Trial Outcomes & Findings for Immunonutrition for Diabetic Foot Ulcers (NCT NCT05281562)
NCT ID: NCT05281562
Last Updated: 2024-12-27
Results Overview
The PUSH Tool 3.0 will be used to score ulcers based on size (cm2), exudate amount, and tissue type present. The score ranges for size, exudate amount, and tissue type are 0-10, 0-3, and 0-4, respectively. For all categories, a higher score indicates a more severe ulcer. The score for each category is combined to generate a final score ranging from 0-17. A higher final score indicates a more severe ulcer. The treating physician will record ulcer scores using this tool at the time of consent and 6 weeks for both the standard of care group and experimental group and calculate the change in ulcer scores from consent to 6 weeks.
TERMINATED
PHASE2/PHASE3
1 participants
6 weeks
2024-12-27
Participant Flow
Participant milestones
| Measure |
Standard of Care Group
Patients will receive standard of care wound treatment as determined by a treating physician.
|
Immunonutrition Supplementation Group
Patients will receive a 6 week daily oral supply of 1.68 grams Omega-3 fatty acids, 4.5 grams L-Arginine, and 500 mg Vitamin C.
Lovaza: Daily dose of 1.68grams omega-3 fatty acids, 2 Lovaza pills per day.
L-Arginine Powder: Daily dose of 4.5 grams L-Arginine, powder form.
Vitamin C: Daily dose of 500 mg Vitamin C, powder form.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Standard of Care Group
Patients will receive standard of care wound treatment as determined by a treating physician.
|
Immunonutrition Supplementation Group
Patients will receive a 6 week daily oral supply of 1.68 grams Omega-3 fatty acids, 4.5 grams L-Arginine, and 500 mg Vitamin C.
Lovaza: Daily dose of 1.68grams omega-3 fatty acids, 2 Lovaza pills per day.
L-Arginine Powder: Daily dose of 4.5 grams L-Arginine, powder form.
Vitamin C: Daily dose of 500 mg Vitamin C, powder form.
|
|---|---|---|
|
Overall Study
Ineligible patient
|
1
|
0
|
Baseline Characteristics
Immunonutrition for Diabetic Foot Ulcers
Baseline characteristics by cohort
| Measure |
Standard of Care Group
n=1 Participants
Patients will receive standard of care wound treatment as determined by a treating physician.
|
Immunonutrition Supplementation Group
Patients will receive a 6 week daily oral supply of 1.68 grams Omega-3 fatty acids, 4.5 grams L-Arginine, and 500 mg Vitamin C.
Lovaza: Daily dose of 1.68grams omega-3 fatty acids, 2 Lovaza pills per day.
L-Arginine Powder: Daily dose of 4.5 grams L-Arginine, powder form.
Vitamin C: Daily dose of 500 mg Vitamin C, powder form.
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
63 years
STANDARD_DEVIATION 0 • n=5 Participants
|
—
|
63 years
STANDARD_DEVIATION 0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Only one study subject enrolled before study was closed and participant was withdrawn before 6 weeks. The study subject was enrolled to the no supplement arm; no subjects enrolled to treatment arm.
The PUSH Tool 3.0 will be used to score ulcers based on size (cm2), exudate amount, and tissue type present. The score ranges for size, exudate amount, and tissue type are 0-10, 0-3, and 0-4, respectively. For all categories, a higher score indicates a more severe ulcer. The score for each category is combined to generate a final score ranging from 0-17. A higher final score indicates a more severe ulcer. The treating physician will record ulcer scores using this tool at the time of consent and 6 weeks for both the standard of care group and experimental group and calculate the change in ulcer scores from consent to 6 weeks.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 6 weeksPopulation: Only one study subject enrolled before study was closed and participant was withdrawn before 6 weeks. The study subject was enrolled to the no supplement arm; no subjects enrolled to treatment arm.
Patients in both the standard of care and experimental groups will report visual analog scale (VAS) pain scores at 6 weeks.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 weeksPopulation: Only one study subject enrolled before study was closed and participant was withdrawn before 6 weeks. The study subject was enrolled to the no supplement arm; no subjects enrolled to treatment arm.
Patients in experimental group will complete a survey detailing their satisfaction with the supplemental immunonutrition regimen following completion of study participation. Patients will be asked to rate their satisfaction from very satisfied to very unsatisfied and questions regarding their likelihood to partake in the same treatment regimen for a subsequent ulcer, recommend this treatment regimen to others, and the level of difficulty associated with taking the supplementation.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: Only one study subject enrolled before study was closed and participant was withdrawn before 1 year. The study subject was enrolled to the no supplement arm; no subjects enrolled to treatment arm.
Study participants in both the standard of care and experimental groups will be monitored via chart review for one year following the completion of their study participation to assess recurrence rates of diabetic foot ulcers and to identify rate of infection, surgical intervention, and amputation.
Outcome measures
Outcome data not reported
Adverse Events
Standard of Care Group
Immunonutrition Supplementation Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place