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Trial record 24 of 288 for:    Lymphedema

Effect of Intermittent Pneumatic Compression on Ulcer Healing in Subjects With Secondary Lymphedema

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ClinicalTrials.gov Identifier: NCT01079299
Recruitment Status : Completed
First Posted : March 3, 2010
Results First Posted : February 10, 2012
Last Update Posted : February 10, 2012
Sponsor:
Collaborators:
RTS Family Foundation
New York State Department of Health
Information provided by:
Calvary Hospital, Bronx, NY

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lymphedema
Intervention Device: Intermittent, gradient, pneumatic compression device
Enrollment 52
Recruitment Details 52 subjects were treated, IPC n=27, Control n=25
Pre-assignment Details  
Arm/Group Title IPC Plus Standard Compression Standard Compression Alone
Hide Arm/Group Description [Not Specified] [Not Specified]
Period Title: Overall Study
Started 27 25
Completed 27 25
Not Completed 0 0
Arm/Group Title IPC Plus Standard Compression Standard Compression Alone Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 27 25 52
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 25 participants 52 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
11
  40.7%
13
  52.0%
24
  46.2%
>=65 years
16
  59.3%
12
  48.0%
28
  53.8%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants 25 participants 52 participants
66  (5.6) 59  (4.9) 62  (5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 25 participants 52 participants
Female
10
  37.0%
9
  36.0%
19
  36.5%
Male
17
  63.0%
16
  64.0%
33
  63.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 27 participants 25 participants 52 participants
27 25 52
1.Primary Outcome
Title Median Time to Wound Closure at 9 Months
Hide Description Median number of days for complete healing in each treatment group
Time Frame 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IPC Plus Standard Compression Standard Compression Alone
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 27 25
Median (Standard Error)
Unit of Measure: median number of days for complete heali
141  (24) 211  (29)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title IPC Plus Standard Compression Standard Compression Alone
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
IPC Plus Standard Compression Standard Compression Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
IPC Plus Standard Compression Standard Compression Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   0/27 (0.00%)   0/25 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
IPC Plus Standard Compression Standard Compression Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   0/27 (0.00%)   0/25 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Oscar M. Alvarez / Principal Investigator
Organization: Center for Curative and Palliative Wound Care Calvary Hospital
Phone: 718-518-2577
Responsible Party: Oscar M. Alvarez, PhD / Principal Investigator, Center for curative and Palliative Wound Care, Calvary Hospital
ClinicalTrials.gov Identifier: NCT01079299     History of Changes
Other Study ID Numbers: CL-VU-0308
First Submitted: March 2, 2010
First Posted: March 3, 2010
Results First Submitted: August 18, 2011
Results First Posted: February 10, 2012
Last Update Posted: February 10, 2012