Lower extremity evidence

Significant reductions in wound area, depth and volume with use of PICO Single Use Negative Pressure Wound Therapy System (sNPWT) versus traditional negative pressure wound therapy (tNPWT) in patients with lower extremity ulcers.

Kirsner R, et al. Wound Rep Regen. (2019)1

Why was the study performed?

This study evaluated whether PICO sNPWT was as effective as tNPWT at managing lower extremity ulcers.1

Three people

>6 million people

affected by chronic wounds in USA2

Foot with chronic wounds

VLUs and DFUs

are common chronic wounds3

What was done?

Man with magnifying glass
A randomized, controlled study was performed at 18 centers in the USA and Canada1
calendar
For 12 weeks or until closure of the target ulcer, patients were treated with either PICO sNPWT or tNPWT (one of four similar devices)1
Foot with wound
A filler was used for all wounds treated with tNPWT, but the investigator could choose whether to use a filler with PICO sNPWT1

Which patients were included?

three people

 

164 patients enrolled1

with lower extremity ulcers (>4 weeks duration)

male and female

Males (63.4%)
Females (36.6%)

61.5 years

Mean age

foor with wound

104 with VLUs (2–36cm2)
60 with DFUs (0.5–10cm2)

How the populations were analyzed

Safety1

80 PICO sNPWT
84 tNPWT

Evaluate safety in all patients enrolled who received either treatment1

 

Per protocol (PP)1

64 PICO sNPWT
51 tNPWT

Show non-inferiority versus tNPWT in all patients treated as planned1

 

Intention to treat (ITT)1

80 PICO sNPWT
81 tNPWT

Confirm superiority versus tNPWT in all patients who attended a follow up visit1

What were the main results?

**These statistics come from two patient populations, which include outliers in the dataset.

ITT population (n=161)

Wound closure

Twice as many wounds closed
at 12 weeks with PICO sNPWT than tNPWT

(45 vs 22%; p=0.002; ITT population)1

What did it demonstrate?

Use of PICO sNPWT helped to significantly reduce wound area, volume and depth compared with tNPWT in patients with lower extremity ulcers over 12 weeks.1 More patients achieved wound closure1 and overall satisfaction was greater4 with PICO sNPWT than with tNPWT in this randomized controlled study.

   

Dollar symbol

The PICO System

saved an estimated $7K per patient over 12 weeks vs. traditional NPWT on lower extremity wounds.3*†‡

* n=161; † n=52; ‡ Based on cost modeling analysis compared with tNPWT

 

PICO sNPWT is not indicated for compression therapy.

Application of PICO 7 sNPWT on a leg ulcer

 

    1. Kirsner R, Dove C, Reyzelman A, Vayser D, Jaimes H. A prospective, randomized, controlled clinical trial on the efficacy of a single-use negative pressure wound therapy system, compared to traditional negative pressure wound therapy in the treatment of chronic ulcers of the lower extremities. Wound Repair Regen. 2019 Sept;27(5):519-529.
    2. Powers JG, Higham C, Broussard K, Phillips TJ. Wound healing and treating wounds: Chronic wound care and management. J Am Acad Dermatol. 2016;74(4):607-25;
    3. Werdin F, Tenenhaus M, Rennekampff HO. Chronic wound care. Lancet. 2008 9;372(9653):1860-1862;
    4. Kirsner R, Dove C, Reyzelman A, Vayser D, Jaimes H. Randomized controlled trial on the efficacy and acceptance of a single-use negative pressure wound therapy system versus traditional negative pressure wound therapy in the treatment of lower limb chronic ulcers (VLU and DFU). Poster presented at the 10th Annual Abu Dhabi Wound Care Conference, March 23–24, 2019. Abu Dhabi, United Arab Emirates.
    5. Kirsner RS, Delhougne G, Searle RJ. A cost-effectiveness analysis comparing single-use and traditional negative pressure wound therapy to treat chronic venous and diabetic foot ulcers. Wound Manag Prev. 2020;66(3):30-38.

* Joy, H et al. A collaborative project to enhance efficiency through dressing change practice. Journal of Wound Care 2015;24(7):312,314-7