STUDY: Effectiveness of a Novel Static Pneumatic Gradient Compression Therapy Device (SPGC) for the Treatment of Venous Leg Ulcers (VLU) and Chronic Venous Insufficiency (CVI)

Oscar M. Alvarez Ph.D., Martin E. Wendelken DPM, RN, Daphne Chivily RN, BSN, WOCN, Linda Champion, RN, BSN, Rachelle Parker, MD From the Center for Curative and Palliative Wound Care, Calvary Hospital, Bronx, NY, Department of Medicine, New York Medical College, Valhalla, NY 

Objectives:

To evaluate and compare the effects of SPGC on the healing rate of VLU and to collect clinical information regarding CVI symptom management, ease of use, and safety profile. 

Design:

This was a prospective, parallel, 12-week pilot non-inferiority study involving 15 consecutive VLU patients in an outpatient hospital-based wound care center. Healing rates in patients receiving compression therapy with SPGC were compared to healing rates in VLU patients treated with standard of care compression therapy (historical control) consisting of a modified Unna’s boot or 4-Layer Bandage Compression System. (4-LB)** 

Endpoints:

Wound healing outcomes were graded using Photodigital Plani-metry Software*** and a numerical scale of +3 to -3 (+3= complete closure, +2= >50% closure at 4 weeks, +1= 25-49% closure at 4 weeks, -1= 1-24% closure at 4 weeks, -2= no improvement, -3= wound deterioration). Lower leg edema was measured using ankle and calf circumference and local wound pain was measured using a 10-point visual analog scale (VAS). 

Results:

There were no significant differences in the mean wound score between the SPGC group (2.3) and the standard of care controls (2.0). Nine of the 15 patients (60%) in the SPGC group achieved 50% wound healing at 4 weeks compared to 52% in the control group. Reduction of wound pain and edema reduction was also similar between both groups. 

Conclusion:

In this pilot trial, compression therapy with SPCG was as effective as traditional compression bandage therapy. SPCG is easily self-applied, can be worn with normal shoes, and can be easily removed for showering and sleeping. Although SPCG cannot be used on every CVI patient, it may provide a cost-effective alternative for those who don’t want to visit the doctor weekly or want a more active lifestyle.

aero-wrap static pneumatic compression for treatment of venous leg ulcers and chronic venous insufficiency

Download study poster here.

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