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Single-use negative pressure wound therapy (PICO 7) is a safe and feasible alternative to conventional care for chronic lower limb wounds, with favorable trends in wound area reduction but no statistically significant between-group difference.

In a randomized controlled trial of 31 patients with chronic lower limb wounds, the PICO 7 group showed a higher mean percentage reduction in wound size compared to usual care, but the difference was not statistically significant. No infections were recorded in the PICO 7 group, and quality of life and physical activity remained stable in the intervention group while declining in the control group. A significant negative correlation was found between final wound size and hours of sleep, suggesting wound reduction facilitates better rest.

Last updated: Aug 28, 2026•1 RCTs•📖 Read as article →

Evidence Score

Evidence Score48/100
Human RCT★★☆☆☆
Meta-analysis☆☆☆☆☆
Mechanism★★★★★
Safety★★★★☆
Confidencelow

Study Evidence

Study 1. Effectiveness of Single-Use Negative Pressure Wound Therapy (Pico 7) in Chronic Lower Limb Wounds: A Randomized Clinical Trial.

rct

Villalba-Aguilar C, Laredo-Aguilera JA, Villalba-Aguilar L, Barroso-Corroto E, Del Viso-Cudero C, Serrano-Fernández V, Carmona-Torres JM · Journal of clinical medicine (2026)

Participants: 31
Duration: Not specified (study period 2024-2026)
Intervention: Single-use negative pressure wound therapy (PICO 7) compared to usual treatment, with both groups following the dynamic TIME strategy for wound bed preparation.
Outcome: Healing rate, healing time, wound area reduction, clinical safety (infections and adverse effects), pain levels, health-related quality of life, physical activity, and hours of sleep.
Effect Size: N/A (between-group difference not statistically significant)
Population: Patients with chronic lower limb wounds (diabetic and vascular ulcers) or dehiscence in amputations at Hospital Universitario de Toledo.

Result: In a randomized controlled trial of 31 patients with chronic lower limb wounds, the PICO 7 group showed a higher mean percentage reduction in wound size compared to usual care, but the difference was not statistically significant. No infections were recorded in the PICO 7 group, and quality of life and physical activity remained stable in the intervention group while declining in the control group. A significant negative correlation was found between final wound size and hours of sleep, suggesting wound reduction facilitates better rest.

PubMed: 42652778DOI: 10.3390/jcm15166373

Mechanism Graph

PICO 7 applies continuous negative pressure to the wound bed
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Negative pressure promotes wound contraction and fluid removal
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Reduced wound size and exudate may improve local tissue perfusion and reduce infection risk
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Improved wound healing may lead to better sleep quality and overall well-being

Limitations

  • ⚠Small sample size (31 patients) limits statistical power and generalizability
  • ⚠Open-label design may introduce bias in outcome assessment
  • ⚠No statistically significant between-group difference in primary outcomes, so conclusions are cautious

Frequently Asked Questions

What is PICO 7 and how does it work?▼

PICO 7 is a single-use, portable negative pressure wound therapy system that applies continuous suction to the wound, helping to reduce wound size and exudate, and potentially improving healing.

Is PICO 7 effective for chronic lower limb wounds?▼

This study found favorable trends in wound area reduction with PICO 7 compared to usual care, but the difference was not statistically significant. It was safe, with no infections in the intervention group.

Does PICO 7 affect quality of life or sleep?▼

The intervention group maintained stable quality of life and physical activity, while the control group declined. A significant negative correlation was found between final wound size and hours of sleep, suggesting better wound healing may improve sleep.

What are the limitations of this study?▼

The study had a small sample size and was open-label, which may introduce bias. The lack of statistical significance in primary outcomes means results should be interpreted cautiously.

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References

  1. 1.Villalba-Aguilar C, Laredo-Aguilera JA, Villalba-Aguilar L, Barroso-Corroto E, Del Viso-Cudero C, Serrano-Fernández V, Carmona-Torres JM. "Effectiveness of Single-Use Negative Pressure Wound Therapy (Pico 7) in Chronic Lower Limb Wounds: A Randomized Clinical Trial.." Journal of clinical medicine, 2026. PMID: 42652778 DOI: 10.3390/jcm15166373
Disclaimer: This content is for educational purposes only and is not medical advice. Evidence scores reflect the quality and quantity of available research, not clinical recommendations. Always consult a healthcare professional before starting any supplement or intervention.