Diabetic Foot Ulcers
Conditions
Brief summary
A randomized, controlled pilot study examining how cellular energetics related to various wound treatment therapies in patients with diabetic foot ulcers.
Interventions
DEVICEPowered Suction Pump (VAC Freedom)
continuous foam based negative pressure wound therapy
DEVICEPowered Suction Pump
continuous gauze based negative pressure wound therapy
DEVICEMWT
moist wound therapy
Sponsors
KCI USA, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Type II diabetes * Subject has a diabetic foot ulcer 5cm squared or greater * Subject's diabetic foot ulcer is chronic
Exclusion criteria
* HgbA1c of 12% or greater * Presence of cellulitis * Presence of osteomyelitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compare Energy Charge Between Wound Treatment Therapies | Day 0, Day 2, Day 7 | Energy charge is a calculated ratio of the parameters ATP (µg), ADP (µg), and AMP (µg) which are measured with the same unit. Energy Charge is calculated as follows: Energy Charge = (ATP + (0.5 \* ADP)) / (ATP + ADP + AMP) Where, ATP = Adenosine triphosphate, ADP = Adenosine diphosphate, AMP = Adenosine monophosphate |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| VAC NPWT Powered Suction Pump (VAC Freedom): continuous suction | 20 |
| Gauze-Based NPWT Powered Suction Pump: continuous suction | 21 |
| Moist Wound Therapy MWT: moist wound therapy | 9 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 0 |
| Overall Study | Other | 2 | 2 | 0 |
Baseline characteristics
| Characteristic | VAC NPWT | Gauze-Based NPWT | Moist Wound Therapy | Total |
|---|---|---|---|---|
| Age, Continuous | 53.6 years STANDARD_DEVIATION 9.8 | 53.9 years STANDARD_DEVIATION 8.4 | 56.0 years STANDARD_DEVIATION 9.1 | 54.1 years STANDARD_DEVIATION 9 |
| Race/Ethnicity, Customized Race/Ethnicity African American | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Asian/Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Caucasian | 14 Participants | 11 Participants | 6 Participants | 31 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic | 4 Participants | 6 Participants | 3 Participants | 13 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Other, not specified | 1 Participants | 2 Participants | 0 Participants | 3 Participants |
| Region of Enrollment United States | 20 Participants | 21 Participants | 9 Participants | 50 Participants |
| Sex: Female, Male Female | 5 Participants | 2 Participants | 3 Participants | 10 Participants |
| Sex: Female, Male Male | 15 Participants | 19 Participants | 6 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 21 | 0 / 9 |
| other Total, other adverse events | 12 / 20 | 9 / 21 | 3 / 9 |
| serious Total, serious adverse events | 4 / 20 | 1 / 21 | 2 / 9 |
Outcome results
Primary
Compare Energy Charge Between Wound Treatment Therapies
Energy charge is a calculated ratio of the parameters ATP (µg), ADP (µg), and AMP (µg) which are measured with the same unit. Energy Charge is calculated as follows: Energy Charge = (ATP + (0.5 \* ADP)) / (ATP + ADP + AMP) Where, ATP = Adenosine triphosphate, ADP = Adenosine diphosphate, AMP = Adenosine monophosphate
Time frame: Day 0, Day 2, Day 7
Population: Energy charge data was not available for all subjects on the study. Data was only recorded for the subjects listed above.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VAC NPWT | Compare Energy Charge Between Wound Treatment Therapies | Day 2 | 0.4601 Ratio | Standard Deviation 0.1399 |
| VAC NPWT | Compare Energy Charge Between Wound Treatment Therapies | Day 0 | 0.4732 Ratio | Standard Deviation 0.0333 |
| VAC NPWT | Compare Energy Charge Between Wound Treatment Therapies | Day 7 | 0.5289 Ratio | Standard Deviation 0.1395 |
| Gauze-Based NPWT | Compare Energy Charge Between Wound Treatment Therapies | Day 2 | 0.5535 Ratio | Standard Deviation 0.1377 |
| Gauze-Based NPWT | Compare Energy Charge Between Wound Treatment Therapies | Day 0 | 0.5607 Ratio | Standard Deviation 0.1586 |
| Gauze-Based NPWT | Compare Energy Charge Between Wound Treatment Therapies | Day 7 | 0.5322 Ratio | Standard Deviation 0.151 |
| Moist Wound Therapy | Compare Energy Charge Between Wound Treatment Therapies | Day 0 | 0.4873 Ratio | Standard Deviation 0.031 |
| Moist Wound Therapy | Compare Energy Charge Between Wound Treatment Therapies | Day 7 | 0.5022 Ratio | Standard Deviation 0.022 |
| Moist Wound Therapy | Compare Energy Charge Between Wound Treatment Therapies | Day 2 | 0.4927 Ratio | Standard Deviation 0.0379 |