N/A
Completed N=34
Effect of HPIPC for the Treatment of Ischemic Ulcers in Subjects With PAD
PVD · Arterial Ulcers
Source: ClinicalTrials.gov NCT01420289 ↗
Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Feb 2012
Primary outcomePrimary: Mean Percent Reduction in Wound Surface Area — 72; 58 Percent reduction in wound surface area — p=0.086
Summary
To evaluate the effects of HPIPC for the treatment of symptoms of PAD
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Percent Reduction in Wound Surface Area |
72; 58 | 0.086 |
| SECONDARY Percent Improvement in Peak Walking Time |
96; 66 | <0.05 sig |
| SECONDARY Perceived Improvement in Physical Function After 16 Weeks |
70; 53 | — |
| SECONDARY Wound Pain as Determined by a Visual Analog 10 Point Scale (VAS) for Pain. |
80; 55 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01420289). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.