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

Overview

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).

Full Title of Study: “Intermittent, Gradient, Pneumatic Compression Plus Standard Compression for Hard-To-Heal Venous Ulcers in Subjects With Secondary Lymphedema and Chronic Venous Insufficiency”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2010

Interventions

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

Arms, Groups and Cohorts

  • Experimental: IPC plus standard compression
  • Active Comparator: Standard compression alone

Clinical Trial Outcome Measures

Primary Measures

  • Median Time to Wound Closure at 9 Months
    • Time Frame: 9 months
    • Median number of days for complete healing in each treatment group

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: 95 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Calvary Hospital, Bronx, NY
  • Collaborator
    • RTS Family Foundation
  • Provider of Information About this Clinical Study
    • Oscar M. Alvarez, PhD / Principal Investigator, Center for curative and Palliative Wound Care, Calvary Hospital

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