Trial Outcomes & Findings for Characterization of AmnioExcel Plus in Two Treatment Paradigms (NCT NCT04233580)
NCT ID: NCT04233580
Last Updated: 2023-07-24
Results Overview
Number of participants whose wounds healed during the study timeframe. Reported as dichotomous yes/no.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
12 weeks
Results posted on
2023-07-24
Participant Flow
Participant milestones
| Measure |
Weekly AmnioEXCEL+ Group
AmnioEXCEL+ will be applied weekly at study visits
Amnio Excel + weekly: Amnio Excel + weekly
|
PRN AmnioEXCEL+ Group
AmnioEXCEL+ will be applied maximum every 2 weeks (PRN, in the case that the wound requires debridement at a visit not intended for AE+ application, the wound will be treated as SOC)
Amnio Excel + max every 2 weeks: Amnio Excel + max every 2 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
15
|
16
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
Reasons for withdrawal
| Measure |
Weekly AmnioEXCEL+ Group
AmnioEXCEL+ will be applied weekly at study visits
Amnio Excel + weekly: Amnio Excel + weekly
|
PRN AmnioEXCEL+ Group
AmnioEXCEL+ will be applied maximum every 2 weeks (PRN, in the case that the wound requires debridement at a visit not intended for AE+ application, the wound will be treated as SOC)
Amnio Excel + max every 2 weeks: Amnio Excel + max every 2 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
Baseline Characteristics
Characterization of AmnioExcel Plus in Two Treatment Paradigms
Baseline characteristics by cohort
| Measure |
Weekly AmnioEXCEL+ Group
n=20 Participants
AmnioEXCEL+ will be applied weekly at study visits
Amnio Excel + weekly: Amnio Excel + weekly
|
PRN AmnioEXCEL+ Group
n=20 Participants
AmnioEXCEL+ will be applied maximum every 2 weeks (PRN, in the case that the wound requires debridement at a visit not intended for AE+ application, the wound will be treated as SOC)
Amnio Excel + max every 2 weeks: Amnio Excel + max every 2 weeks
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.9 years
STANDARD_DEVIATION 15.3 • n=5 Participants
|
57.6 years
STANDARD_DEVIATION 9.8 • n=7 Participants
|
58.43 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Body mass index
|
32.2 kg/m^2
STANDARD_DEVIATION 7.8 • n=5 Participants
|
32.3 kg/m^2
STANDARD_DEVIATION 5.0 • n=7 Participants
|
32.3 kg/m^2
STANDARD_DEVIATION 6.6 • n=5 Participants
|
|
Neuropathy
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksNumber of participants whose wounds healed during the study timeframe. Reported as dichotomous yes/no.
Outcome measures
| Measure |
Weekly AmnioEXCEL+ Group
n=20 Participants
AmnioEXCEL+ will be applied weekly at study visits
Amnio Excel + weekly: Amnio Excel + weekly
|
PRN AmnioEXCEL+ Group
n=20 Participants
AmnioEXCEL+ will be applied maximum every 2 weeks (PRN, in the case that the wound requires debridement at a visit not intended for AE+ application, the wound will be treated as SOC)
Amnio Excel + max every 2 weeks: Amnio Excel + max every 2 weeks
|
|---|---|---|
|
Number of Participants Who Healed
|
6 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: BaselineWound volume measured by camera which performs a 3D measurement and calculates the volume at baseline
Outcome measures
| Measure |
Weekly AmnioEXCEL+ Group
n=20 Participants
AmnioEXCEL+ will be applied weekly at study visits
Amnio Excel + weekly: Amnio Excel + weekly
|
PRN AmnioEXCEL+ Group
n=20 Participants
AmnioEXCEL+ will be applied maximum every 2 weeks (PRN, in the case that the wound requires debridement at a visit not intended for AE+ application, the wound will be treated as SOC)
Amnio Excel + max every 2 weeks: Amnio Excel + max every 2 weeks
|
|---|---|---|
|
Wound Volume
|
1.2 cubic centimeters
Standard Deviation 3.27
|
0.53 cubic centimeters
Standard Deviation 1.44
|
SECONDARY outcome
Timeframe: BaselineWound measured by camera which performs a 3D measurement and calculates the area at baseline
Outcome measures
| Measure |
Weekly AmnioEXCEL+ Group
n=20 Participants
AmnioEXCEL+ will be applied weekly at study visits
Amnio Excel + weekly: Amnio Excel + weekly
|
PRN AmnioEXCEL+ Group
n=20 Participants
AmnioEXCEL+ will be applied maximum every 2 weeks (PRN, in the case that the wound requires debridement at a visit not intended for AE+ application, the wound will be treated as SOC)
Amnio Excel + max every 2 weeks: Amnio Excel + max every 2 weeks
|
|---|---|---|
|
Wound Area
|
3.98 square centimeters
Standard Deviation 4.87
|
3.15 square centimeters
Standard Deviation 4.05
|
SECONDARY outcome
Timeframe: BaselineTissue oxygenation measured by hyperspectral imaging camera at baseline
Outcome measures
| Measure |
Weekly AmnioEXCEL+ Group
n=20 Participants
AmnioEXCEL+ will be applied weekly at study visits
Amnio Excel + weekly: Amnio Excel + weekly
|
PRN AmnioEXCEL+ Group
n=20 Participants
AmnioEXCEL+ will be applied maximum every 2 weeks (PRN, in the case that the wound requires debridement at a visit not intended for AE+ application, the wound will be treated as SOC)
Amnio Excel + max every 2 weeks: Amnio Excel + max every 2 weeks
|
|---|---|---|
|
Tissue Oxygenation (StO2) of the Dorsal Foot
|
65.89 percentage of oxygen saturation
Standard Deviation 15.41
|
65.70 percentage of oxygen saturation
Standard Deviation 9.31
|
Adverse Events
Weekly AmnioEXCEL+ Group
Serious events: 6 serious events
Other events: 9 other events
Deaths: 0 deaths
PRN AmnioEXCEL+ Group
Serious events: 5 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Weekly AmnioEXCEL+ Group
n=20 participants at risk
AmnioEXCEL+ will be applied weekly at study visits
Amnio Excel + weekly: Amnio Excel + weekly
|
PRN AmnioEXCEL+ Group
n=20 participants at risk
AmnioEXCEL+ will be applied maximum every 2 weeks (PRN, in the case that the wound requires debridement at a visit not intended for AE+ application, the wound will be treated as SOC)
Amnio Excel + max every 2 weeks: Amnio Excel + max every 2 weeks
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Below knee amputation
|
5.0%
1/20 • Number of events 1 • 12 weeks
|
5.0%
1/20 • Number of events 1 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Infection
|
15.0%
3/20 • Number of events 3 • 12 weeks
|
15.0%
3/20 • Number of events 3 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Trauma to foot
|
0.00%
0/20 • 12 weeks
|
5.0%
1/20 • Number of events 1 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Ulcer worsening
|
5.0%
1/20 • Number of events 1 • 12 weeks
|
0.00%
0/20 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Abrasion
|
5.0%
1/20 • Number of events 1 • 12 weeks
|
0.00%
0/20 • 12 weeks
|
Other adverse events
| Measure |
Weekly AmnioEXCEL+ Group
n=20 participants at risk
AmnioEXCEL+ will be applied weekly at study visits
Amnio Excel + weekly: Amnio Excel + weekly
|
PRN AmnioEXCEL+ Group
n=20 participants at risk
AmnioEXCEL+ will be applied maximum every 2 weeks (PRN, in the case that the wound requires debridement at a visit not intended for AE+ application, the wound will be treated as SOC)
Amnio Excel + max every 2 weeks: Amnio Excel + max every 2 weeks
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
New ulcer development
|
15.0%
3/20 • Number of events 3 • 12 weeks
|
10.0%
2/20 • Number of events 2 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Infection
|
20.0%
4/20 • Number of events 4 • 12 weeks
|
25.0%
5/20 • Number of events 5 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain
|
10.0%
2/20 • Number of events 2 • 12 weeks
|
0.00%
0/20 • 12 weeks
|
Additional Information
Tara Kristof
University of Texas Southwestern Medical Center
Phone: 214-648-8602
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place