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

Lymphedema Clinical Trial

Official title:

Intermittent, Gradient, Pneumatic Compression Plus Standard Compression for Hard-To-Heal Venous Ulcers in Subjects With Secondary Lymphedema and Chronic Venous Insufficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01079299
• Other study ID #: CL-VU-0308
• Status: Completed
• Phase: N/A
• First received: March 2, 2010
• Last updated: January 9, 2012
• Start date: December 2007
• Est. completion date: May 2010

Study information

• Verified date: August 2010
• Source: Calvary Hospital, Bronx, NY
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: May 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 95 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphedema

Intervention

Device:
• Intermittent, gradient, pneumatic compression device
lymphedema pump provides external compression in a segmental,gradient fashion

Locations

Country	Name	City	State
United States	Calvary Hospital, Center for Curative and Palliative Wound Care	Bronx	New York

Sponsors (3)

Lead Sponsor	Collaborator
Calvary Hospital, Bronx, NY	New York State Department of Health, RTS Family Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median Time to Wound Closure at 9 Months	Median number of days for complete healing in each treatment group	9 months	No