Lymphedema
Conditions
Keywords
venous ulcer, secondary lymphedema, chronic lower leg ulceration
Brief 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).
Interventions
DEVICEIntermittent, gradient, pneumatic compression device
lymphedema pump provides external compression in a segmental,gradient fashion
Sponsors
RTS Family Foundation
New York State Department of Health
Calvary Hospital, Bronx, NY
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 95 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median Time to Wound Closure at 9 Months | 9 months | Median number of days for complete healing in each treatment group |
Countries
United States
Participant flow
Recruitment details
52 subjects were treated, IPC n=27, Control n=25
Participants by arm
| Arm | Count |
|---|---|
| IPC Plus Standard Compression | 27 |
| Standard Compression Alone | 25 |
| Total | 52 |
Baseline characteristics
| Characteristic | Standard Compression Alone | IPC Plus Standard Compression | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 12 Participants | 16 Participants | 28 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 11 Participants | 24 Participants |
| Age Continuous | 59 years STANDARD_DEVIATION 4.9 | 66 years STANDARD_DEVIATION 5.6 | 62 years STANDARD_DEVIATION 5 |
| Region of Enrollment United States | 25 participants | 27 participants | 52 participants |
| Sex: Female, Male Female | 9 Participants | 10 Participants | 19 Participants |
| Sex: Female, Male Male | 16 Participants | 17 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 27 | 0 / 25 |
| serious Total, serious adverse events | 0 / 27 | 0 / 25 |
Outcome results
Primary
Median Time to Wound Closure at 9 Months
Median number of days for complete healing in each treatment group
Time frame: 9 months
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| IPC Plus Standard Compression | Median Time to Wound Closure at 9 Months | 141 median number of days for complete heali | Standard Error 24 |
| Standard Compression Alone | Median Time to Wound Closure at 9 Months | 211 median number of days for complete heali | Standard Error 29 |