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Clinical Trial Summary

The purpose of this study is to determine whether low level laser light therapy is effective as an adjunctive therapy to the healing of venous stasis leg ulcers.


Clinical Trial Description

A chronic venous stasis leg ulcer is a wound below the knee that fails to heal within 6 weeks. Venous stasis ulcers account for 80% to 90% of all leg and foot ulcers, affecting an estimated 500,000-600,000 people in the United States every year. Venous stasis ulcers account for the loss of 2 million working days and incur treatment costs around $3 billion dollars annually in the United States. Standard of care for venous stasis ulcers includes compression of the affected leg together with daily dressing changes to minimize swelling; debridement of the ulcer to remove dead tissue and bacteria; and daily wound Care dressing to keep the wound clean. Venous stasis ulcers typically have very lengthy and poor healing rates, with up to 50% remaining open and unhealed for 9 months or longer. Many patients suffer pain and sleep and mobility problems, impairing quality of life. Recurrence rates for venous stasis ulcers is very high, with about one third of treated individuals experiencing 4 or more episodes of ulceration.

Low level laser light therapy (LLLT), with its proven tissue healing acceleration properties has recently gained attention as a simple, non-invasive alternative adjunctive therapy to assist in both wound closure and accelerated time to wound closure. Numerous histological trials have exhibited laser therapy's capacity to upregulate essential wound-healing factors such as vascular endothelial growth factor (VEGF), basic fibroblast growth factor (bFGF), oxygen concentration, fibroblast proliferation, collagen synthesis, re-epithelialization, and tissue granulation. Clinically, the application of laser therapy has demonstrated promise, accelerating the rate of wound healing and tissue contracture. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01376050
Study type Interventional
Source Erchonia Corporation
Contact
Status Terminated
Phase N/A
Start date June 2011
Completion date December 2013

See also
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Terminated NCT01612806 - A Multi-center, Prospective, Randomized Study With PriMatrix and PriMatrix Ag for the Treatment of Venous Leg Ulcers N/A
Completed NCT00900029 - Safety Follow-Up to HP 802-247-09-015 N/A
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Recruiting NCT02322554 - Cellular and Tissue Based Therapy Registry
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Recruiting NCT04647240 - Dermacyte® Amniotic Wound Care Liquid for the Treatment of Non-Healing Venous Stasis Ulcers Phase 2
Completed NCT02395302 - Evaluation of a Dual Action Pneumatic Compression System: Tolerance and Comfort in Patients With Venous Leg Ulcers N/A
Completed NCT00270946 - Evaluation of Bilayered Cellular Matrix (OrCel) for the Treatment of Venous Ulcers N/A