N/A
N=52
Effect of Intermittent Pneumatic Compression on Ulcer Healing in Subjects With Secondary Lymphedema
Lymphedema
Bottom Line
View on ClinicalTrials.gov: NCT01079299 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Feb 2012
Primary outcome: Primary: Median Time to Wound Closure at 9 Months — 141; 211 median number of days for complete heali
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Intermittent, gradient, pneumatic compression device (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Calvary Hospital, Bronx, NY
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Time to Wound Closure at 9 Months |
141; 211 | — |
Summary
This is a randomized, controlled, parallel group, open label, clinical trial to evaluate the effectiveness of intermittent, gradient, pneumatic compression (IPC)on the healing of venous ulcers in subjects diagnosed with chronic secondary lymphedema. Time to complete healing, healing rates, edema, wound pain, granulation tissue, and wound exudate (type and amount) will be compared between the IPC-treated group (IPC plus standard compression)and control (standard compression alone).
Eligibility Criteria
Inclusion Criteria
- Diagnosed with secondary lymphedema
- Presence of a venous ulcer that has not healed in more than 6 months
- Localized wound pain greater than 3 with VAS
- Ulcer must be on lower leg (below knee)
- Ulcer must be of venous etiology
- CVI proven by duplex studies
- Subject must have adequate arterial blood flow (ABI > 0.70)
- Subject must be able to tolerate compression bandages
- Subject must be ambulatory
- Capable of understanding consent process
Exclusion Criteria
- Wound infection
- Ulcer of non-venous etiology
- Ulcer on toes or plantar surface of the foot
- Subject taking any medication that in the opinion of the investigator affects wound healing
- Alcohol or drug abuse
- Active deep venous thrombosis (DVT)
- Subject has a cancer diagnosis
- Diabetic with hemoglobin A1C>12
- Arterial insufficiency ABI<0.70
- Subject is not capable of walking (wheelchair-bound or bed-bound)
- Subject currently enrolled in another clinical trial
- Moderate to severe congestive heart failure
Data sourced from ClinicalTrials.gov (NCT01079299). 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.