Effect of Intermittent Pneumatic Compression on Ulcer Healing in Subjects With Secondary Lymphedema
NCT ID: NCT01079299
Last Updated: 2012-02-10
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
52 participants
INTERVENTIONAL
2007-12-31
2010-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effectiveness of Double-layer Compression Therapy in the Healing of Chronic Venous Ulcers in Primary Health Care
NCT02364921
Effect of HPIPC for the Treatment of Ischemic Ulcers in Subjects With PAD
NCT01420289
VLU Non-Inferiority Study Comparing a Dual Action Pneumatic Compression Device to Multi-Layer Bandaging
NCT02680834
Effect of Hyaluronic Acid ECM on Venous Ulcers
NCT02930499
Intermittent Pneumatic Compression of the Thigh
NCT05659394
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
IPC plus standard compression
Intermittent, gradient, pneumatic compression device
lymphedema pump provides external compression in a segmental,gradient fashion
Standard compression alone
Intermittent, gradient, pneumatic compression device
lymphedema pump provides external compression in a segmental,gradient fashion
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Intermittent, gradient, pneumatic compression device
lymphedema pump provides external compression in a segmental,gradient fashion
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
21 Years
95 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
RTS Family Foundation
UNKNOWN
New York State Department of Health
OTHER_GOV
Calvary Hospital, Bronx, NY
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Center for curative and Palliative Wound Care, Calvary Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Calvary Hospital, Center for Curative and Palliative Wound Care
The Bronx, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CL-VU-0308
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.