Trial Outcomes & Findings for Effect of Intermittent Pneumatic Compression on Ulcer Healing in Subjects With Secondary Lymphedema (NCT NCT01079299)
NCT ID: NCT01079299
Last Updated: 2012-02-10
Results Overview
Median number of days for complete healing in each treatment group
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
52 participants
Primary outcome timeframe
9 months
Results posted on
2012-02-10
Participant Flow
52 subjects were treated, IPC n=27, Control n=25
Participant milestones
| Measure |
IPC Plus Standard Compression
|
Standard Compression Alone
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
25
|
|
Overall Study
COMPLETED
|
27
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Intermittent Pneumatic Compression on Ulcer Healing in Subjects With Secondary Lymphedema
Baseline characteristics by cohort
| Measure |
IPC Plus Standard Compression
n=27 Participants
|
Standard Compression Alone
n=25 Participants
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Age Continuous
|
66 years
STANDARD_DEVIATION 5.6 • n=5 Participants
|
59 years
STANDARD_DEVIATION 4.9 • n=7 Participants
|
62 years
STANDARD_DEVIATION 5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=5 Participants
|
25 participants
n=7 Participants
|
52 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 9 monthsMedian number of days for complete healing in each treatment group
Outcome measures
| Measure |
IPC Plus Standard Compression
n=27 Participants
|
Standard Compression Alone
n=25 Participants
|
|---|---|---|
|
Median Time to Wound Closure at 9 Months
|
141 median number of days for complete heali
Standard Error 24
|
211 median number of days for complete heali
Standard Error 29
|
Adverse Events
IPC Plus Standard Compression
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Compression Alone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Oscar M. Alvarez / Principal Investigator
Center for Curative and Palliative Wound Care Calvary Hospital
Phone: 718-518-2577
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place