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

NCT01079299 | Completed Results

• 1 other identifier: CL-VU-0308
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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).

Conditions

Lymphedema

Keywords

venous ulcer; secondary lymphedema; chronic lower leg ulceration

Outcome Measures

Primary Outcomes (1)

• Median Time to Wound Closure at 9 Months

  Median number of days for complete healing in each treatment group

  9 months

Study Arms (2)

IPC plus standard compression

EXPERIMENTAL

Device: Intermittent, gradient, pneumatic compression device

Standard compression alone

ACTIVE COMPARATOR

Device: Intermittent, gradient, pneumatic compression device

Interventions

Intermittent, gradient, pneumatic compression device DEVICE

lymphedema pump provides external compression in a segmental,gradient fashion

Also known as: Bio 4000 (Bio Compression Inc, Moonachie,NJ)

IPC plus standard compression; Standard compression alone

Eligibility Criteria

• Age: 21 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Calvary Hospital, Bronx, NY: lead
• RTS Family Foundation: collaborator
• New York State Department of Health: collaborator

Study Sites (1)

Calvary Hospital, Center for Curative and Palliative Wound Care

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Lymphedema; Varicose Ulcer

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Oscar M. Alvarez / Principal Investigator
• Organization: Center for Curative and Palliative Wound Care Calvary Hospital

oalvarez@calvaryhospital.org

718-518-2577

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 2, 2010
• First Posted: March 3, 2010
• Study Start: December 1, 2007
• Primary Completion: April 1, 2010
• Study Completion: May 1, 2010
• Last Updated: February 10, 2012
• Results First Posted: February 10, 2012

Record last verified: 2010-08

Locations

US (1)