LymphedemaNCT01079299
Effect of Intermittent Pneumatic Compression on Ulcer Healing in Subjects With Secondary Lymphedema
A study testing Intermittent, gradient, pneumatic compression device in people with Lymphedema, run by Calvary Hospital, Bronx, NY at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 95 years
- Conditions the study is for
- Lymphedema
- What is being tested?
- Intermittent, gradient, pneumatic compression device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to May 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Calvary Hospital, Center for Curative and Palliative Wound Care
The Bronx, New York, 10461
About this study
Official title: Intermittent, Gradient, Pneumatic Compression Plus Standard Compression for Hard-To-Heal Venous Ulcers in Subjects With Secondary Lymphedema and Chronic Venous Insufficiency
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).
- Conditions
- Lymphedema
- Being tested
- Intermittent, gradient, pneumatic compression device
- Keywords
- venous ulcer, secondary lymphedema, chronic lower leg ulceration
- Medical subject headings
- Lymphedema, Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent, gradient, pneumatic compression deviceDevice
Also called Bio 4000 (Bio Compression Inc, Moonachie,NJ)
lymphedema pump provides external compression in a segmental,gradient fashion
| Study group | Role | What they receive |
|---|---|---|
| IPC plus standard compression | Experimental | Not described Receives: Device: Intermittent, gradient, pneumatic compression device |
| Standard compression alone | Active comparator | Not described Receives: Device: Intermittent, gradient, pneumatic compression device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Time to Wound Closure at 9 Months
Median number of days for complete healing in each treatment group
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2010 (estimated)
- Study startDec 2007
- Primary completionApr 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Calvary Hospital, Bronx, NY
- Sponsor type
- University, hospital or other
- Collaborators
- RTS Family Foundation, New York State Department of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01079299
- Sponsor's protocol ID
- CL-VU-0308
- Status last verified
- Aug 2010
- First submitted
- 2 Mar 2010
- Last updated
- 10 Feb 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent, Gradient, Pneumatic Compression Plus Standard Compression for Hard-To-Heal Venous Ulcers in Subjects With Secondary Lymphedema and Chronic Venous Insufficiency
- ClinicalTrials.gov ID
- NCT01079299
- Acronym / sponsor ID
- CL-VU-0308
- Conditions
- Lymphedema
- Keywords
- venous ulcer, secondary lymphedema, chronic lower leg ulceration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Calvary Hospital, Bronx, NYUniversity, hospital or other
- Collaborators
- RTS Family Foundation, New York State Department of Health
- Study start
- Dec 2007
- Primary completion
- Apr 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 3 Mar 2010 (estimated)
- Results
- Posted 10 Feb 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IPC plus standard compression | Experimental | Device: Intermittent, gradient, pneumatic compression device |
| Standard compression alone | Active comparator | Device: Intermittent, gradient, pneumatic compression device |
Who may qualify
- Ages
- 21 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent, gradient, pneumatic compression deviceAlso: Bio 4000 (Bio Compression Inc, Moonachie,NJ)lymphedema pump provides external compression in a segmental,gradient fashion | Device | IPC plus standard compression, Standard compression alone |
Primary outcome
Median Time to Wound Closure at 9 Months
Time frame: 9 months
Median number of days for complete healing in each treatment group
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Lymphedema
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
Enrolling by invitation
Comparison of the Effects of Kinesio Taping and Compression Bandaging on Edema, Range of Motion, Upper Extremity Function, and Grip Strength in Patients With Breast Cancer-Related Lymphedema
Lymphedema, Lymphedema Arm
RecruitingObservational study
A Post-market, Real-world Experience: Expanding Access to Care by Incorporating the Symani® Surgical System and Enabling Surgeons
Open Surgery, Lymphedema
Not yet recruiting
Agentic AI App and Home Bioimpedance Monitoring for Endocrine Therapy Adherence and Lymphedema in Breast Cancer Survivors
Breast Neoplasm Malignant Primary, Lymphedema Arm
Active, not recruiting
The Effectiveness of Lymphatic Bypass Supermicrosurgery
Breast Cancer Related Lymphedema, Lymphedema Arm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent, gradient, pneumatic compression device in people with Lymphedema, run by Calvary Hospital, Bronx, NY at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Feb 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median Time to Wound Closure at 9 Months (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2012.