline to week 4, the participant is considered a "non-healing wound".
Outcome measures
| Measure |
Wound Edge Debridement Group
n=24 Participants
Participants in this group will receive wound edge debridement in addition to standard of care (SOC) treatment for up to 4 weeks.
Wound Edge Debridement: Wound debridement is performed using a sharp, circular disposable curette to remove the slough, non-viable tissue and any fibrous tissue down to the vascular base.
Standard of Care Treatment: Standard of Care treatment will include foam dressing and 4 layer compression therapy, changed weekly.
|
Standard Care Group
n=14 Participants
Participants in this group will receive only the standard care of treatment for up to 4 weeks.
Standard of Care Treatment: Standard of Care treatment will include foam dressing and 4 layer compression therapy, changed weekly.
|
|---|---|---|
|
Percent Rate of Healing Versus Non-healing Wounds Within Each Treatment Group
Healing
|
62.5 percentage of participants
|
21.4 percentage of participants
|
|
Percent Rate of Healing Versus Non-healing Wounds Within Each Treatment Group
Non-healing
|
37.5 percentage of participants
|
78.6 percentage of participants
|
Adverse Events
Wound Edge Debridement Group
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Care Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Wound Edge Debridement Group
n=27 participants at risk
Participants in this group will receive wound edge debridement in addition to standard of care (SOC) treatment for up to 4 weeks.
Wound Edge Debridement: Wound debridement is performed using a sharp, circular disposable curette to remove the slough, non-viable tissue and any fibrous tissue down to the vascular base.
Standard of Care Treatment: Standard of Care treatment will include foam dressing and 4 layer compression therapy, changed weekly.
|
Standard Care Group
n=14 participants at risk
Participants in this group will receive only the standard care of treatment for up to 4 weeks.
Standard of Care Treatment: Standard of Care treatment will include foam dressing and 4 layer compression therapy, changed weekly.
|
|---|---|---|
|
Cardiac disorders
Deep venous thrombosis
|
3.7%
1/27 • Number of events 1 • 4 weeks
|
0.00%
0/14 • 4 weeks
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place