Arterial Ulcers, PVD
Conditions
Keywords
Ischemic ulcers, PAD, Intermittent Claudication Pain
Brief summary
To evaluate the effects of HPIPC for the treatment of symptoms of PAD
Interventions
DEVICEHigh pressure intermittent pneumatic compression (HPIPC)
Apply therapy for 45 minutes twice daily
BEHAVIORALExcercise
Treadmill walking 45 minutes once daily
Sponsors
Calvary Hospital, Bronx, NY
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Intermittent claudication \>6mo * Ischemic ulceration or ulcer of mixed (venous) etiology * ABI \< 0.7 * Ambulatory * Able to comply
Exclusion criteria
* Gangrene * M.I. within 6mo * Inability to walk * Wound infection * Systemic corticosteroids * HBO, Apligraf, Dermagraft within 6mo * Falsely elevated ankle to brachial index (ABI) * Inflammatory condition affecting healing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Percent Reduction in Wound Surface Area | baseline and 16 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Improvement in Peak Walking Time | 16 weeks | Percentage Improvement in the amount of time one can walk without pain |
| Perceived Improvement in Physical Function After 16 Weeks | 16 weeks | Percent improvement in SF-36 Quality of life (QOL) questionnaire score at baseline and at week-16. The higher the score on the SF-36 questionnaire the better the QOL. |
| Wound Pain as Determined by a Visual Analog 10 Point Scale (VAS) for Pain. | 16 weeks | Percent change (improvement)in mean VAS pain scores at baseline and at 16 weeks |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| HPIPC High Pressure Intermittent Pneumatic compression (HPIPC)to be performed for 1 hour twice daily | 18 |
| Excercise Walking on a graded treadmill for 45 minutes once daily | 16 |
| Total | 34 |
Baseline characteristics
| Characteristic | Excercise | HPIPC | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 4 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 14 Participants | 28 Participants |
| Age Continuous | 62 years STANDARD_DEVIATION 11 | 64 years STANDARD_DEVIATION 12 | 63 years STANDARD_DEVIATION 12 |
| Region of Enrollment United States | 16 participants | 18 participants | 34 participants |
| Sex: Female, Male Female | 6 Participants | 6 Participants | 12 Participants |
| Sex: Female, Male Male | 10 Participants | 12 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 18 | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 |
Outcome results
Primary
Mean Percent Reduction in Wound Surface Area
Time frame: baseline and 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HPIPC | Mean Percent Reduction in Wound Surface Area | 72 Percent reduction in wound surface area | Standard Error 22 |
| Excercise | Mean Percent Reduction in Wound Surface Area | 58 Percent reduction in wound surface area | Standard Error 15 |
p-value: 0.08695% CI: [10, 80]t-test, 2 sided
Secondary
Perceived Improvement in Physical Function After 16 Weeks
Percent improvement in SF-36 Quality of life (QOL) questionnaire score at baseline and at week-16. The higher the score on the SF-36 questionnaire the better the QOL.
Time frame: 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HPIPC | Perceived Improvement in Physical Function After 16 Weeks | 70 Percent improvement in Sf-36 QOL score | Standard Error 6 |
| Excercise | Perceived Improvement in Physical Function After 16 Weeks | 53 Percent improvement in Sf-36 QOL score | Standard Error 6 |
Secondary
Percent Improvement in Peak Walking Time
Percentage Improvement in the amount of time one can walk without pain
Time frame: 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HPIPC | Percent Improvement in Peak Walking Time | 96 Percentage Change | Standard Error 11 |
| Excercise | Percent Improvement in Peak Walking Time | 66 Percentage Change | Standard Error 9 |
p-value: <0.0595% CI: [10, 100]t-test, 2 sided
Secondary
Wound Pain as Determined by a Visual Analog 10 Point Scale (VAS) for Pain.
Percent change (improvement)in mean VAS pain scores at baseline and at 16 weeks
Time frame: 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HPIPC | Wound Pain as Determined by a Visual Analog 10 Point Scale (VAS) for Pain. | 80 Percent improvement in mean VAS pain sco | Standard Error 14 |
| Excercise | Wound Pain as Determined by a Visual Analog 10 Point Scale (VAS) for Pain. | 55 Percent improvement in mean VAS pain sco | Standard Error 9 |